TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Disclaimer © International Finance Corporation 2022. All rights reserved. 2121 Pennsylvania Avenue, N.W. Washington, D.C. 20433 Internet: www.ifc.org The material in this work is copyrighted. Copying and/or transmitting portions or all of this work without permission may be a violation of applicable law. 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TABLE OF CONTENTS Acronyms/Abbreviations.......................................................................................... 6 Acknowledgements................................................................................................ 10 Foreword................................................................................................................11 PART 1: GENERAL.................................................................................................... 12 1.1 Background..................................................................................................... 12 1.2 Guide objectives and limitations........................................................................ 12 1.3 How to use the guide....................................................................................... 13 1.4 Products covered by the guide.......................................................................... 14 1.5 Markets covered by the guide........................................................................... 18 1.6 Guidance for purchasers of COVID-19-related PPE................................................ 23 PART 2: OVERVIEW OF PRODUCT CATEGORIES.......................................................... 25 2.1 Masks............................................................................................................26 2.2 Eye and face protection................................................................................... 32 2.3 Gloves........................................................................................................... 36 2.4 Clothing........................................................................................................ 41 PART 3: OVERVIEW OF MARKET REQUIREMENTS...................................................... 50 3.1 European Union...............................................................................................50 3.2 United States.................................................................................................. 55 3.3 Australia........................................................................................................59 3.4 Brazil.............................................................................................................62 3.5 Canada..........................................................................................................65 3.6 Colombia.......................................................................................................69 3.7 India.............................................................................................................. 72 3.8 Jordan............................................................................................................ 75 3.9 Kenya............................................................................................................ 79 3.10 Malaysia.......................................................................................................82 3.11 South Africa...................................................................................................86 3.12 United Kingdom............................................................................................ 90 3.13 Vietnam........................................................................................................ 93 PART 4: PRODUCT-SPECIFIC COMPARISONS OF EU AND US MARKETS.......................... 97 4.1 Masks............................................................................................................ 97 4.2 Eye and face protection................................................................................. 108 4.3 Gloves.......................................................................................................... 112 3 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 4.4 Clothing....................................................................................................... 121 PART 5: PRODUCT-SPECIFIC COMPARISONS (AUSTRALIA)..........................................132 5.1 Masks........................................................................................................... 132 5.2 Eye and face protection..................................................................................136 5.3 Gloves...........................................................................................................138 5.4 Clothing.......................................................................................................142 PART 6: PRODUCT-SPECIFIC COMPARISONS (BRAZIL)............................................... 146 6.1 Masks.......................................................................................................... 146 6.2 Eye and face protection.................................................................................. 151 6.3 Gloves..........................................................................................................152 6.4 Clothing....................................................................................................... 155 PART 7: PRODUCT-SPECIFIC COMPARISONS (CANADA).............................................. 161 7.1 Masks............................................................................................................ 161 7.2 Eye and face protection...................................................................................163 7.3 Gloves.......................................................................................................... 164 7.4 Clothing........................................................................................................165 PART 8: PRODUCT-SPECIFIC COMPARISONS (COLOMBIA).......................................... 168 8.1 Masks.......................................................................................................... 168 8.2 Eye and face protection.................................................................................. 172 8.3 Gloves.......................................................................................................... 173 8.4 Clothing....................................................................................................... 175 PART 9: PRODUCT-SPECIFIC COMPARISONS (INDIA)..................................................183 9.1 Masks...........................................................................................................183 9.2 Eye and face protection................................................................................. 186 9.3 Gloves..........................................................................................................188 9.4 Clothing....................................................................................................... 191 PART 10: PRODUCT-SPECIFIC COMPARISONS (JORDAN).............................................197 10.1 Masks..........................................................................................................197 10.2 Eye and face protection................................................................................ 201 10.3 Gloves........................................................................................................ 202 10.4 Clothing..................................................................................................... 205 PART 11: PRODUCT-SPECIFIC COMPARISONS (KENYA)................................................ 211 11.1 Masks........................................................................................................... 211 11.2 Eye and face protection.................................................................................. 215 11.3 Gloves..........................................................................................................216 11.4 Clothing.......................................................................................................219 PART 12: PRODUCT-SPECIFIC COMPARISONS (MALAYSIA)......................................... 226 12.1 Masks......................................................................................................... 226 4 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 12.2 Eye and face protection................................................................................ 229 12.3 Gloves........................................................................................................ 229 12.4 Clothing..................................................................................................... 232 PART 13: PRODUCT-SPECIFIC COMPARISONS (SOUTH AFRICA)................................... 235 13.1 Masks......................................................................................................... 235 13.2 Eye and face protection................................................................................ 238 13.3 Gloves........................................................................................................ 239 13.4 Clothing..................................................................................................... 242 PART 14: PRODUCT-SPECIFIC COMPARISONS (UK).................................................... 245 14.1 Masks......................................................................................................... 245 14.2 Eye and face protection................................................................................ 249 14.3 Gloves........................................................................................................ 250 14.4 Clothing..................................................................................................... 253 PART 15: PRODUCT-SPECIFIC COMPARISONS (VIETNAM)........................................... 258 15.1 Masks......................................................................................................... 258 15.2 Eye and face protection.................................................................................261 15.3 Gloves.........................................................................................................261 15.4 Clothing..................................................................................................... 264 ANNEX A: OTHER CONSIDERATIONS FOR MANUFACTURERS AND PURCHASERS OF COVID-19-RELATED PPE................................................................ 268 A1 Sustainability of PPE....................................................................................... 268 A2 Diversity and inclusion in PPE.......................................................................... 269 A3 Approaches to conformity assessment and accreditation................................... 270 5 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets ACRONYMS/ABBREVIATIONS Acronym/ Explanation abbreviation AAMI Association for the Advancement of Medical Instrumentation (US) AATCC American Association of Textile Chemists and Colorists Associação Brasileira de Normas Técnicas ABNT (Brazilian National Standards Body) AFNOR French National Standards Body ANAB ANSI National Accreditation Board (US) ANSI American National Standards Institute Agência Nacional de Vigilância Sanitária ANVISA (Brazilian Health Regulatory Agency) Asia-Pacific Economic Cooperation Sub-Committee on Standards and APEC-SCSC Conformance APR Air-Purifying Respirator AQL Acceptable Quality Limit ARAC Arab Accreditation Cooperation AS Australian Standard AS/NZS Joint Australian/New Zealand Standard ASEAN Association of Southeast Asian Nations Formerly known as the American Society for Testing of Materials, now ASTM called ASTM International BFE Bacterial Filtration Efficiency BIS Bureau of Indian Standards BNQ Bureau de Normalisation du Québec (Québec Standards Bureau) BSI British Standards Institution CDC Center for Disease Control (US) CDSCO Central Drug Standard Control Organization (India) CE EU Mark of Conformity CEN European Committee for Standardization CENELEC European Committee for Electrotechnical Standardization CFR Code of Federal Regulations (US) CFS Certificate of Free Sale CFU Colony Forming Units (microbiology) CGCRE Brazilian National Accreditation Body cl. Clause 6 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets National Council of Metrology, Standardization and Industrial Quality CONMETRO (Brazil) Coronavirus Disease 2019 Caused by Severe Acute Respiratory Syndrome COVID-19 Coronavirus 2 (SARS-CoV-2) CSA Canadian Standards Association CSDT Common Submission Dossier Template CWA CEN Workshop Agreement DAkkS Deutsche Akkreditierungsstelle (German National Accreditation Body) DIN German National Standards Body DMEC Department of Medical Equipment and Construction (Vietnam) DSM Department of Standards Malaysia EA European Accreditation Cooperation EEC European Economic Community EN European Standard EU European Union FCDO Foreign, Commonwealth & Development Office (UK) FDA Food and Drug Administration (US) GB Chinese National Standard IAF International Accreditation Forum Instituto Colombiano de Normas Técnicas y Certificación (Colombian ICONTEC National Standards Body) IEC International Electrotechnical Commission IFC International Finance Corporation ILAC International Laboratory Accreditation Cooperation INMETRO National Institute of Metrology, Quality and Technology (Brazil) INVIMA National Institute for Food and Drug Surveillance (Colombia) ISEA International Safety Equipment Association (US) ISO International Organization for Standardization IVD In Vitro Diagnostic Product (medical device) JAS/ANZ Joint Accreditation Service for Australia and New Zealand JAS-AU Jordanian Accreditation and Standardization System—Accreditation Unit JFDA Jordan Food and Drug Administration JS Jordanian Standard JSMO Jordan Standards and Metrology Organization 7 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets KEBS Kenya Bureau of Standards KEMSA Kenya Medical Supplies Agency KENAS Kenya Accreditation Service KS Kenyan Standard L Large (size) M Medium (size) Malaysian Health Technology Assessment Section of the Ministry of MaHTAS Health MDA Medical Device Authority (Malaysia) MDEL Medical Device Establishment Licence (Canada) MDR (EU) Medical Devices Regulation (EU) 2017/745 MDR (India) Medical Devices Rules (India) MERCOSUL Southern Common Market (South American Trade Bloc) MLA Multilateral Recognition Arrangement (IAF) MRA Mutual Recognition Arrangement (ILAC) MS Malaysian Standard n/a Not Applicable NABCB National Accreditation Board for Certification Bodies (India) National Accreditation Board for Testing and Calibration Laboratories NABL (India) NANDO New Approach Notified and Designated Organizations (EU) NBR Brazilian National Standard NFPA National Fire Protection Association (US) NIOSH National Institute for Occupational Safety and Health (US) NP Portuguese Standard NRL Natural Rubber Latex NSC National Standards of Canada NTC Norma Técnica Colombiana (Colombian National Standard) NWSP Nonwovens Standard Procedure Organismo Nacional de Acreditación de Colombia (Colombian National ONAC Accreditation Body) OSH Occupational Safety and Health Law (Vietnam) OSHA Occupational Safety and Health Administration (US) PB Partial-body (protection) PPE Personal Protective Equipment PVC Polyvinyl Chloride 8 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets RPD Respiratory Protective Device RQL Rejectable Quality Level S Small (size) SABS South African Bureau of Standards SADC Southern African Development Community SADCMEL SADC Cooperation in Legal Metrology SADCSTAN SADC Cooperation in Standards SAHPRA South African Health Products Regulatory Authority SANS South African National Standard SCC Standards Council of Canada National System of Metrology, Standardization and Industrial Quality SINMETRO (Brazil) SIRIM Berhad (formerly the Standard and Industrial Research Institute of SIRIM Malaysia) SITRA South India Textile Research Association STAMEQ Directorate for Standards, Metrology and Quality (Vietnam) TBT (WTO) Technical Barriers to Trade Agreement TCVN Vietnam National Standard TGA Therapeutic Goods Administration (Australia) TPD Therapeutic Products Directorate (Canada) UK United Kingdom of Great Britain and Northern Ireland UKAS United Kingdom Accreditation Service UKCA United Kingdom Conformity Assessed marking UKNI United Kingdom Northern Ireland marking UNE Spanish National Standards Body US United States WHO World Health Organization WTO World Trade Organization XL Extra-Large (size) National Pharmaceutical Industry Standard of the People’s Republic of YY/T China 9 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets ACKNOWLEDGEMENTS This report was produced under IFC’s Global PPE Advisory Program, in partnership with the UK government. The program supports select manufacturers in emerging markets to develop their manufacturing capacity and supports governments and industry associations in select emerging markets to improve their knowledge and awareness on PPE quality and standards. The preparation of this publication was led by Nigel H Croft (Lead Consultant, BSI) and George Bamopoulos (PPE Lab Capacity Development Lead, BSI). The IFC and BSI team that oversaw and contributed to this publication consisted of Majda Stoshikj (Lead Project Manager, BSI), Sumit Manchanda (Senior Operations Officer, IFC), Bin Zhai (Associate Operations Officer, IFC), Anil Jauhri (Consultant, IFC) and Brendon Mendonca (Consultant, IFC). The team would like to thank Wafa Aranki (former Senior Operations Officer, IFC), Sabine Hertveldt (Senior Operations Officer, IFC), Tania Lozansky (Senior Manager, IFC), Cindy Parokkil (former Project Manager, International Projects, BSI), Nahyun Kim (Project Manager, International Projects, BSI), Mohammad Shohaieb (Principal Consultant, International Projects, BSI), Nathan Shipley (PPE Group Certification & Laboratory Manager, BSI), Graham Clements (former Certification Manager PPE, BSI), Ahmad Al-Khatib (Assurance Business Development and Acting System Certification Director, BSI), and Volodymyr Yakubov (Business Development Director, International Projects, BSI), for their excellent guidance, suggestions and contributions. The team is grateful for inputs, guidance, comments and feedback received from the colleagues and peer reviewers from other organizations. We would particularly like to thank Jose Sanez (Gerber Technology), Karen Batt (Standards Australia), James Galloway (JAS-ANZ), Raul Casanova (ABNT), Nelson Al Assal Filho (ABNT), Ricardo Fragoso (ABNT), Leonardo Machado Rocha (Inmetro), Bruce Farquhar (SCC), Luisa Pallares (ICONTEC), Subramaniam Sivakumar (SITRA), Ruba Al-Thawabeia (JSMO), Abeer Alzhair (JSMO), Qais Azzam (JSMO), Oyoo T. Otieno (KEBS), Bernard Njiraini (KEBS), Ngari Esther (KEBS), Martin Chesire (KENAS), Vivek Ramchandani (Hela Clothing), Feris Frederick (Standards Malaysia), Shaharul Sadri Alwi (Standards Malaysia), Hussalmizzar Hussain (Standards Malaysia), Norhaliza Binti Arifin (Standards Malaysia), Anuratha Sivam (Standards Malaysia), Atikah Binti Aman (Standards Malaysia), Nur Hadaina binti Hamdan (Standards Malaysia), Sadhvir Bissoon (SABS), Elsie Meintjies (UNIDO), Jeffrey O. Stull (International Personnel Protection, Inc.), Jeff Grove (ASTM International), Teresa Cendrowska (ASTM International), and Le Thi Thuy Hang (Quatest 1, Vietnam). The report was funded with UK Aid from the UK government, and the team would like to thank Kerry Conway (Head of Manufacturing, FCDO) and Grace Cramer (Manufacturing Africa Advisor, FCDO) for their support and guidance. 10 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets FOREWORD The COVID-19 pandemic has had a profound impact on the dynamics of global supply chains for personal protective equipment (PPE). It necessitated an urgent review and, in some cases, a temporary relaxation of the regulatory requirements and technical specifications in certain markets to ensure the ongoing availability of PPE for health care workers and front-line workers. In parallel, on the supply side, many non-traditional manufacturers ramped up their production capabilities, with some even manufacturing PPE for the first time to help cope with demand. This has meant that they have had to navigate their way through the many different market requirements to ensure compliance with the relevant standards and technical regulations. These requirements are often similar but not identical, and specify varying test methods and conformity assessment procedures. By producing this technical benchmarking guide, the International Finance Corporation (IFC) in partnership with the British Standards Institution (BSI) aim to fill a critical knowledge gap on technical regulations and standards for PPE. We hope the guide will also be useful for purchasing organizations on the demand side to better understand the required technical regulations and standards for PPE. This in turn will lead to better informed PPE product orders and help procurement agencies identify potential new suppliers from countries that are starting or expanding their PPE production in recent years. The guide presents the often complex and sometimes conflicting technical regulations, product standards and conformity assessment criteria in a simple way. It is intended to help manufacturers identify the realities of potential new markets and to act as a starting point for them to delve deeper into the specific product requirements and test methods by consulting the relevant standards and technical regulations as necessary. By using the two best-known markets, the European Union (EU) and the United States (US), as reference points, it is expected that manufacturers and purchasers alike will benefit from the comparisons that are made using a simple system of color coding, supported by more detailed analysis of the relevant standards. Initially focusing on 13 key markets, the modular design of the guide can facilitate the addition of other markets over time. Although there is still a paucity of standards and regulations related to sustainability, circularity, and inclusivity and gender-related “fit” requirements for PPE, users of the guide are alerted to the need for these aspects to be taken into account, as referenced in Annex A to this guide. In 2021 and 2022, IFC put the spotlight on the need to move away from plastics-based, single-use, disposable PPE toward more sustainable PPE products and business models through IFC’s publication “Innovation in Manufacturing Personal Protective Equipment—Toward Sustainability and Circularity.” In November 2021, IFC also convened stakeholders to discuss how PPE procurement and manufacturing can move away from “one size fits all” to cater to specific needs of female and male health care workers with a wider range of products and sizes that fit different body types. Both areas—sustainability and inclusivity/gender—are at the forefront of international attention and represent new opportunities for PPE production and procurement. Standards institutions and governments are expected to develop new technical standards and requirements in both areas. The guide is part of broader efforts by IFC and others to support global supply chains for PPE and to provide manufacturers and governments with a tool to expand the manufacturing and supply of PPE that is “fit for purpose”, that adequately protects all healthcare workers and is produced without harming the environment. Tania Lozansky, IFC Senior Manager, Manufacturing, Agriculture and Services. Scott Steedman, BSI Director of Standards 11 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 1 GENERAL 1.1 Background The COVID-19 pandemic increased demand across the world for medical personal protective equipment (PPE) which, coupled with disruptions in supply chains and the high concentration of PPE manufacturers in only a few countries, led to widespread shortages globally. Global demand for medical PPE is expected to remain significant for the foreseeable future, particularly as new variants of the virus or new viruses emerge. In support of the International Finance Corporation’s (IFC) Global Health Platform, IFC launched a Global Advisory Program on PPE in 2020, with funding and support from the UK government’s Foreign, Commonwealth and Development Office (FCDO). The program’s main objective is to support the diversification of global supply chains for PPE and to work with manufacturers and governments in developing countries to increase the manufacturing and supply of quality PPE in those countries. One critical knowledge gap was a guide that compares technical regulations and standards for PPE across countries. 1.2 Guide objectives and limitations This technical benchmarking guide forms a key part of IFC’s Global Advisory Program and provides manufacturers and purchasers with a tool to navigate through the technical regulations, product specifications and conformity assessment requirements associated with selected markets around the world. The guide focuses on medical PPE, excluding protective equipment and professional workwear to protect workers in other industries, outside health care. Overall, the guide seeks to simplify comparisons between the various COVID-19-related PPE categories and markets by using a system of color coding to highlight similarities and differences. For those who need more detail, it also takes a deeper dive into the technical regulations, product standards, and testing criteria for each PPE/market combination. Making these comparisons is a complex process due to: • The different regulatory approaches and relationships between (mandatory) technical regulations and (voluntary) standards used in different markets • The different technical regulations associated with PPE and medical devices, with some PPE categories needing to meet one or both sets of regulations simultaneously • International standards that are evolving quickly to cater to the needs of a rapidly changing PPE landscape but for which the latest versions are not always adopted at a national level or referred to in legislation. This time-lag in adoption can mean that the relevant standard might not be the latest version • The different testing methods that are required to demonstrate conformity to the various product standards. This can mean that although a specific category of PPE might be manufactured to meet the requirements of multiple markets, it has to undergo testing using different laboratory methods, approaches, or acceptance criteria. These are often expressed in different units of measurement, for which a direct comparison of results is impossible. It is for these reasons that the information provided in this guide should be used with caution. The guide is intended to be informative and a useful tool that provides a starting point for a more detailed analysis of the specific market requirements for each category of PPE. It should not be used as a substitute for consulting the latest versions of applicable legislation, technical regulations, product standards, and conformity assessment procedures or seeking expert advice, as needed. 12 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 1.3 How to use the guide The guide is split into sections from which the user can choose the relevant areas to access according to their needs: • Part 1: Introduction and the technical criteria for the various PPE categories in selected markets • Part 2: Generic descriptions of the main technical features for each PPE product category and associated standards for the selected markets • Part 3: Market-specific information, including an overview of each market and generic information about the regulatory environment, approaches to standardization, and conformity assessment • Part 4: Detailed comparisons of the technical requirements for the EU and US markets. International Organization for Standardization (ISO) product standards are also included where available • Parts 5–15: Detailed fact sheets with comparisons (benchmarking) of the specific requirements for each product/market combination against the reference EU/US market requirements • Annex A: Other considerations for manufacturers and purchasers to take into account, including sustainability and diversity/inclusivity (gender) issues, and approaches to conformity assessment and accreditation. Figure 1.1 shows the architecture of the guide. Figure 1.1: Schematic diagram showing the overall architecture of the guide General (Part 1) Legend: Detailed comparison of US Part 2 Part 4 Part 3 and EU markets for each product category (Product requirements and test methods) MASKS EUROPE MARKET 1 Generic Generic information for GLOVES MARKET 2 information on each PPE product destination market category EYE AND Overview FACE Overview (Typical product US MARKET 3 (Regulatory landscape; PROTECTION description, approach to characteristics and test standardization and methods) conformity assessment) Parts 5–15 Reference Legend: CLOTHING markets MARKET Legend: Comparison of destination market Detailed analysis of (EU/US) “n” product requirements product requirements (for each product and test methods for category) with EU EU and US markets and US as reference; overview only of test methods) Annex A: Additional considerations for manufacturers and purchasers of COVID-19-related PPE 13 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 1.4 Products covered by the guide • Masks • Respirators • Medical face masks • Community face coverings • Eye and face protection • Protective goggles/glasses • Face shields • Gloves • Medical examination gloves • Surgical gloves • Clothing • Full-body garments (including protective suits and coveralls) and partial-body garments (including aprons and shoe/head covers) • Gowns (including isolation and surgical gowns) Part 2 of this guide provides a description of the main characteristics and technical requirements related to the above categories of PPE, used in the context of the COVID-19 pandemic. 1.4.1 Classification: PPE or medical device? PPE and medical devices—key differences in the context of COVID-19 Definitions vary around the world but put simply: • PPE protects the wearer from a hazard. • Medical devices are for the prevention of patient disease or maintaining the clinical integrity of a procedure. Some products can serve both purposes. It is important to emphasize that this guide focuses on PPE as defined above and only considers medical devices, also as defined above, in cases where they can have a dual purpose of also protecting the wearer. The regulatory distinction between “PPE” and “medical devices” has implications not only in terms of the requirements to be met for placing products in specific markets but also regarding the applicable standards. Table 1.1 shows examples within the European context, but similar criteria also apply to most other markets. It is not always immediately clear whether certain categories of product are covered by PPE or medical device regulations (or both). Much depends on the manufacturer’s claims about the product, which are key to determining the applicable requirements in any jurisdiction. 14 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets An example in Table 1.1 would be a manufacturer of surgical gowns (usually classified as medical devices) that also claims that the gowns protect the wearer from infective agents (in which case they would also fall under the PPE regulations). Table 1.1: Examples of European regulations and standards related to PPE and medical devices PPE Medical device Regulation Regulation (EU) 2016/425 on personal Regulation (EU) 2017/745 on medical devices protective equipment (the PPE Regulation) (the MDR). The regulation has applied since covers the design, manufacture, and May 26, 2021. marketing of PPE. It defines legal obligations to ensure that PPE on the EU internal market Manufacturers must comply with the provide the highest level of protection against regulation when placing new medical devices risks. on the market. It repeals Directive 93/42/EEC on medical devices. Table 1.2: Examples of applicable standards EN 149:2001+A1:2009 Respiratory protective EN 14683:2019 Medical face masks— devices—filtering half-masks to protect requirements and test methods against particles—requirements, testing, marking EN ISO 374-5:2016 Protective gloves against EN 455-3:2015 Medical gloves for single use— dangerous chemicals and micro-organisms Part 3: Requirements and testing for biological evaluation EN 14126:2003 Protective clothing— EN 13795-1:2019 Surgical clothing and drapes— performance requirements and test methods requirements and test methods— for protective clothing against infective Part 1: Surgical drapes and gowns agents It is generally accepted good regulatory practice for technical regulations to specify “essential requirements” (usually based on generic performance criteria) while the technical details such as material performance characteristics, test methods, and so on are contained in (voluntary) standards. If a product conforms to the pertinent standard (called “harmonized standard” in the EU) then it is assumed that it fulfils the essential requirements (presumption of conformity). This approach allows for technical progress to be accommodated through amendments or new editions of standards, while the technical regulation itself remains relatively stable. In some other situations, voluntary standards can become compulsory when directly referenced in the regulations. Typically, this means that regulations might refer to a wide range of PPE and medical devices, only some of which are relevant for COVID-19-related applications. This can be seen schematically in Figure 1.2. 15 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Figure 1.2: Schematic representation of the interactions between PPE and medical devices PPE Medical Devices Include • Masks • Eye protection • Gloves Medical device regulations typically cover • Clothing a wide range of products, (Covered by this guide) many of which are not applicable to the COVID-19 context and are NOT But PPE regulations covered by this guide: also cover a wide range of products that are not • Pacemakers applicable to the COVID-19 scenario and are NOT cov- • Cardiovascular stents ered by this guide: • Breast implants • Hard hats • Tongue depressors • General work gloves • Elastic bandages • Ear protectors • Safety boots • Life jackets COVID-19-related PPE * Might be classified as PPE, with potential dual use* medical device, or both, depending on the specific • Masks application • Gloves • Clothing 1.4.2 Classification of products covered by this guide Masks: • Medical devices if they are used for the prevention of patient disease or maintaining the clinical integrity of a procedure, and do not have a tight seal on the face (for example, “surgical masks”) • PPE if they protect the wearer from infectious agents generated by the patient or the medical environment, or from exposure to harmful substances (for example, “respirators”) • Some masks may be dual purpose and perform both functions. Valved masks without exhalation filters generally are not considered to be medical devices. Eye and face protection: • In most countries, eye and face protection will be considered as PPE—it is primarily worn to protect the wearers’ eyes and face from liquid droplets or splashes, but can also be used for infection control purposes. Gloves: • Medical devices if they are for the prevention of patient disease or maintaining the clinical integrity of a procedure (for example, surgical and examination gloves) • PPE if they protect the wearer from infectious agents generated by the patient or the medical environment, or from exposure to harmful substances (for example, protective gloves) • Gloves may be dual purpose and perform both functions. 16 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Clothing: • Medical devices if they are for the prevention of patient disease or maintaining the clinical integrity of a procedure • PPE if it is to protect the wearer from infectious agents generated by the patient or the medical environment, or from exposure to related harmful substances (for example, harsh disinfectants or dangerous drugs) • Gowns and garments may be dual purpose and perform both functions. Figure 1.3 shows some of the guidance provided by the US Center for Disease Control (CDC) for COVID-19 situations where all these generic categories of PPE are used simultaneously. Figure 1.3: Use of PPE when caring for patients with confirmed/suspected COVID-19 17 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 1.5 Markets covered by the guide This guide has focused initially on the following 13 countries/regions, which are from the largest markets for health care-related PPE (see Figure 1.4), with North America and Europe alone comprising 55 percent (in value) of the total global market. • Australia • Brazil • Canada • Colombia • EU • India • Jordan • Kenya • Malaysia • South Africa • UK • United States • Vietnam These countries and regions were selected to provide a cross-section of the global market based on their size and geographical distribution. The availability of data on technical regulations and standards from the respective standardization bodies and regulatory authorities also played an important role. The modular nature of this guide means that additional markets can be added over time, as well as updates to the information provided. Figure 1.4: Health care-related PPE market share by region (2019)1 Europe North America 22% Asia and the Pacific 33% 28% Middle East and Africa 6% Latin America 11% 1 December 2020 (updated March 2021). COVID-19 – PPE Demand and Supply Perspectives. Final report. UK Aid. Source: Mordor Intelligence (updated in November 2020), Asian Development Bank 18 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 1.5.1 Approaches to standards and technical regulations Nowadays, most developed and many developing economies have similar conceptual approaches to the ways in which technical regulations relate to or depend on national, regional, or international standards. But there are still important differences in the details from one country to another. These are explained in more detail in Part 3 of the guide. ISO/IEC Guide 22 defines a standard as a “document, established by consensus and approved by a recognized body that provides, for common and repeated use, rules, guidelines, or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.” It goes on to say that “standards should be based on the consolidated results of science, technology and experience, and aimed at the promotion of optimum community benefit.” Standards encode knowledge regarding usability, quality, safety, performance, or any other characteristics required by users, into technical specifications for products, services, processes, and systems, as well as guidance on best practices. In the context of the World Trade Organization (WTO) Technical Barriers to Trade (TBT) Agreement (which in principle applies to most international transactions for the PPE covered by this guide), the term “standard” is defined slightly differently than in ISO/IEC Guide 2, as follows: “Document approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory.” The relation between (voluntary) standards and (mandatory) technical regulations is defined in Article 2.4 of the TBT agreement: “Where technical regulations are required and relevant international standards exist or their completion is imminent, members shall use them, or the relevant parts of them, as a basis for their technical regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued, for instance, because of fundamental climatic or geographical factors or fundamental technological problems.” It is also important to recognize that, although the WTO/TBT model emphasizes the need to separate the “voluntary” nature of standards from the “compulsory” nature of technical regulations, this is not always the current reality. This is particularly true in some developing countries and transition economies, where certain standards are viewed as being compulsory and continue to be used as de facto technical regulations. For manufacturers and purchasers of PPE, the main categories of standards that are most relevant are the following: Product standards that provide information (usually in the form of requirements) regarding the materials, processing methods, and acceptance criteria for specific categories of PPE. Some standards apply to a range of products, while others can be specific to a product or material. Prescribed test methods by which conformity to the product standards can be demonstrated Quality management system standards (such as ISO 90013) that apply to manufacturers of PPE and are aimed at providing confidence in the supplier’s “ability to consistently provide products that meet customer and applicable statutory/regulatory requirement.” For producers of medical devices (including some PPE with a dual function—see 1.4.1) the requirements are defined in ISO 13485.4 Conformity assessment standards (such as ISO/IEC 17025 for laboratories,5 ISO/IEC 17020 for inspection bodies,6 ISO/IEC 17021-1 for management system certification bodies7, and ISO/IEC 17065 for product 2 ISO/IEC Guide 2. 2004. Standardization and Related Activities—General Vocabulary. 3 ISO 9001. 2015. “Quality management systems—requirements.” 4 ISO 13485. 2016. “Medical devices—quality management systems—requirements for regulatory purposes.” 5 ISO/IEC 17025. 2017. “General requirements for the competence of testing and calibration laboratories.” 6 ISO/IEC 17020. 2012. “Conformity assessment—requirements for the operation of various types of bodies performing inspection.” 7 ISO/IEC 17021-1. 2015. “Conformity assessment—requirements for bodies providing audit and certification of management systems.” 19 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets certification bodies8) that are used as a basis for accreditation of conformity assessment bodies. For the PPE covered in this guide, most developed countries adopt (to a greater or lesser extent) the principle of “presumption of conformity” by which demonstrated conformity to the (voluntary) standards mentioned is accepted as evidence of conformity to the relevant technical regulation. This is described further in Part 3 of the guide. 1.5.2 Key standards for PPE in the markets covered by this guide The standards that apply in the EU and US markets are undoubtedly the best-known to most exporters and potential exporters from developing economies and are the ones most commonly adopted or referred to in those countries. For those reasons, they are used as a reference throughout this guide, against which the requirements of the other markets can be compared and benchmarked. Although there is a tendency (and an inherent preference as stated in the WTO/TBT Agreement) to use international standards as a basis for demonstrations of conformity to technical regulations, regulatory agencies in the various markets typically reference the relevant national or regional standards. These may or may not be national adoptions of regional or international standards. Part 2 of the guide provides a high- level overview in which readers can see where there are similarities in the approach and the core standards used in different countries. In Europe, “EN” standards are issued by the European Committee for Standardization (CEN) and are formally adopted by the various member states as, for example, “DIN EN 149” (in Germany) or “UNE EN 455-1” in Spain, and so on. In a number of cases, the EN standards are themselves adoptions of standards published by the ISO, meaning that their contents are essentially identical. These are identified by the prefix “EN ISO” or, in the case of National Standards, NP EN ISO 9001 (in Portugal, for example). In the United States, different standards development organizations are recognized (accredited) by the American National Standards Institute (ANSI) to publish national standards. In the context of PPE, the prevalent standards development organization is ASTM International (formerly known as the American Society for Testing of Materials), many of whose standards have a global reach and are also adopted as national standards in some economies. In other economies and markets, there is typically only one national standards body, which may use one (or a combination) of the following options for the standards it develops and publishes: • National adoption of an ISO standard. This can be identical (thereby facilitating the benchmarking process) or similar/technically equivalent (where national modifications are made) • National adoption of an EN standard (typically applicable when there is no ISO equivalent) • National adoption of other relevant standards such as those developed by ASTM • Independent (standalone) national standard that has been developed locally. Examples of national standards bodies include the BSI, Associação Brasileira de Normas Técnicas (ABNT), and Standards Council of Canada (SCC). Part 3 of this guide presents further details for each of the markets considered. 1.5.3 Overall regulatory approaches for PPE Standards and product testing are typically used to underpin regulatory requirements for PPE and their associated attestations of product conformity as follows: • Regional mandatory product certification schemes such as those requiring CE Marking (EU Mark of Conformity) in the EU • National mandatory product certification schemes such as that of the National Institute for Occupational Safety and Health (NIOSH) in the United States 8 ISO/IEC 17065. 2012. “Conformity assessment—requirements for bodies certifying products, processes and services.” 20 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets • Voluntary product certification through an accredited body, which may or may not be directly mandated as part of the individual standard (for example, Underwriters’ Laboratories third-party certification of emergency medical protective clothing, applied globally where claims are made for compliance). The summary of requirements shown in Table 1.3 is adapted from the WHO publication “Technical Specifications for Personal Protective Equipment for COVID-19—Interim Guidance 13 November 2020.”9 It is important to note that, due to limited manufacturing capacity, some products might come from other economic regions or might have “emergency use authorizations” by regulatory agencies. Therefore, the requirements listed below might apply only for a limited period during the COVID-19 pandemic and are likely to be updated. Some differences in the specific scope and details of the requirements may well exist at a national level where these temporary allowances are made. 9 https://www.who.int/publications/i/item/WHO-2019-nCoV-PPE_specifications-2020.1. 21 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 1.3: Summary of requirements for COVID-19-related PPE Topic Requirements General technical According to the technical specifications of PPE specific for COVID-19 requirements Labeling on the primary packaging needs to include: • Name and/or trademark of the manufacturer Primary packaging • Model or product reference • Information for particular storage conditions (temperature, pressure, light, humidity) • General quality management (for example, ISO 9001), for non-medical devices Quality management • EU Module C2 or D conformity to type certificate (Category III PPE only) system from the manufacturer, for the • Certified quality management system for medical devices (for example, ISO 13485) PPE types and application of risk management to medical devices (for example, ISO 1497110), if applicable. Free sales certificate of medical device and related infection prevention and control products. Certificate for exportation of medical device and related infection prevention and control products, provided by the authority in manufacturing country (in case of imported goods). National local regulatory approval (of recipient country, as applicable). Proof of regulatory compliance, as appropriate, per the product’s risk classification, for example, Regulatory approval/ • Europe: CE marking and declaration of conformity and/or EU type examination certification11 certificate as applicable, for example, PPE Category III for respirators • US Food and Drug Administration (FDA) approval, emergency use authorization, or temporary enforcement policy. Ability for purchaser to check authenticity directly with the issuing regulatory authority (for example, online database of active licenses). Category I PPE may accept self-declaration with declaration of conformity (COVID-19 context). Authorized representative must be identified and document expiration date (valid until …). Official test reports (all pages, in English) must either originate from test laboratories accredited to ISO/IEC 17025, preferably by a signatory of the International Laboratory Accreditation Cooperation (ILAC) mutual recognition arrangement (MRA) or from an EU notified body. Test reports should clearly indicate the accredited laboratory name and accreditation (for regulators or purchasers to be able to check the authenticity of test reports). Test reports Test standard must be within the accreditation scope of the laboratory. EU-type examination certificates for category III PPE should mention the notified body name/number. Instructions for authentication of the test report(s) and certificates should be provided. Ability for purchaser to check authenticity directly with the accredited test laboratory (for example, online uploading of test report and automatic version check, or emailing the test facility). 10 ISO 14971:2019. “Medical devices—application of risk management to medical devices.” 11 Note: Regulatory approval or compliance may not always require formal certification. 22 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 1.6 Guidance for purchasers of COVID-19-related PPE In order for purchasers (governments, health care organizations, distributors of medical consumables and/ or purchasing agents) to have confidence in the PPE they are buying, they need be aware of the following recommendations: • Check any applicable regulations for the specific PPE you are purchasing. Although it is the legal obligation of suppliers to ensure that the PPE meets all applicable regulatory requirements, they might not always be familiar with the requirements of your particular market. Establish a dialogue with the supplier before agreeing to any contract. • Specify clearly what it is that you want to buy, including any regulatory requirements (for example, related to PPE or medical device regulations in your country) and (where possible) the relevant standards and test methods that are applicable (including the appropriate revision dates). You might want to agree on any alternatives that might be acceptable to regulators in your country (for example, PPE that meets foreign regulations)—possibly on a temporary/emergency basis. See section 1.5.3. • Selection of suppliers can include the following considerations: • Using your traditional manufacturers, importers and distributors where you already have confidence in their ability to meet your requirements • Recommendations from reputable purchasers in other markets, based on the supply of similar products • The manufacturer’s accredited certification to a recognized quality management system standard such as ISO 9001 or, in the case of PPE that is also classified as a medical device, ISO 13485. Check the validity date on any certificates and that their scope covers the PPE categories that are being purchased • If the PPE you are purchasing is not covered by regulations in your country, it may be prudent to request the supplier to provide evidence of regulatory approval in another country, or accredited certifications to recognized (preferably international) standards. • Verify any claims by suppliers that they are “approved” or “certified.” During the COVID-19 pandemic there have been false or fraudulent claims made of conformity to technical regulations and specific product or quality management system standards such as those mentioned in this guide. This verification process can be quite complex, as explained below, but it should avoid unpleasant surprises for purchasers. Ironically, the more seals, stamps, and marks are shown on a certificate, the more likely it is to have been falsified. • The only claims of conformity to product or quality management system standards that you can trust are those that are supported by a certificate issued by a recognized certification body. This typically means that the certification body has been officially recognized by your government or ACCREDITED by an accreditation body that is in turn listed on the International Accreditation Forum (IAF) website as a signatory to the IAF Multilateral Recognition Arrangement (MLA- see Annex A3). Such certificates will typically (but not always) bear the following mark: If in doubt, or if the IAF logo does not appear, the certificate will show the logo and an identification number of the issuing certification body’s accreditation body (for example, ANAB, UKAS, DAkkS, and so on). You can consult the certification body that issued the certificate to confirm its validity and the accreditation body to ensure that the certification body is duly accredited as competent to issue the certification. All accreditation bodies have searchable databases on their websites to provide this information on accredited certification bodies. All accredited certification bodies under the IAF framework are obliged 23 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets to provide verification of certificates issued by them. In addition, the IAF has established a centralized database of certificates at https://www.iafcertsearch.org/ in which participation is voluntary. All certificates mentioned in this database can be trusted, but their absence does not necessarily mean the certificate is not authentic. However, the logo of the accreditation body belonging to the IAF’s system is a must for a certificate to be credible. Some PPE may necessitate the use of independent “notified bodies” (or equivalent designations) to demonstrate product conformity. Such bodies are typically “designated” by the regulators in each country or region (see, for example, section 3.1.3). It is essential to verify from the website of the regulator that the notified body issuing the attestations of conformity has been duly designated. It has been found that some certification bodies, which are not designated by the regulators, have been issuing certificates for conformity to technical regulations, such as those that form the basis for applying the EU’s CE mark. • Ensure that any test reports or certificates used to support supplier claims of conformity are issued by a laboratory that is recognized by your government, or ACCREDITED to ISO/IEC 17025 by an accreditation body that is listed on the ILAC website as being a signatory to the ILAC Mutual Recognition Arrangement (MRA). Such certificates will typically (but not always) bear the following mark: If in doubt, or where the ILAC logo does not appear, the test report or certificate will show the logo and an identification number of the issuing test laboratory’s accreditation body (for example, ANAB, UKAS, and DAkkS). You can consult the test laboratory that issued the test report or certificate to confirm its validity, and the accreditation body to ensure that the test laboratory is duly accredited as competent to carry out the testing (and that the tests performed are within the published scope of their accreditation). All such accreditation bodies are required to have searchable databases to provide this information. Where a test report does not show an accreditation mark, or if the tests are not within the accreditation scope of the test laboratory, the purchaser should proceed with caution. It might still be possible to accept the test report, but in this case the purchaser should contact the laboratory to determine the competence of the laboratory to conduct such tests. Remember, regardless of the logos that appear on a certificate, it is always prudent to check the issuer’s accreditation status using the following steps: • Start by consulting the ILAC or IAF website • Select the appropriate economy (country) • Consult the listed accreditation body (bodies) within that economy • Locate the laboratory or other conformity assessment body on the accreditation body’s website and check the scope and validity of their accreditation • Depending on the level of confidence they have in the supplier, it may be appropriate for large purchasers to consider subcontracting accredited inspection agencies to conduct independent pre-shipment inspections • Large purchasers with ongoing contracts with specific suppliers may also find it prudent to undertake their own market surveillance of the PPE they have purchased, by making random checks on quality by testing product samples in an accredited laboratory • If any problems are encountered with purchased PPE (and in particular regarding its conformity to technical regulations) it is important to provide feedback to the relevant regulators so they can take appropriate actions and make this information available to others. 24 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 2 OVERVIEW OF PRODUCT CATEGORIES This part of the guide provides a generic description of each category of COVID-19-related PPE, and a high-level overview of the standards used in each of the selected markets. More detailed descriptions and comparisons are provided later in Parts 4 and 5–15 of this guide. Table 2.1 shows at a macro level where national product standards are based on or are similar to versions of other national, regional, or international standards. Links are provided for users to access the detailed information provided in the remainder of Part 2 and in Part 3. Users are advised to use caution with the comparisons provided throughout Part 2, which necessarily simplify the complex nature of the relationships between the various standards. The reasons for this are explained in more detail in section 1.2 of the guide. Table 2.1: High-level overview of the basis for PPE standards in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard Link to product details 3.12 3.10 n/a 3.13 3.11 3.4 3.6 3.9 3.8 3.2 3.5 3.3 3.7 3.1 United States Link to market overview South Africa Colombia Australia Malaysia Vietnam Canada Jordan Kenya Brazil India UK ISO EU Respirators 2.1.1 Medical face masks 2.1.2 Community face coverings 2.1.3 Face shields 2.2.1 Protective goggles/glasses 2.2.2 Medical examination gloves 2.3.1 25 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Link to product details 3.12 3.10 n/a 3.13 3.11 3.4 3.6 3.9 3.8 3.2 3.5 3.3 3.7 3.1 United States Link to market overview South Africa Colombia Australia Malaysia Vietnam Canada Jordan Kenya Brazil India UK ISO EU Surgical gloves 2.3.2 Suits and coveralls 2.4.1.1 Aprons 2.4.1.2 Shoe and head covers 2.4.1.2 Gowns 2.4.2 Notes: • In some cases, the market standard mentioned is based on older versions of the EU/US/ISO standard, meaning there may no longer be any equivalence. • Standards from other countries or regions may be accepted by the relevant authorities in specific markets. These are not included here. • In some cases, two colors are used to indicate that two product standards are recognized for those product/market combinations. • Users are referred to the relevant parts of the guide for more detailed information (including testing standards). 2.1 Masks Masks are generally items worn by the individual on their face which offer protection from the inhalation of hazardous substances. They act as a form of source control to limit the transmission of respiratory aerosols, or both. There are three main types of masks that are used as PPE in the COVID-19 context: respirators, medical face masks and community face coverings (sometimes called barrier face coverings). Respirators can include single-use or reusable half-masks or full-face masks that have replaceable filters. 26 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Figure 2.1: The three main categories of disposable masks Note: Clause numbers refer to ASTM F3502-21 for barrier face coverings. Source: ASTM International Figure 2.2: Typical reusable half- and full-mask respirators12 2.1.1 Respirators Respirators (respiratory protective equipment or filtering facepiece respirators)13 are considered to be PPE and are normally regulated as such, though in some jurisdictions they are also considered as medical devices. They fit the face tightly and provide certain filtration efficiency levels to help reduce wearer exposure to pathogenic airborne particles in a health care or related exposure setting. They use filters to remove contaminants from the air being breathed in and are thus designed to protect the wearer from breathing harmful substances. 12 https://www.fit2fit.org/wp-content/uploads/2021/04/Essential_technical_specifications_PPE_and_medical_devices-v0.3_ Oct2020_accessible.pdf 13 For detailed definitions, see ISO 16972: 2020. “Respiratory protective devices—vocabulary and graphical symbols.” 27 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Respirators can be either: • Non-powered—relying on the wearer’s breathing to draw air through the filter • Powered—using a motor to pass air through the filter to give a supply of clean air, for example, powered air-purifying respirator. Note: In the context of the COVID-19 pandemic, this benchmarking guide focuses only on disposable/reusable non-powered respirators. A key component of any respirator is the filter. This can be an integral part of a disposable device or come separately so it can be changed on a reusable respirator. It is vital that the filter is effective against the hazard. For COVID-19 settings this will typically be a high-efficiency (P2) particle filter as defined in Europe or a minimum N95 as established in the United States, which will be suitable for respiratory protection during aerosol-generating procedures or other human activity such as breathing, talking and singing. Respirator filters, especially those used in disposable respirators, are typically made from three layers but can include additional layers: • Inner and outer layers of spunbond non-woven fabric • A middle layer of meltblown fabric Typical characteristics for respirators: • Fit • Carbon dioxide content • Total inward leakage • Breathing resistance (inhalation) • Filtration efficiency • Breathing resistance (exhalation) • Biocompatibility Table 2.2 provides an overview of the main national product standards for respirators in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 2.2: Overview of the standards for respirators in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) ISO 17420-1:2021 Respiratory protective devices (RPD)—performance requirements— ISO standards Part 1: General  (for 4.1.1.3 comparison) ISO 17420-2:2021 Respiratory protective devices—performance requirements—Part 2: Requirements for filtering RPD  EN 149:2001+A1:2009 RPD—filtering half-masks to protect against particles— requirements, testing, marking EU 4.1.1.1 EN 143:2021 Respiratory protective devices— particle filters—requirements, testing, marking 28 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets United States 42 CFR 84.170 Air-purifying particulate respirators 4.1.1.2 Australia AS/NZS 1712:2012 Respiratory protective devices 5.1.1 ABNT NBR 13698:2011 Respiratory protective devices—filtering half-mask to protect against particles. Based on EN 149:1992, since revised Brazil 6.1.1 ABNT NBR 13697:2010 Respiratory protective devices—particle filters. Based on EN 143:2000, since revised Canada CSA Z94.4:2018 Selection, use and care of respirators 7.1.1 NTC 3852:2020 Respiratory protective devices—filtering half-masks to protect against particles—requirements, testing, marking. Identical to EN 149:2001 +A1:2009 8.1.1 Colombia NTC 6486:2020 Respiratory protective devices. For N series respirators, adopts 42 CFR part 84 requirements IS 9473:2002 (reaffirmed 2019) Respiratory protective devices—filtering half-masks to 9.1.1 India protect against particles—specification. Based on EN 149:1991 version (since revised) JS 1943:2011 Respiratory protective devices—filtering half-masks to protect against Jordan 10.1.1 particles—requirements, testing, marking. Identical to EN 149:2001, since amended KS 2409-6:2018 Health care wastes management commodities. Specification–Part Kenya 6: Filtering face masks to protect against particles. Based on (but not identical to) EN 11.1.1 149:2001, since amended MS 2323:2010 Respiratory protective devices—filtering half-masks to protect against Malaysia 12.1.1 particles—requirements, testing, marking. Identical to EN 149:2001, since amended SANS 50149:2003 Respiratory protective devices—filtering half-masks to protect against particles—requirements, testing, marking. Identical to EN 149:2001, since South Africa amended 13.1.1 SANS 50143:2003 Respiratory protective devices - Particle filters - Requirements, testing, marking. Identical to EN 143:2000, since revised BS EN 149:2001 +A1:2009 RPD—filtering half-masks to protect against particles— requirements, testing, marking UK 14.1.1 BS EN 143:2021 Respiratory protective devices—particle filters—requirements, testing, marking Vietnam  n/a 15.1.1 2.1.2 Medical face masks This is a mask that covers the user’s nose and mouth primarily for the purposes of source control, that is, limiting the number of droplets that can be expelled from the wearer that can contaminate others. Medical face masks include surgical masks (having ties to allow adjustment) and procedure or isolation masks (having ear loops) which provide a physical barrier to fluids and particulate materials. The main intended use of medical face masks is to minimize transfer of infectious agents by large-particle droplets between health care staff and a patient during surgical procedures and other medical/health care settings with similar requirements. 29 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Although these are generally considered to be medical devices, they are often used as community masks, worn by patients and other persons to reduce the risk of spreading infections, particularly in epidemic or pandemic situations. The materials used for medical masks are typically the same as those for respirators—inner and outer layers of spunbond non-woven fabric with a middle layer of meltblown fabric that often has a lower filtration efficiency compared to those used in respirator filters. Typical characteristics for medical face masks: • Bacterial filtration efficiency (BFE) • Microbial cleanliness (bioburden) • Sub-micron particulate filtration • Biocompatibility efficiency using a different size • Breathability particle and test conditions than • Internal and external faces clearly used for respirators identified (sometimes by color) • Fluid (splash) resistance • Generally only provided in a single size Table 2.3 provides an overview of the main national product standards for medical face masks in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 2.3: Overview of the standards for medical face masks in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) ISO standards (for n/a - comparison) EU EN 14683:2019 Medical face masks—requirements and test methods 4.1.2.1 ASTM F2100-21 Standard specification for performance of materials used in medical United States 4.1.2.2 face masks Australia AS 4381:2015 Single-use face masks for use in health care 5.1.2 ABNT NBR 15052:2021 Masks for dental-medical-hospital use—requirements and Brazil 6.1.2 test methods Canada n/a 7.1.2 NTC 1733:2020 Medical face masks—requirements and test methods. Colombia 8.1.2 Identical to EN 14683:2019  NTC 6436:2020 Standard specification for performance of materials used in medical face masks. Identical to ASTM F2100-20, since revised IS 16289:2014 (reaffirmed 2019) Medical textiles—surgical face masks— India 9.1.2 specification  JS 1745:2007 Disposable surgical masks—requirement and test methods. Based on Jordan 10.1.2 EN 14683:2005, since revised 30 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets KS 2636:2021 Medical face masks—specification. Based on (but not identical to) EN Kenya 11.1.2 14683:2019 MS EN 14683:2021 Medical face masks—requirements and test methods. Malaysia 12.1.2 Identical to EN 14683:2019  SANS 1866-1:2018 Medical devices. Part 1: Medical face masks. Based on ASTM F2100, most recently revised in 2021 South Africa 13.1.2 SANS 1866-2:2018 Medical devices. Part 2: Medical respirators. Based on ASTM F2100 and 42 CFR part 84 UK BS EN 14683:2019 Medical face masks—requirements and test methods 14.1.2 TCVN 8389-1: 2010 Medical face mask. Part 1: Normal medical face mask Vietnam 15.1.2 TCVN 8389-2:2010 Medical face mask. Part 2: Medical face mask preventing bacteria 2.1.3 Community face coverings14 These are neither PPE (in the strict sense) nor medical devices. They are not usually subject to regulations other than those for general product safety. Community face coverings are Typical characteristics typically for made community from face one or multiple layers of fabric (woven, knitted or non- coverings: woven) with a means of attachment to the head or ears. • Covers wearer’s nose and mouth • Internal and external faces should be While• standards respirators and medical face masks pre-dated for breathability Offers good the clearly COVID-19 pandemic, it is only recently identified (in 2020 and 2021) that standards have • Has some level of filtration efficiencybeen developed for community • Can be single-useface reusable Some of these or coverings. country- or region-specific standards are discussed as established by a specific test (either in more detail later in this guide. • May be offered in different sizes particulate or bacterial) Table 2.4 provides an overview of the main national product standards for community face coverings in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 2.4: Overview of the standards for community face coverings in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) Relevant ISO standards  n/a - CWA 17553:2020 Community face coverings—guide to minimum 4.1.3.1 EU requirements, methods of testing and use  14 Sometimes referred to as “community face masks,” “barrier face coverings,” or (in everyday speech and by the media) as “face masks.” 31 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets ASTM F3502-21 Standard specification for barrier face coverings 4.1.3.2 United States AATCC M14 Guidance and considerations for general purpose textile face coverings Australia n/a 5.1.3 ABNT PR 1002:2020 Edition 2 Masks for non-professional respiratory 6.1.3 Brazil protection—guide with basic requirements for testing, manufacture and use BNQ 1922-900:2020 Masks intended for working environments— 7.1.3 Canada Attestation Document (for Province of Québec) NTC 6449:2020 Masks (face masks) for use in environments other than the 8.1.3 Colombia health sector India n/a 9.1.3 Jordan n/a (under development) 10.1.3 KS 2924:2020 Personal protective equipment—face masks—masks for 11.1.3 Kenya public use—specification Malaysia n/a 12.1.3 South Africa n/a (under development) 13.1.3 UK BSI Flex 5555:2021 Community face coverings—specification 14.1.3 Vietnam n/a 15.1.3 2.2 Eye and face protection15 Eye/face protection for COVID-19 settings is designed to protect the wearers’ eyes and face from splashes and droplets of biological fluids. The two main types of protection are protective glasses/goggles and face shields. 2.2.1 Protective goggles/glasses These are typically made with a flexible plastic frame and one or two lenses16 with a flexible elastic headband. They provide barrier protection to the eyes against exposure to liquid droplets and splashes. Protective goggles are distinguished from protective glasses in providing better coverage (protection) to the wearer’s face around the lens of the goggles, whereas protective glasses generally only provide direct (straight-on) and side protection. Protective goggles also come as different types which may have ventilation holes for the prevention of fogging. Typical characteristics for protective goggles/glasses: • Clear lens with anti-fog and scratch-resistant • Accommodate wearers with needs for treatments prescription lenses • Lenses are free from defects that could impair • Have adjustable band to secure firmly so as the wearer’s vision not to become loose during clinical activity • Easily fit face contours with even pressure • May include direct or indirect venting to • Enclose eyes and the surrounding areas (side avoid fogging shields only for protective glasses) • Provide impact resistance • May also shield from droplets/splashes 15 For detailed definitions, see ISO 4007: 2018, “Personal protective equipment—eye and face protection—vocabulary.” 16 For the purposes of eye and face protection, the word “lens” includes afocal lenses, corrective lenses, and prescription lenses. 32 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Figure 2.3: Safety glasses and non-ventilated goggles Table 2.5 provides an overview of the main national product standards for protective goggles/glasses in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 2.5: Overview of the standards for protective goggles/glasses in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) ISO standards (for ISO 16321-1:2021 Eye and face protection for occupational use—Part 1: General 4.2.3 comparison) requirements EU EN 166:2001 Personal eye-protection—specifications 4.2.1 ANSI/ISEA Z87.1-2020 Occupational and educational personal eye and face protection devices United States ANSI/ISEA Z87.62-2021 American national standard for occupational and 4.2.2 educational personal eye and face protection devices for preventing exposures caused by sprays or spurts of blood or body fluids AS/NZS 1337.1:2010 (+ AMDT 1:2012 + AMDT 2:2018) Personal eye-protection— Australia Part 1: Eye and face protectors for occupational applications. Based on (but not 5.2 identical to) EN 166 Brazil n/a (Legislation refers to ANSI Z87.1:2015) 6.2 CSA Z94.3-2020 (revised May 2021) Eye and face protectors Canada CSA Z94.3.1-2016 Guideline for selection, use, and care of eye and face 7.2 protectors  33 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets NTC 6493:2020 Individual eye protection. Specifications. Identical to EN Colombia 166:2001 8.2 NTC 3610:2020 Eye and face personal protection devices at work and education. Identical to ANSI/ISEA Z87.1: 2015, since revised IS 5983:1980 (reaffirmed 2018) Specification for eye protectors. Based on ISO India 9.2 4849, since replaced by ISO 16321-1  Jordan JS 268:2008 Personal eye-protection—specifications. Identical to EN 166:2001 10.2 KS 2409-8:2018 Health care wastes management commodities. Specification— Kenya 11.2 Part 8: Safety goggles. References ISO 4849, since replaced by ISO 16321-1 Malaysia n/a 12.2 SANS 50166:2002 Personal eye-protection—specifications. Identical to EN South Africa 166:2001 13.2 SANS 1404:2009 Eye-protectors for industrial and non-industrial use UK BS EN 166:2002 Personal eye-protection—specifications 14.2 Vietnam  n/a 15.2 2.2.2 Face shields These have one large visor with a frame and an adjustable head harness or are mounted on a helmet. Most can be worn with prescription glasses. They provide barrier protection against liquid splashes to the face but do not fully enclose the eyes. These products may be rugged and reusable or disposable in nature depending on their materials and design. Face shields may also be integrated into some types of medical masks as a disposable transparent layer that rises above the individual wearer’s nose. Typical characteristics of face shields: • Made of clear plastic and providing good • May be fog resistant (preferable) visibility to both the wearer and the patient • Completely cover the sides and length of • Potentially have adjustable band or headgear the face to attach firmly around the head and fit • May be reusable (made of robust material snugly against the forehead which can be cleaned and disinfected) or disposable Figure 2.4: Disposable and industrial face shields Disposable face shield Industrial face shield 34 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 2.6 provides an overview of the main national product standards for face shields in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 2.6: Overview of the standards for face shields in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) ISO standards ISO 16321-1:2021 Eye and face protection for occupational use—Part 1: General 4.2.3 (for comparison) requirements EU EN 166:2001 Personal eye-protection—specifications 4.2.1 ANSI/ISEA Z87.1:2020 American national standard for occupational and educational personal eye and face protection devices United States  ANSI/ISEA Z87.62-2021 American national standard for occupational and 4.2.2 educational personal eye and face protection devices for preventing exposures caused by sprays or spurts of blood or body fluids AS/NZS 1337.1:2010 (+ AMDT 1:2012 + AMDT 2:2018) Personal eye-protection— Australia Part 1: Eye and face protectors for occupational applications. Based on (but not 5.2 identical to) EN 166 ABNT PR 1009:2021 Face protection for health care applications—guide with basic Brazil 6.2 requirements for testing, manufacture, and use. Based on ANSI Z87.1:2015 CSA Z94.3-2020 (revised May 2021) Eye and face protectors Canada 7.2 CSA Z94.3.1-2016 Guideline for selection, use, and care of eye and face protectors Colombia NTC 6493:2020 Individual eye protection—specifications. Identical to EN 166:2001 NTC 3610:2020 Eye and face personal protection devices at work and education. 8.2 Identical to ANSI/ISEA Z87.1: 2015 IS 5983:1980 (reaffirmed 2018) Specification for eye protectors. Based on ISO 4849, since replaced by ISO 16321-1  India 9.2 IS 8521-1:1977 (reaffirmed 2018) Specification for industrial face shields—Part 1: With plastic visor Jordan JS 268:2008 Personal eye protection—specifications. Identical to EN 166:2001 10.2 Kenya KPAS 2919:2020 Personal protective equipment—face shield—specification 11.2 Malaysia n/a 12.2 SANS 50166:2002 Personal eye protection—specifications. Identical to EN South Africa 166:2001 13.2 SANS 1404:2009 Eye protectors for industrial and non-industrial use UK BS EN 166:2002 Personal eye protection—specifications  14.2 Vietnam n/a 15.2 35 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 2.3 Gloves Although different countries use slightly different names to describe the various kinds of gloves that are used as COVID-19-related PPE, the two main categories considered in this guide are medical examination gloves and surgical gloves, both for single use. The definition of medical gloves for single use given in the standard EN 455-117 is “gloves intended for use in the medical field to protect patient and user from cross- contamination; intended to be used on one individual during a single procedure.” 2.3.1 Medical examination gloves The standard EN 455-2 defines an examination glove (sometimes called a procedure glove) as a “sterile or non-sterile medical glove, which may or may not be anatomically shaped, intended for conducting medical examinations, diagnostic, and therapeutic procedures and for handling contaminated medical material.” These products are also a primary precaution for contact with any contaminated surfaces by the wearer. The gloves are generally very thin in order to fit intimately on the wearer’s hand and to have minimal impact on hand function. Medical examination gloves are typically produced as non-sterile, powder-free single-use gloves made from nitrile, latex, polychloroprene or PVC, with a total length that extends past the wearer’s wrists and thicknesses ranging from 0.05 mm to 0.25 mm. They are typically produced in sizes S (small), M (medium), or L (large) and often are of an ambidextrous design. Typical characteristics for medical examination gloves: • Provide freedom from holes • Often free of powder residue • Tensile properties for breaking strength and • Non-irritating for the skin elongation • Offered in multiple sizes and are ambidextrous Table 2.7 provides an overview of the main national product standards for medical examination gloves in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. 17 EN 455-1: 2020. “Medical gloves for single-use—Part 1: Requirements and testing for freedom from holes.” 36 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 2.7: Overview of the standards for medical examination gloves in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) ISO 11193-1:2020 Single-use medical examination gloves—Part 1: Specification for gloves made from rubber latex or rubber solution  ISO 11193-2:2006 Single-use medical examination gloves—Part 2: Specification ISO standards (for for gloves made from poly(vinyl chloride)  4.3.1.3 comparison) ISO 21420:2020 Protective gloves–general requirements and test methods ISO 374-5:2016 Protective gloves against dangerous chemicals and micro- organisms­ —requirements for micro-organisms risks EN 455 series (Medical gloves for single use)  EN 455-1: 2020 Requirements and testing for freedom from holes  EN 455-2: 2015 Requirements and testing for physical properties EN 455-3: 2015 Requirements and testing for biological evaluation  EU 4.3.1.1 EN 455-4: 2009 Requirements and testing for shelf-life determination EN ISO 21420:2020 Protective gloves­ —general requirements and test methods EN ISO 374-5: 2016 Protective gloves against dangerous chemicals and micro- organisms - Requirements for micro-organisms risks  ASTM D5250-19 Standard specification for poly(vinyl chloride) gloves for medical application  ASTM D6319-19 Standard specification for nitrile examination gloves for medical application ASTM D3578-19 Standard specification for rubber examination gloves United States 4.3.1.2 ASTM D6977-19 Standard specification for polychloroprene examination gloves Typical characteristics NFPA 1999 (2018) for medical Standard examination on protective gloves: clothing and ensembles for emergency medical operations freedom from • Provide ANSI/ISEA holes 105-2016 American national standard for hand protection • Tensile properties classificationfor breaking strength and elongation • Often free of powder residue AS/NZS 4011.1:2014 Single-use medical examination gloves–Part 1: Specification for gloves made from • Non-irritating for the skinrubber latex or rubber solution. Adopted with national modifications from ISO 11193-1:2008, since revised Australia • Offered in multiple sizes and are ambidextrous 5.3.1 AS/NZS 4011.2:2014 Single-use medical examination gloves­ —Part 2: Specification for gloves made from poly(vinyl chloride. Adopted with national modifications from ISO 11193-2:2006 ABNT NBR ISO 11193-1:2015 Single-use medical examination gloves (rubber latex/rubber). Identical to ISO 11193-1:2008 + AMD 1:2012, since revised Brazil 6.3.1 ABNT NBR ISO 11193-2:2013 Single-use medical examination gloves (poly[vinyl chloride]). Identical to ISO 11193-2:2006 Canada n/a 7.3.1 NTC-ISO 11193-1:2020 Single-use medical examination gloves—Part 1: Specification for gloves made from rubber latex or rubber solution). Identical to ISO 11193-1: 2008 (since revised)  Colombia 8.3.1 NTC-ISO 11193-2:2020 Single-use medical examination gloves. Part 2: Specification for gloves made from poly(vinyl chloride). Identical to ISO 11193- 2:2006 37 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets IS 15354-1:2018 Single-use medical examination gloves—Part 1: Specification for gloves made from rubber latex or rubber solution. Identical to ISO 11193-1: 2008 (since revised) IS 15354-2:2018 Single-use medical examination gloves—Part 2: Specification for gloves made from poly(vinyl chloride). Identical to ISO 11193-2: 2006 India 9.3.1 IS 6994-7:2021 Protective gloves­ —general requirements and test methods. Identical to ISO 21420:2020  IS 6994-5: 2021 Protective gloves against dangerous chemicals and micro- organisms­ —r ­ equirements for micro-organisms risks. Identical to ISO 374-5:2016 JS 809 series (Medical gloves for single use)  JS 809-1:2005 Requirements and testing for freedom from holes. Identical to EN 455-1:2000 (since revised) JS 809-2: 2014 Requirements and testing for physical properties. Identical to EN Jordan 455-2:2009 (since revised) 10.3.1 JS 809-3: 2014 Requirements and testing for biological evaluation. Identical to EN 455-3: 2006 (since revised) JS 809-4: 2014 Requirements and testing for shelf-life determination. Identical to EN 455-4: 2009 KS ISO 11193-1:2020 Single-use medical examination gloves—Part 1: Specification for gloves made from rubber latex or rubber solution). Identical to ISO 11193-1:2008 with AMD1: 2012 (since revised)  Kenya 11.3.1 KS ISO 11193-2:2006 Single-use medical examination gloves. Part 2: Specification for gloves made from poly(vinyl chloride). Identical to ISO 11193- 2:2006 (current) MS 2299-1:2010 Medical gloves for single use—Part 1: Requirements and testing for freedom from holes. Identical to EN 455-1:2000, (since revised)  Malaysia 12.3.1 MS 2299-3:2010 Medical gloves for single use—Part 3: Requirements and testing for biological evaluation. Identical to EN 455-3:2006 (since revised) SANS 11193-1:2010, Single-use medical examination gloves­­ —Part 1: Specification South Africa for gloves made from rubber latex or rubber solution). Identical to ISO 11193-1: 13.3.1 2008 (since revised) BS EN 455 series (Medical gloves for single use)  BS EN 455-1: 2020 Requirements and testing for freedom from holes BS EN 455-2: 2015 Requirements and testing for physical properties BS EN 455-3: 2015 Requirements and testing for biological evaluation  UK BS EN 455-4: 2009 Requirements and testing for shelf-life determination 14.3.1 BS EN ISO 21420:2020 Protective gloves—general requirements and test methods  BS EN ISO 374-5: 2016 Protective gloves against dangerous chemicals and micro-organisms—requirements for micro-organisms risks TCVN 6343-1:2007 Single-use medical examination gloves—Part 1: Specification for gloves made from rubber latex or rubber solution. Identical to ISO 11193-1: 2002 with AMD 1: 2007 (since revised)  TCVN 6343-2:2007 Single-use medical examination gloves. Part 2: Specification Vietnam 15.3.1 for gloves made from poly(vinyl chloride) Identical to ISO 11193-2:2006 (current) TCVN 12326-5:2018 Protective gloves against dangerous chemicals and micro- organisms—Part 5: Terminology and performance requirements for micro- organisms risks. Identical to ISO 374-5:2016 (current) 38 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 2.3.2 Surgical gloves The standard EN 455-2 defines a surgical glove as a “sterile, anatomically shaped medical glove with the thumb positioned toward the palmar surface of the index finger rather than lying flat and intended for use in invasive surgery.” Many surgical gloves also make claims as PPE, protecting the wearer from infective agents, aggressive medical chemicals, and pharmaceuticals for chemotherapy. These will comply with EN 420 (replaced by EN ISO 21420), EN ISO 374-1, and EN 374-5, as well as EN 388 where claims of mechanical protection are made. The standard ISO 10282:201418 describes two main types of surgical gloves: those made primarily from natural rubber latex and those made primarily from nitrile rubber latex, isoprene rubber latex, polychloroprene rubber latex, styrene-butadiene rubber solution, styrene-butadiene rubber emulsion, or thermoplastic elastomer solution. They normally have long cuffs that ideally reach to the mid-forearm and a minimum thickness of 0.10 mm. They come in a wide range of sizes and are of a hand-specific design. Typical characteristics for surgical gloves: • Provide a higher level of integrity (freedom medical examination gloves from holes) compared to examination gloves • Free of powder residue • Anatomically designed (more precise range of • Biocompatible sizing than medical examination gloves) • Non-irritating for the skin • Tensile properties generally higher than for Regardless of the material, it is generally accepted that surgical gloves are provided in a sterile condition for use in surgical procedures, whereas examination gloves are used in non-surgical procedures and are not usually sterile. They are all medical gloves, but the level of dexterity needed for examination gloves means that their design is often less anatomically shaped and can include flat stamped gloves. Table 2.8 provides an overview of the main national product standards for surgical gloves in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. 18 ISO 10282:2014. “Single-use sterile rubber surgical gloves—specification.” 39 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 2.8: Overview of the standards for surgical gloves in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) ISO 10282:2014 Single-use sterile rubber surgical gloves—specification ISO standards ISO 21420:2020 Protective gloves—general requirements and test methods (for 4.3.2.3 ISO 374-5:2016 Protective gloves against dangerous chemicals and micro- comparison) organisms­ —requirements for micro-organisms risks EN 455 series (Medical gloves for single use)  EN 455-1: 2020 Requirements and testing for freedom from holes  EN 455-2: 2015 Requirements and testing for physical properties EN 455-3: 2015 Requirements and testing for biological evaluation  EU 4.3.2.1 EN 455-4: 2009 Requirements and testing for shelf-life determination EN ISO 21420:2020 Protective gloves—general requirements and test methods EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro- organisms—requirements for micro-organisms risks  United States ASTM D3577 − 19 Standard specification for rubber surgical gloves 4.3.2.2 AS/NZS 4179:2014 Single-use sterile rubber surgical gloves—specification. Adopted Australia 5.3.2 with national modifications from ISO 10282:2014  Brazil ABNT NBR ISO 10282:2014 Single-use sterile rubber surgical gloves 6.3.2 Canada n/a 7.3.2 Colombia n/a 8.3.2 IS 13422:1992 (reaffirmed 2018) Disposable surgical gloves specification. Based on ASTM D3577-88 (since revised) IS 6994-7:2021 Protective gloves—general requirements and test methods. Identical India 9.3.2 to ISO 21420:2020  IS 6994-5: 2021 Protective gloves against dangerous chemicals and micro- organisms—requirements for micro-organisms risks. Identical to ISO 374-5:2016 JS 809 series (Medical gloves for single use)  JS 809-1:2005 Requirements and testing for freedom from holes. Identical to EN 455-1:2000 (since revised) JS 809-2: 2014 Requirements and testing for physical properties. Identical to EN Jordan 455-2:2009 (since revised) 10.3.2 JS 809-3: 2014 Requirements and testing for biological evaluation. Identical to EN 455-3: 2006 (since revised) JS 809-4: 2014 Requirements and testing for shelf-life determination. Identical to EN 455-4: 2009 KS ISO 10282:2014 Single-use sterile rubber surgical gloves. Identical to ISO Kenya 11.3.2 10282:2014 (current) MS 2299-1:2010 Medical gloves for single use—Part 1: Requirements and testing for freedom from holes. Identical to EN 455-1:2000, (since revised)  Malaysia 12.3.2 MS 2299-3:2010 Medical gloves for single use—Part 3: Requirements and testing for biological evaluation. Identical to EN 455-3:2006 (since revised) SANS 68:2003 Single-use sterile rubber surgical gloves. Identical to ISO 10282:2002 South Africa 13.3.2 (since revised) BS EN 455 series (Medical gloves for single use)  BS EN 455-1: 2020 Requirements and testing for freedom from holes BS EN 455-2: 2015 Requirements and testing for physical properties BS EN 455-3: 2015 Requirements and testing for biological evaluation UK 14.3.2 BS EN 455-4: 2009 Requirements and testing for shelf-life determination BS EN ISO 21420:2020 Protective gloves—general requirements and test methods  BS EN ISO 374-5: 2016 Protective gloves against dangerous chemicals and micro- organisms­ —requirements for micro-organisms risks TCVN 6344:2007 Single-use sterile rubber surgical gloves. Identical to ISO Vietnam 15.3.2 10282:2002 (since revised) 40 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 2.4 Clothing In the case of protective clothing, the ways in which requirements are specified in different parts of the world can vary significantly. Some standards are generic and apply to all kinds of protective clothing, while others are aimed at specific sub-categories. Test methods, such as those for protection against infective agents using synthetic blood, are often common to all categories. For example, ASTM F1670/F1670M19 (resistance to penetration by synthetic blood) applies to “finished items of protective clothing including gloves, arm shields, aprons, gowns, coveralls, hoods, and boots.” Typical characteristics for (most types of) clothing: • Innocuousness (absence of allergenic/ resistance) carcinogenic substances; azo dyes that are • Penetration resistance to infective agents often used to treat textiles) • Requirements for seams, joins and • Designs offer comfort/freedom of movement assemblages (strength and resistance to • Some materials may be breathable penetration by liquids) • Aging resistance (dimensional change after • May also offer chemical resistance cleaning and legibility of marking for reusable (permeation by chemicals, repellence of and products) penetration by liquids) • Mechanical properties (tensile strength, • Not of a highly flammable nature abrasion, puncture, tear and flex-cracking This guide has taken the approach of separating clothing into two main categories, as follows: • Full-body and partial-body (PB) garments, which are typically regulated as PPE and addressed by common (generic) standards: • Full-body garments include protective suits and coveralls • Partial-body garments include aprons and shoe/head covers • Surgical/isolation gowns (which are covered by medical device regulations in most jurisdictions). 19 ASTM F1670/F1670M -17a. “Standard test method for resistance of materials used in protective clothing to penetration by synthetic blood.” 41 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Note: One type of clothing often referred to in the general health care context is “surgical scrubs” that may be worn under protective clothing. According to WHO recommendations these are considered to be regular “on-duty” wear and not PPE. 2.4.1 Full-body and partial-body garments 2.4.1.1 Full-body garments (including protective suits/coveralls) There are no internationally recognized COVID-19-specific definitions of these garments, but the following can be considered to apply: • (From standard ISO 1660220) “Chemical protective suit—clothing worn to protect against chemicals that covers the whole, or greater part of the body Note 1: A chemical protective suit can consist of garments combined together to provide protection to the body. A suit can also have various types of additional protection such as hood or helmet, boots, and gloves joined with it. Note 2: These garments are full-body protective clothing, that is, covering trunk, arms, and legs, such as one-piece coveralls or two-piece suits, with or without hood or visors, with or without foot protection.” Chemical protective clothing can be effective against infective agents when additional testing is performed, for example, to ISO 16603, ISO 16604, ISO 22610, ISO/DIS 22611 or ISO 22612. Most coveralls have a zipper in the front. • (From Indian Standard IS 17423:202121) “Bio-protective coverall is a type of personal protective equipment intended to be worn by health care personnel for the purpose of isolating all parts of the body from a potential hazard.” Table 2.9 provides an overview of the main national product standards for full-body garments in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. 20 ISO 16602: 2007 (amended in 2012). “Protective clothing for protection against chemicals­­­ —classification, labeling and performance requirements.” 21 Bureau of Indian Standards. IS 17423:2021. “Medical textiles—bio-protective coveralls—specification.” 42 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 2.9: Overview of the standards for full-body garments in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) ISO 13688:2013 + AMD 1:2021 Protective clothing—general requirements ISO standards ISO 16602:2007+AMD 1:2012 Protective clothing for protection against 4.4.1.3 (for comparison) chemicals—classification, labeling and performance requirements EN ISO 13688:2013 + A1:2021 Protective clothing—general requirements  EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents EN 13034:2005+A1:2009 Protective clothing against liquid chemicals­ — performance requirements for chemical protective clothing offering limited EU 4.4.1.1 protective performance against liquid chemicals (Type 6 and Type PB [6] equipment) EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals­ — performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) NFPA 1999 (2018) Standard on protective clothing and ensembles for emergency United States 4.4.1.2 medical operations AS/NZS 4501.2:2006 Occupational protective clothing—Part 2: General Australia requirements. Identical adoption of EN 340:2004 (since replaced by EN ISO 13688 5.4.1 + A1:2021) ABNT NBR 16693:2018 Textile products for health­ —non-surgical gowns and Brazil private clothing used for non-surgical procedure professionals and patients­ — 6.4.1 requirements and test methods Canada n/a 7.4.1 NTC 6434:2020 Protective clothing. Requirements and test methods for clothing protection against biological agents. Identical to EN 14126:2003 (current) NTC-EN 14605:2020 Protective clothing against liquid chemicals. Requirements performance for clothing with liquid-tight seams (Type 3) or with spray-tight joints (Type Colombia 4), including garments that offer protection only to certain parts of the body (Types PB [3] 8.4.1 and PB [4]). Identical to EN 14605:2005+A1:2009 (current) NTC-EN 13034:2020 Protective clothing against liquid chemicals. Requirements performance for chemical protective clothing that offers protection limited against liquid chemicals (Type 6 and PB [6] equipment). Identical to EN 13034:2005+A1:2009 (current) India IS 17423:2021 Medical textiles—bio-protective coveralls—specification 9.4.1 JS 1899:2009 Protective clothing for protection against chemicals—classification, Jordan 10.4.1 labeling, and performance requirements. Identical to ISO 16602:2007, since amended KS ISO 13688:2013 Protective clothing—general requirements. Identical to ISO 13688:2013, since amended. Kenya 11.4.1 KS 2409-07:2018 Health care wastes management commodities Part 7: Overall clothings—specification MS ISO 13688:2020 Protective clothing—general requirements. Identical to ISO Malaysia 12.4.1 13688:2013, since amended  S. Africa n/a 13.4.1 BS EN ISO 13688:2013+A1:2021 Protective clothing—general requirements  BS EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents BS EN 13034:2005+A1:2009 Protective clothing against liquid chemicals—performance UK requirements for chemical protective clothing offering limited protective performance 14.4.1 against liquid chemicals (Types 6 and PB [6] equipment)  BS EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) 43 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets TCVN 6689:2021 Protective clothing - General requirements. Identical to ISO Vietnam 15.4.1 13688:2013 + AMD1:2021 2.4.1.2 Partial-body garments Aprons There is no international product-specific standard for aprons, so these are normally considered under more generic PPE performance standards and regulations. In particular, aprons can claim to offer partial-body protection (denoted as PB in ISO 16602) according to that standard, or EN 14126, which is more specific for health care environments. Alternatively, apron manufacturers can demonstrate compliance of their product directly with the essential health and safety requirements of the PPE Regulation in Europe (sections 1 and 2 of Annex II of the regulation). A common definition of an apron is “an outer garment covering the front of the body for protection of clothing during surgery or certain nursing procedures.”22 Aprons can be further divided into three sub-categories:23 I. Heavy-duty aprons, typically made of 100  percent polyester with a PVC coating, 100  percent PVC, 100  percent rubber, 100  percent reusable and biodegradable material, or other fluid-resistant coated material. They are waterproof, with a sewn strap for neck and back fastening or made from single material cut film. They are typically reusable (provided appropriate arrangements for decontamination are in place) or biodegradable. II. Light-duty single-use straight sleeveless and seamless protective aprons that are stain resistant and liquid-proof (resistant to water and disinfectant [70 percent ethanol and 0.05 percent chlorine solution]). III. Thumb-looped aprons, intended to be used in situations where exposure to splashes, droplets and fluids containing infectious agents or chemicals is likely. A thumb-looped apron is made from a plastic, such as low-density polyethylene, constructed in a similar manner to a gown and has thumb loops to ensure that the cuff remains in place during use and when, for example, gloves are donned. Thumb-looped aprons are usually non-sterile and are also referred to as thumb-looped gowns. Light-duty aprons and thumb-looped aprons are unlikely to pass the mechanical requirements of ISO 16602 or other PPE clothing standards and so may be the subject of a local technical specification in order to demonstrate compliance. The EU has made clear that these cannot be used as PPE, but the UK’s National Health Service, for example, has developed its own technical requirements to satisfy national regulations. Typical heavy-weight apron Typical light-weight apron Typical thumb-looped apron Table 2.10 provides an overview of the main national product standards for aprons in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. 22 As defined in The Free Dictionary, https://medical-dictionary.thefreedictionary.com/apron. 23 World Health Organization. November 2020. Technical Specifications of Personal Protective Equipment for COVID-19. Interim Guidance, 13. 44 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 2.10: Overview of the standards for aprons in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) ISO standards ISO 13688:2013 + AMD 1:2021 Protective clothing—general requirements (for ISO 16602:2007+AMD 1:2012 Protective clothing for protection against 4.4.1.3 comparison) chemicals—classification, labeling and performance requirements EN ISO 13688:2013+A1:2021 Protective clothing—general requirements  EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents EN 13034:2005+A1:2009 Protective clothing against liquid chemicals— performance requirements for chemical protective clothing offering limited EU protective performance against liquid chemicals (Type 6 and Type PB [6] 4.4.1.1 equipment)  EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals­ — performance requirements for clothing with liquid-tight (Type 3) or spray- tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) NFPA 1999 (2018) Standard on protective clothing and ensembles for United States 4.4.1.2 emergency medical operations AS/NZS 4501.2:2006 Occupational protective clothing—Part 2: General Australia requirements. Identical adoption of EN 340:2004 (since replaced by EN ISO 5.4.1 13688 + A1:2021) ABNT NBR 16693:2018 Textile products for health—non-surgical gowns Brazil and private clothing used for non-surgical procedure professionals and 6.4.1 patients—requirements and test methods Canada n/a 7.4.1 NTC 6434:2020 Protective clothing. Requirements and test methods for clothing protection against biological agents. Identical to EN 14126:2003 (current) NTC-EN 14605:2020 Protective clothing against liquid chemicals. Requirements performance for clothing with liquid-tight seams (Type 3) or with spray-tight joints (Type 4), including garments that offer protection Colombia 8.4.1 only to certain parts of the body (Types PB [3] and PB [4]). Identical to EN 14605:2005+A1:2009 (current) NTC-EN 13034:2020 Protective clothing against liquid chemicals. Requirements performance for chemical protective clothing that offers protection limited against liquid chemicals (Types 6 and PB [6] equipment). Identical to EN 13034:2005+A1:2009 (current) India n/a 9.4.1 JS 1899:2009 Protective clothing for protection against chemicals— Jordan classification, labeling, and performance requirements. Identical to ISO 10.4.1 16602:2007, since amended KS 2409-3:2018 Health care wastes management commodities. Kenya 11.4.1 Specification- Part 3: Plastic apron MS ISO 13688:2020 Protective clothing—general requirements. Identical to Malaysia 12.4.1 ISO 13688:2013, since amended  South Africa n/a 13.4.1 45 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets BS EN ISO 13688:2013+A1:2021 Protective clothing—general requirements  BS EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents BS EN 13034:2005+A1:2009 Protective clothing against liquid chemicals— performance requirements for chemical protective clothing offering limited UK protective performance against liquid chemicals (Type 6 and Type PB [6] 14.4.1 equipment)  BS EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals— performance requirements for clothing with liquid-tight (Type 3) or spray- tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) TCVN 6689:2021 Protective clothing—general requirements. Vietnam 15.4.1 Identical to ISO 13688:2013 + AMD1:2021 Shoe/head covers These two categories fall into a gray area as far as COVID-19-related PPE is concerned. In defining the relevant technical regulations and standards to be considered, it is important to remember that PPE is “intended to protect the wearer from a hazard.” Typical shoe covers Typical head cover Although often used as PPE for filovirus outbreaks (such as Ebola), according to the WHO the likelihood of COVID-19 transmission via footwear is very low. However, it is good practice in sterile environments to use hygienic foot coverings that typically just extend over the base of the user’s normal footwear. These do not provide any protection to the wearer and are therefore not considered to be PPE, although they may be considered as medical devices if the purpose is to minimize the transmission of disease by the wearer. On the other hand, a foot covering that extends up over the ankle and claims to protect that part of the wearer’s body would be considered as PPE. A similar rationale applies to head coverings, which are only considered PPE if they claim to be capable of protecting the wearer. Otherwise, they would be considered as medical devices. Therefore, it can be stated for both head and shoe coverings that they can claim to offer partial-body protection. Table 2.11 provides an overview of the main national product standards for shoe/head covers in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. 46 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 2.11: Overview of the standards for shoe/head covers in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) ISO standards ISO 13688:2013 + AMD 1:2021 Protective clothing—general requirements (for ISO 16602:2007+AMD 1:2012 Protective clothing for protection against 4.4.1.3 comparison) chemicals—classification, labeling and performance requirements EN ISO 13688:2013+A1:2021 Protective clothing—general requirements  EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents EN 13034:2005+A1:2009 Protective clothing against liquid chemicals— performance requirements for chemical protective clothing offering limited EU protective performance against liquid chemicals (Type 6 and Type PB [6] 4.4.1.1 equipment)  EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals— performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) United States n/a 4.4.1.2 AS/NZS 4501.2:2006 Occupational protective clothing—Part 2: General Australia requirements. Identical adoption of EN 340:2004 (since replaced by EN ISO 13688 5.4.1 + A1:2021) ABNT NBR 16693:2018 Textile products for health—non-surgical gowns and Brazil private clothing used for non-surgical procedure professionals and patients­— 6.4.1 requirements and test methods Canada n/a 7.4.1 NTC 6457:2020 Disposable hats/caps Colombia 8.4.1 NTC 6451:2020 Disposable foot covers India n/a 9.4.1 Jordan n/a 10.4.1 Kenya n/a 11.4.1 MS ISO 13688:2020 Protective clothing—general requirements. Identical to ISO Malaysia 12.4.1 13688:2013, since amended  South Africa n/a 13.4.1 BS EN ISO 13688:2013+A1:2021 Protective clothing—general requirements  BS EN 14126:2003 Protective clothing­ —performance requirements and tests methods for protective clothing against infective agents BS EN 13034:2005+A1:2009 Protective clothing against liquid chemicals— performance requirements for chemical protective clothing offering limited UK protective performance against liquid chemicals (Type 6 and Type PB [6] 14.4.1 equipment) BS EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals— performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) TCVN 6689:2021 Protective clothing—general requirements. Vietnam 15.4.1 Identical to ISO 13688:2013 + AMD1:2021 47 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 2.4.2 Gowns These can be disposable (for single use) and made from non-woven material, or reusable and made from woven material. Laminate films or additional layers are used for some products to provide higher levels of liquid penetration resistance. Gowns typically come in sizes S, M, L, and XL with a length down to the mid- calf. In the United States, gowns are subdivided into two specific categories, as follows: • (From ASTM F3352-19) “Isolation gown: item of protective clothing/apparel used to protect health care personnel, visitors, and patients from the transfer of micro-organisms and body fluids in patient isolation situations” • (From ASTM F2407-20) “Surgical gown: protective clothing that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of micro-organisms, body fluids, and particulate matter.” Based on their intended use, the main difference between the two is that a surgical gown is sterile (with a back area that is not necessarily protective) while an isolation gown (used in a medical setting other than surgery) is not necessarily sterile but is expected to provide 360° protection to the health care worker. Because they have a medical purpose, isolation gowns are also considered to be medical devices.24 In both cases, critical zones may be required to be more fluid resistant than non-critical zones and reusable gowns should meet the minimum performance requirements after the maximum suggested laundering cycles. Gowns are most often constructed from polypropylene or polyester fibers, using a non-woven technique such as SMS (spunbond, meltblown, spunbond). They can be separated into different categories based on their level of protection. This is usually based on liquid barrier performance involving spray impact penetration testing and hydrostatic pressure tests. The spray impact test determines if the product is protective or not. The hydrostatic pressure test result determines the level of protection, typically ranging from 1 to 4 (US classification) as follows: • Level 1: Minimal risk, to be used during basic care, standard isolation, cover gown for visitors, or in a standard medical unit • Level 2: Low risk, to be used during blood draw, suturing, in the intensive care unit, or a pathology lab • Level 3: Moderate risk, to be used during arterial blood draw, inserting an intravenous line, in the emergency room, or for trauma cases • Level 4: High risk, to be used during long, fluid-intense procedures, surgery when pathogen resistance is needed or (non-airborne) infectious diseases are suspected. This level includes surgical gowns and protective apparel. Example of an isolation gown Example of a surgical gown 24 Other types of gowns may include patient gowns (intended to be worn by patients in a clinical setting) and professional examination gowns, to be used by health care staff, sometimes over scrub suits, while examining patients. 48 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 2.12 provides an overview of the main national product standards for gowns in the markets covered by this guide and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 2.12: Overview of the standards for gowns in each of the selected markets Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More Market Main product standards details (link) ISO n/a (Future product standard under development ISO 20384 Medical gowns, surgical standards drapes and protective apparel—performance requirements, performance levels and - (for test methods) comparison) EN 13795-1:2019 Surgical clothing and drapes—requirements and test methods—Part EU 4.4.2.1 1: Surgical drapes and gowns ASTM F2407-20 Standard specification for surgical gowns intended for use in health care facilities  ASTM F3352-19 Standard specification for isolation gowns intended for use in health United States 4.4.2.2 care facilities ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities AS 3789.2–1991+AMDT 1 (1992) Textiles for health care facilities and institutions— Australia 5.4.2 theatre linen and pre-packs ABNT NBR 16064:2021 Textiles for health—surgical drapes and gowns­ — requirements Brazil 6.4.2 and test methods. Based on EN 13795-1:2019 CSA Z314-2018 Canadian medical device reprocessing. Partially based on ANSI/AAMI Canada 7.4.2 PB 72 NTC 5623:2020 Surgical drapes and sheets. Requirements and test methods. Part 1: Colombia 8.4.2 Surgical drapes and gowns. Identical to EN 13795-1:2019 India IS 17334:2019 Medical textiles—surgical gowns and surgical drapes— specification 9.4.2 JS 983-1:2007 Surgical drapes, gowns, and clean air suits, used as medical devices for patients, clinical staff, and equipment. Part 1: General requirements for manufacturers, processors, and products. Equivalent to EN 13795-1:2002, since revised JS 983-2:2007 Surgical drapes, gowns, and clean air suits, used as medical devices for patients, clinical staff, and equipment. Part 2: Test methods. Equivalent to EN 13795- Jordan 10.4.2 2: 2002, since revised JS 983-3:2008 Surgical drapes, gowns, and clean air suits, used as medical devices for patients, clinical staff, and equipment. Part 3: Performance requirements and performance levels. Equivalent to EN 13795-3:2006, since merged with EN 13795-1 and EN 13795-2 Kenya n/a 11.4.2 Malaysia n/a 12.4.2 SANS 53795:2015 Surgical drapes, gowns, and clean air suits, used as medical devices for patients, clinical staff, and equipment—general requirements for manufacturers, South Africa 13.4.2 processors, and products; test methods, performance requirements, and performance levels. Identical to EN 13795, since replaced by EN 13795-1 and EN 13795-2 BS EN 13795-1:2019 Surgical clothing and drapes—requirements and test methods— UK 14.4.2 Part 1: Surgical drapes and gowns Vietnam n/a 15.4.2 49 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 3 OVERVIEW OF MARKET REQUIREMENTS 3.1 European Union 3.1.1 Regulatory landscape for COVID-19-related PPE In the EU, all PPE is subject to regulation (EU) 2016/425 on personal protective equipment (the PPE Regulation) which covers the design, manufacture, and marketing of PPE. It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides a declaration of compliance of the product with the applicable EU legislation. Annex I of the PPE Regulation classifies protective equipment according to its level of risk, as follows: Category I is exclusively for minimal risks such as: • Superficial mechanical injury • Contact with cleaning materials of weak action or prolonged contact with water • Contact with hot surfaces not exceeding 50°C • Damage to the eyes due to exposure to sunlight (other than during observation of the sun) • Atmospheric conditions that are not of an extreme nature. Category II relates to risks other than those listed in categories I and III. Category III exclusively includes risks that may cause very serious consequences such as death or irreversible damage to health including, among others: • Substances and mixtures which are hazardous to health • Atmospheres with oxygen deficiency • Harmful biological agents. Most of the COVID-19-related PPE covered by this guide is classified as Categories II or III. Users are also referred to the PPE Regulation Guidelines (1st edition—April 2018) issued by the European Commission,25 which aim to facilitate a common understanding and implementation of the PPE Regulation. With regards to the PPE Regulation, manufacturers are required to: • Ensure that the PPE has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II of the regulation • Draw up the technical documentation referred to in Annex III (technical file) and carry out the applicable conformity assessment procedure 25 https://ec.europa.eu/docsroom/documents/29201/attachments/1/translations/en/renditions/native. 50 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets • Draw up the EU declaration of conformity and affix the CE marking • Keep the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market • Ensure that procedures are in place for series production to remain in conformity with the regulation • Keep a register of complaints, of non-conforming PPE and PPE recalls, and keep distributors informed of any such monitoring • Ensure that the PPE which they place on the market bears marking allowing its identification or, where the size or nature of the PPE does not allow it, on the packaging or in a document accompanying the PPE • Indicate on the PPE their name, registered trade name or registered trademark and the postal address at which they can be contacted, or where that is not possible, on its packaging or in a document accompanying the PPE • Ensure that the PPE is accompanied by instructions and information in a language which can be easily understood by consumers and other end users, as determined by the member state concerned • Where the PPE presents a risk, immediately inform the competent national authorities of the relevant member state(s), giving details of the non-conformity and of any corrective measures taken • Further to a reasoned request from a competent national authority, provide all the information and documentation necessary to demonstrate the conformity of the PPE in paper or electronic form, in a language which can easily be understood by that authority. Many items of COVID-19-related PPE can also be subject to regulations related to medical devices, depending on their specific application. Therefore, it is important to refer back to section 1.4 of this guide for a more detailed conceptual explanation. For medical devices, Regulation (EU) 2017/745 (the Medical Devices Regulation, or MDR) has been applicable since May 26, 2021, following a four-year transition period. The MDR repealed Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable medical devices, and manufacturers must comply with the MDR when placing new medical devices on the market. This is particularly relevant because where the intended use of a product is both as PPE and as a medical device, the full extent of both regulations is applied. 3.1.2 Approach to standardization and key product standards for PPE In the context of PPE, the European Committee for Standardization (CEN) is responsible for the development and publication of regional (EN) standards.26 These are then adopted by each member state’s national standards body as its own national standards and any conflicting national standards are withdrawn. CEN also participates in the development of ISO standards under the so-called Vienna Agreement. Where an EN standard is an adoption of an ISO standard, it receives the designation “EN ISO.” National adoptions— for example, in Portugal­ —are referred to as “NP EN” or “NP EN ISO” standards to emphasize that they are identical in content. Both the PPE Regulation (EU 2016/425) and the MDR (EU 2017/745) are based on the “New Approach Directives” (introduced in 1985) aligned to the EU’s more recent (2010) “New Legislative Framework” policy. This means that manufacturers or their authorized representatives in the EU must demonstrate compliance with the essential health and safety or performance requirements of the applicable regulation either directly or by demonstrating conformity to the associated harmonized EN standards (a “presumption of conformity” to the regulation). Because the regulations are often very generic and performance-based in their requirements (which in some cases can apply to broad families of products), demonstration of conformity 26 The European Committee for Electrotechnical Standardization (CENELEC) also develops regional standards, but these are not normally applicable to PPE or the medical devices under consideration in this guide. 51 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets to the harmonized standards is often the preferred way of demonstrating conformity to the regulation. Table 3.1 provides an overview of the main product standards for PPE in the EU market. Table 3.1: Overview of COVID-19-related PPE standards in the EU market More PPE Main product standards details (link) EN 149:2001+A1:2009 RPD—filtering half-masks to protect against particles- requirements, testing, marking Respirators 4.1.1.1 EN 143:2021 Respiratory protective devices—particle filters—requirements, testing, marking Medical face EN 14683:2019 Medical face masks—requirements and test methods 4.1.2.1 masks Community CWA 17553:2020 Community face coverings—guide to minimum requirements, face 4.1.3.1 methods of testing and use  coverings Face shields EN 166:2001 Personal eye protection—specifications 4.2.1 Protective EN 166:2001 Personal eye protection—specifications 4.2.1 goggles EN 455 series (Medical gloves for single use)  EN 455-1: 2020 Requirements and testing for freedom from holes  EN 455-2: 2015 Requirements and testing for physical properties Medical EN 455-3: 2015 Requirements and testing for biological evaluation  examination 4.3.1.1 EN 455-4: 2009 Requirements and testing for shelf-life determination gloves EN ISO 21420:2020 Protective gloves—general requirements and test methods EN ISO 374-5: 2016 Protective gloves against dangerous chemicals and micro- organisms—requirements for micro-organisms risks  EN 455 series (Medical gloves for single use)  EN 455-1: 2020 Requirements and testing for freedom from holes  EN 455-2: 2015 Requirements and testing for physical properties Surgical EN 455-3: 2015 Requirements and testing for biological evaluation  4.3.2.1 gloves EN 455-4: 2009 Requirements and testing for shelf-life determination EN ISO 21420:2020 Protective gloves—general requirements and test methods EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro- organisms—requirements for micro-organisms risks  EN ISO 13688:2013 + A1:2021 Protective clothing—general requirements  EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents EN 13034:2005+A1:2009 Protective clothing against liquid chemicals— performance Suits and requirements for chemical protective clothing offering limited protective performance 4.4.1.1 coveralls against liquid chemicals (Type 6 and Type PB [6] equipment) EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals— performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) EN ISO 13688:2013+A1:2021 Protective clothing—general requirements  EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents EN 13034:2005+A1:2009 Protective clothing against liquid chemicals— performance requirements for chemical protective clothing offering limited protective performance Aprons 4.4.1.1 against liquid chemicals (Type 6 and Type PB [6] equipment)  EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals— performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) 52 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets EN ISO 13688:2013+A1:2021 Protective clothing—general requirements  EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents EN 13034:2005+A1:2009 Protective clothing against liquid chemicals— Performance Shoe and requirements for chemical protective clothing offering limited protective performance 4.4.1.1 head covers against liquid chemicals (Type 6 and Type PB [6] equipment)  EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals— performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) EN 13795-1:2019 Surgical clothing and drapes—requirements and test methods—Part Gowns 4.4.2.1 1: Surgical drapes and gowns 3.1.3 Approach to conformity assessment In Europe, all PPE and medical devices must comply with the associated regulation and bear the CE marking. The CE marking on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant EU legislation and the product may be made available anywhere in the European Economic Area. It is a criminal offence to affix a CE marking to a product that is not compliant or to offer it for sale. Within Europe, accreditation of conformity assessment bodies is coordinated by the European Accreditation Cooperation (EA). EA was formally appointed by the European Commission via Regulation (EC) No 765/2008 to develop and maintain a multilateral arrangement of mutual recognition of national accreditation bodies (the EA multilateral arrangement) based on a harmonized accreditation infrastructure. There can be only one recognized accreditation body per EU member state. Examples include Accredia (Italy), DAkkS (Germany) and SNAS (Slovakia). Depending on the risk classification, certain categories of PPE and medical devices are subject to conformity assessment by a notified body. Notification is an act whereby an EU member state informs the European Commission and the other member states that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to an EU directive or regulation. Notification of conformity assessment bodies and their withdrawal are the responsibility of the notifying member state. Full details of notified bodies can be found in the NANDO (New Approach Notified and Designated Organizations) information system.27 The “preferred” method for appointing notified bodies is through accreditation. But, if another method is used, the competent authority of the member state concerned has to be able to demonstrate that the method is technically equivalent to accreditation. Medical devices are one area where alternative routes are used in a number of EU countries. For PPE, there are a number of ways of demonstrating conformity depending on the product category and associated risks. This is shown schematically in Table 3.2 and in Figure 3.1. 27 https://ec.europa.eu/growth/tools-databases/nando/index.cfm. 53 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 3.2: Conformity assessment per the EU PPE Regulation for different product categories PPE category Activity PPE Regulation (EU) 2016/425 Module A (Annex IV) I (Simple PPE) Placing product onto the market Manufacturers self- declaration of conformity II (Intermediate) and III Module B (Annex V) Initial product approval (Complex PPE) EU-type examination II (Intermediate PPE) Internal production control Module C (Annex VI) Ongoing surveillance through Module C2 (Annex VII) testing OR III (Complex PPE only) Ongoing surveillance through Module D factory auditing (Annex VIII) Figure 3.1: EU criteria for conformity assessment of PPE Category I Category II Category III PPE PPE PPE Technical documentation EU type-examination (Mod. B, Annex V) Ctt. based on Ctt. based on internal production Ctt. based on quality Internal production internal production control plus superv. assurance of the control (Mod. A, control (Mod. C, product checks at production system Annex IV) Annex VI) random intervals (Mod. D, Annex VIII) (Mod. C2, Annex VII) EU declaration of conformity nnnn Note: “Ctt” = “Conformity to type” 54 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Note that for PPE classified as medical devices the risk categories defined in Annex VIII of the MDR also have to be respected. Medical devices included in the present guide are all Class I (low risk) and all conformity assessment activities are carried out by the manufacturer. The exception is sterile Class I products which require the intervention of a notified body, but only for assessing the manufacturer’s ability to secure and maintain sterile conditions. However, all Class I devices have to be registered with an EU member state’s competent authority, and if the device is imported into the EU, an authorized representative of the manufacturer must be appointed within the EU. 3.2 United States 3.2.1 Regulatory landscape for COVID-19-related PPE The Code of Federal Regulations (CFR) is the codification of the general and permanent regulations published in the Federal Register by the executive departments and agencies of the federal government of the United States. The overall regulatory landscape is quite complex, often with a number of different agencies involved for specific topics and some overlap in jurisdictions. The three main federal agencies involved in the regulation of PPE are the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH)­ —part of the Centers for Disease Control and Prevention (CDC) within the US Department of Health and Human Services—and the Food and Drug Administration (FDA). According to the FDA, “PPE refers to protective clothing, helmets, gloves, face shields, goggles, face masks and/or respirators, or other equipment designed to protect the wearer from injury or the spread of infection or illness.”28 The CFR is divided into 50 titles representing broad areas subject to federal regulation. The US regulations in Title 29 Part 1910 all pertain to OSHA, which directs employers to comply with specific safety standards. For example, 29 CFR Part 1910.132 provides general requirements for employers to provide appropriate PPE to their employees based on a hazard assessment. While citing some basic PPE standards, these regulations do not generally address PPE in the context of infective agents. The only specifically relevant OSHA regulations are 29 CFR Part 1910.134—which defines the elements of a workplace respiratory protection program—and a separate standard for bloodborne pathogens directed to the health care sector, found in 29 CFR Part 1910.1030. Both regulations have relatively simple PPE requirements. These OSHA regulations on respirators are important because they require the selection of specific respirator types based on airborne hazards and, more importantly, require that individual wearers undergo fit testing to show the adequacy of the specific respirator. 3.2.2 Approach to standardization and key product standards for PPE The US approach to standardization and key product standards for PPE can be confusing to those who are not familiar with its concepts and structure. The United States Standards Strategy,29 published in 2020, serves as a statement of purpose and ideals resulting from a re-examination of the principles and strategy that guide how the United States develops standards and participates in the international standards-setting process. This takes into consideration the fact that the United States is a highly diversified society with a market-driven economy and its standards system reflects this diversity, encompassing multiple and varied standards sources. While the American National Standards Institute (ANSI) is the only national standards body, it does not itself develop standards, but instead oversees the development process by accrediting the procedures of a number of standards development organizations within the private-sector voluntary standardization system. In the context of COVID-19-related PPE, the predominant source of standards is ASTM International. However, other standards development organizations also publish standards that are relevant for specific products. These include the: • American Association of Textile Chemists and Colorists (AATCC) • Association for the Advancement of Medical Instrumentation (AAMI) 28 https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/personal-protective-equipment-infection-control. 29 https://www.ansi.org/resource-center/publications-subscriptions/usss. 55 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets • International Safety Equipment Association (ISEA) • National Fire Protection Association (NFPA) • US Pharmacopeia (USP) In some cases, prescriptive performance requirements for PPE are specified directly in the applicable government regulations, without further reference to voluntary standards. One example is 42 CFR Part 84 Subpart K for air-purifying particulate respirators, which includes N95 respirators. Although the US system aims to produce standards that are consistent with the principles of the WTO/TBT Agreement, most standards related to PPE in the United States are national standalone ones, rather than being adoptions of “traditional” international standards such as those developed by ISO. However, it can be argued that many standards developed by ASTM and others follow the good standardization practice recommended by the WTO TBT Committee decision on international standards and a number of ASTM standards have indeed been adopted in other economies or formed the basis for ISO standards. Table 3.3 provides an overview of the main product standards for PPE in the US market. Table 3.3: Overview of COVID-19-related PPE standards in the US market More PPE Main product standards details (link) Respirators 42 CFR 84.170 Air-purifying particulate respirators 4.1.1.2 Medical face ASTM F2100-21 Standard specification for performance of materials used in medical 4.1.2.2 masks face masks Community ASTM F3502-21 Standard specification for barrier face coverings face 4.1.3.2 AATCC M14 Guidance and considerations for general-purpose textile face coverings coverings ANSI/ISEA Z87.1:2020 American national standard for occupational and educational personal eye and face protection devices Face shields ANSI/ISEA Z87.62-2021 American national standard for occupational and educational 4.2.2 personal eye and face protection devices for preventing exposures caused by sprays or spurts of blood or body fluids ANSI/ISEA Z87.1-2020 Occupational and educational personal eye and face protection Protective devices goggles/ ANSI/ISEA Z87.62-2021 American national standard for occupational and educational 4.2.2 glasses personal eye and face protection devices for preventing exposures caused by sprays or spurts of blood or body fluids ASTM D5250-19 Standard specification for poly(vinyl chloride) gloves for medical application  ASTM D6319-19 Standard specification for nitrile examination gloves for medical Medical application examination ASTM D3578-19 Standard specification for rubber examination gloves 4.3.1.2 gloves ASTM D6977-19 Standard specification for polychloroprene examination gloves NFPA 1999 (2018) Standard on protective clothing and ensembles for emergency medical operations ANSI/ISEA 105-2016 American national standard for hand protection classification Surgical ASTM D3577-19 Standard specification for rubber surgical gloves 4.3.2.2 gloves Suits and NFPA 1999 (2018) Standard on protective clothing and ensembles for emergency 4.4.1.2 coveralls medical operations NFPA 1999 (2018) Standard on protective clothing and ensembles for emergency Aprons 4.4.1.2 medical operations Shoe and n/a 4.4.1.2 head covers ASTM F2407-20 Standard specification for surgical gowns intended for use in healthcare facilities  ASTM F3352-19 Standard specification for isolation gowns intended for use in Gowns healthcare facilities 4.4.2.2 ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities 56 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.2.3 Approach to conformity assessment The following is a summary of the conformity assessment and approval processes in the United States for the PPE and medical devices referred to in this guide.30 Specifically for PPE, the recently published ASTM F3050-21 (Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment) applies. Briefly: • All respirators are subject to approval by the NIOSH according to specific national regulations • PPE used in healthcare or for medical purposes is subject to FDA oversight • Moderate-risk PPE (medical face masks, “Level 3 and 4” gowns and gloves) are subject to a clearance process involving comparison with already marketed products • Low-risk PPE (face shields, eyewear, “Level 1 and 2” gowns) have to meet FDA “general controls” that require registration and certain product practices • The NFPA 1999 governs PPE for emergency responders • Requires independent third-party certification • Other standards generally involve minimal conformity assessment requirements. A summary of the criteria for the various categories of PPE covered by this guide is shown in Figure 3.2 and a typical approval process (for respirators) is shown in Figure 3.3. Figure 3.2: Summary of US regulatory oversight for various categories of PPE Respirators Face masks Face shields / Gloves Gowns Other • NIOSH- • Surgical masks eyewear • Must be • High end apparel approved FDA cleared cleared by FDA gowns FDA • Limited FDA • Limited FDA • Small fraction • Addressed • Multiple cleared oversight oversight under FDA by industry industry • Limited FDA • Limited utility • Limited oversight standard standards oversight for of industry industry other gowns standard standards • Some industry standards Source: International Personnel Protection, Inc. 30 Jeffrey O. Stull. International Personnel Protection, Inc., Austin, Texas. 57 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Figure 3.3: Overview of the NIOSH approval process for respirators 1. Receive samples Receiving/Records Room 2. Receive application/documents 3. Receive application fee 1. Review application reason/content 2. Verify new or revised Configuration Initial Engineering Review 3. Issue fee estimate 4. Assign appropriate tests 1. Conduct assigned testing Testing and Quality 2. Assess quality management system Assurance 3. Review inspection and sample procedures 4. Perform final review of documentation 1. Review test data 2. Update NIOSH parts database Final Engineering Review 3. Review and finalize labeling 4. Finalize approval /denial package Source: International Personnel Protection, Inc. For those devices that come under FDA oversight, Figure 3.4 provides a simplified view of the conformity assessment and approval procedures that are required. Figure 3.4: Schematic of the process for FDA approval • Class I devices CLASS I CLASS II CLASS III - Manufacturer meets low risk moderate/controlled risk moderate/controlled risk general controls Exceeds limits of exemption < 4000 patients per year in U.S. • Manufacturer and device registration; good manufacturer 510(k) de novo HDE PMA practice; exempt no substantially 510(k) probable benefit resonable assurance traceability equivalent to outweights risk of safety and efficacy precicate? no predicate • Class II devices yes General controls - Applied to medical Special controls masks, certain gowns Clinical data - Require 510(k) submission according to US FDA regulations CLEARANCE TO MARKET DEVICE APROVAL TO MARKET DEVICE (21 CFR Part 807 Subpart E) An “FDA 510(k)” submission31 is required for all Class II medical device PPE and for some non-exempt Class I medical device PPE, such as examination or surgical gloves, typically including the following steps: • Demonstration of substantial equivalence to product that has already been cleared by the FDA.32 This demonstration involves: • Comparison of the proposed product to the already cleared product in terms of the general design, construction, labeling and—most importantly­—safety and efficacy data that include the results of product testing to key areas of performance 31 For details on the FDA clearance process via a 510(k), see the FDA website at https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances. 32 The word“clearance” is used in lieu of“approval, ” which is reserved for Class III medical devices. 58 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets • Use of, or reference to, FDA guidance documents on the specific product area. However, these documents can sometimes be outdated or not include all of the pertinent information • Use of product standards recognized by the FDA that establish relevant design, performance and labeling requirements • Technical product details • Information completely defining materials, components, design, and product claims • Provision of safety and efficacy data by the manufacturer • Generally, product performance data provided at sampling levels meeting a specified acceptable quality limit (AQL) • For example, the FDA now requires an AQL of 4.0  percent or other specified level when applied to certain medical PPE. In the case of an AQL of 4.0  percent for a certain lot size, the sample size for testing is 32 where 29 of 32 specimens must pass the established criteria. Most recently, the expectation for products is that this performance be separately demonstrated for three non-sequential lots of products. Once again, within the free market competitive landscape in the United States, there are multiple (mainly private sector) accreditation bodies that oversee the conformity assessment processes (laboratory testing, inspection, and product/system certification). Many of these are signatories of the relevant IAF MLA and ILAC MRA. 3.3 Australia 3.3.1 Regulatory landscape for COVID-19-related PPE The Therapeutic Goods Administration (TGA), part of the Department of Health, is the medical and therapeutic regulatory agency of the Australian government. The TGA regulates the quality, supply, and advertising of medicines, pathology devices, medical devices, blood products, and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, or are otherwise covered by the Therapeutic Goods Act (1989), the Therapeutic Goods Regulations 1990, or a ministerial order must be approved by the TGA and registered in the Australian Register of Therapeutic Goods before they can be supplied. Item 1 of Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 specifically states that the following items are considered to be medical devices: “articles that are non- sterile personal protective equipment or safety apparel (including but not limited to aprons, face masks, gloves, goggles, gowns, and visors) intended, by the person under whose name the articles are or are to be supplied, to be used for the prevention of the transmission of disease between persons, including where that intention may be ascertained from the articles being represented as suitable for use in surgery, or clinical, medical, or other health services.” The TGA further clarifies33 that they will “infer the intended use for the PPE from the labeling on the packaging, instructions for use, advertising, and information in the manufacturer’s technical documentation. If any of these materials suggest that the goods are suitable for use in surgery, or clinical, medical, or other health services, the TGA will conclude that the PPE is intended to be used for prevention of the transmission of disease between people. However, even if these materials do not suggest use in surgery, clinical, medical, or other health services, other aspects of the PPE’s presentation could still suggest that it is for the prevention of the transmission of disease.” PPE will generally be regulated as a: 33 https://www.tga.gov.au/behind-news/regulation-personal-protective-equipment-and-covid-19. 59 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets • Class I medical device • Class Is (sterile) medical device • Class IIa medical device Manufacturers can check the classification of their medical device using the online classification tool at https://www.tga.gov.au/sme-assist/what-classification-my-medical-device#100 Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 sets out 15 essential principles with which manufacturers must comply. There are six general essential principles that apply to all devices and nine further essential principles. General essential principles • Use of medical devices not to compromise health and safety • Design and construction of medical devices to conform to safety principles • Medical devices to be suitable for intended purpose • Long-term safety • Medical devices not to be adversely affected by transport or storage • Benefits of medical devices to outweigh any side effects. Design and construction: essential principles These nine essential principles apply to devices on a case-by-case basis: • Chemical, physical and biological properties • Infection and microbial contamination • Construction and environmental properties • Medical devices with a measuring function • Protection against radiation • Medical devices connected to or equipped with an energy source • Information to be provided with medical devices • Clinical evidence • Principles applying to in vitro diagnostic product (IVD) medical devices only 3.3.2 Approach to standardization and key product standards for PPE Although the use of standards to demonstrate compliance with the essential principles is not mandated under the regulations, the TGA recognizes certain standards to assist manufacturers in complying with the conformity assessment procedures and the essential principles.34 Standards Australia is the national standards body and most product standards that apply to PPE in the Australian market are either Australian (AS) or Joint Australian/New Zealand (AS/NZS) Standards. In 34 This is similar to the“presumption of conformity” principle that is widely adopted in the EU. 60 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets general, for PPE, the situation is mixed: there are some standalone national standards and some adoptions (occasionally with modifications) of ISO or regional (for example, CEN) standards.35 There is also acceptance by the TGA of some applicable product standards issued by other national and international standards bodies and the widespread referencing of test method standards issued by ISO, CEN, ASTM, BSI, and others. Table 3.4 provides an overview of the main product standards for PPE in the Australian market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 3.4: Overview of COVID-19-related PPE standards in the Australian market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) Respirators AS/NZS 1712:2012 Respiratory protective devices 5.1.1 Medical face AS 4381:2015 Single-use face masks for use in health care 5.1.2 masks Community face n/a 5.1.3 coverings AS/NZS 1337.1:2010 (+ AMDT 1:2012 + AMDT 2:2018) Personal eye protection—Part 1: Face shields Eye and face protectors for occupational applications. Based on (but not identical to) 5.2 EN 166 AS/NZS 1337.1:2010 (+ AMDT 1:2012 + AMDT 2:2018) Personal eye protection —Part 1: Protective Eye and face protectors for occupational applications. Based on (but not identical to) 5.2 goggles EN 166 AS/NZS 4011.1:2014 Single-use medical examination gloves­ —Part 1: Specification for gloves made from rubber latex or rubber solution. Adopted with national modifications Medical from ISO 11193-1:2008 (since revised) examination 5.3.1 AS/NZS 4011.2:2014 Single-use medical examination gloves—Part 2: Specification for gloves gloves made from poly(vinyl chloride. Adopted with national modifications from ISO 11193-2:2006 Surgical AS/NZS 4179:2014 Single-use sterile rubber surgical gloves—specification. Adopted 5.3.2 gloves with national modifications from ISO 10282:2014  Suits and AS/NZS 4501.2:2006 Occupational protective clothing—Part 2: General requirements. 5.4.1 coveralls Identical adoption of EN 340:2004 (since replaced by EN ISO 13688 + A1:2021) AS/NZS 4501.2:2006 Occupational protective clothing—Part 2: General requirements. Aprons 5.4.1 Identical adoption of EN 340:2004 (since replaced by EN ISO 13688 + A1:2021) Shoe and AS/NZS 4501.2:2006 Occupational protective clothing—Part 2: General requirements. 5.4.1 head covers Identical adoption of EN 340:2004 (since replaced by EN ISO 13688 + A1:2021) AS 3789.2–1991+AMDT 1 (1992) Textiles for health care facilities and institutions— Gowns 5.4.2 theatre linen and pre-packs 35 https://www.standards.org.au/news/information-to-support-covid-19-national-response-and-australian-manufacturers. 61 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.3.3 Approach to conformity assessment All classes of medical devices need conformity assessment evidence before they can be manufactured and placed on the Australian market. Conformity assessment includes the systematic and ongoing examination of evidence and procedures to ensure that a medical device complies with the essential principles (see section 3.3.1). The classification of a medical device determines the conformity assessment procedures a manufacturer can choose to ensure that the device is adequately assessed. Higher risk-class devices must undergo more stringent conformity assessment. Manufacturers of all medical devices manufactured and/or supplied in Australia need to ensure that they have: • Appropriate conformity assessment procedures in place for the device • Appropriate documentation demonstrating compliance of the device with the essential principles. All medical devices to be placed on the Australian market must have a sponsor, who is the legally responsible entity for the importation and/or supply of the device within Australia. Sponsors must be an Australian- based legal entity. Extensive guidance on obtaining the necessary approvals to place PPE on the Australian market is available on the TGA website.36 In general, any laboratory testing, inspection, product, or management system certification has to be carried out by conformity assessment bodies accredited by the Joint Accreditation Service for Australia and New Zealand (JAS-ANZ) or by an accreditation body that is recognized under the relevant IAF MLA or ILAC MRA. 3.4 Brazil 3.4.1 Regulatory landscape for COVID-19-related PPE All PPE in Brazil is subject to approval by the Ministry of Labour and Social Security, in accordance with Regulatory Rule NR06 (mandatory by law) and PPE Ordinance 672, of November 8, 2021. This establishes the essential requirements for PPE as well as the conformity assessment procedures to be followed. Table 1 of the ordinance specifies the national and international standards that must be met to obtain a certificate of approval (CA) for the various categories of PPE. Agência Nacional de Vigilância Sanitária (Brazilian Health Regulatory Agency, or ANVISA) is the Brazilian health regulatory agency, responsible for the regulation of all medical devices. As part of the Ministry of Health and the Brazilian National Health System, it acts as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory. ANVISA issues market authorizations depending on the risk classification of the medical device. Devices are classified into four classes based on risk, with Class I being the lowest risk and Class IV the highest. In addition to approvals from the Ministry of Labour, PPE for use by medical and hospital workers is required to be registered with ANVISA, normally falling into Classes I and II. Market authorizations for products categorized as Risk Classes I and II do not expire but they can be cancelled if irregularities or fraud is detected during market surveillance activities. Although some registration requirements were relaxed at the start of the COVID-19 pandemic, the requirements were re- enforced in 2021. The National Institute of Metrology, Quality and Technology (INMETRO) acts as Executive Secretariat of the National Council of Metrology, Standardization and Industrial Quality (CONMETRO). Among its many attributes, INMETRO coordinates Brazilian government policy for both voluntary and compulsory conformity assessment activities. 36 https://www.tga.gov.au/publication/medical-device-inclusion-process. 62 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.4.2 Approach to standardization and key product standards for PPE Associação Brasileira de Normas Técnicas (Brazilian National Standards Body, or ABNT) is a non-profit organization, founded in 1940 and recognized by a governmental resolution of 1992 as Brazil’s national standards body. ABNT is a founding member of ISO and has been a member of the IEC since 1940. It is also active in the Pan-American Standards Commission and the MERCOSUL Association for Standardization, being responsible for its Executive Secretariat. A number of European and American multinational companies began manufacturing PPE in Brazil during the country’s industrialization in the 1950s, bringing with them a strong influence on the approach to standards from their home countries. However, in recent years ABNT’s policy has been for all its technical committees to follow and adopt International Standards published by ISO and the IEC where possible. When international standards do not exist or are not widely used, ABNT adopts standards such as EN or ANSI standards. Although many technical regulations in Brazil already refer to Brazilian National Standards (NBR), ABNT is beginning to play a much bigger role within the Brazilian government’s new agenda to modernize its current regulatory model. This transformation, scheduled for implementation in the 2021–2025 timeframe, is similar to the European-style approach, whereby regulations are simplified to include only essential (performance-based) requirements and there is a presumption of conformity to these technical regulations if the associated NBR standards are met. It is not yet clear to what extent these changes will affect PPE. Table 3.5 provides an overview of the main product standards for PPE in the Brazilian market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. 63 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 3.5: Overview of COVID-19-related PPE standards in the Brazilian market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) ABNT NBR 13698:2011 Respiratory protective devices—filtering half-mask to protect against particles. Based on EN 149:1992, since revised Respirators 6.1.1 ABNT NBR 13697:2010 Respiratory protective devices—particle filters. Based on EN 143:2000, since revised ABNT NBR 15052:2021 Masks for dental-medical-hospital use—requirements Medical face masks 6.1.2 and test methods Community face ABNT PR 1002:2020 Edition 2 Masks for non-professional respiratory 6.1.3 coverings protection—guide with basic requirements for testing, manufacture and use ABNT PR 1009:2021 Face protection for health care applications—guide Face shields with basic requirements for testing, manufacture and use. Based on ANSI 6.2 Z87.1:2015 Protective goggles n/a (Legislation refers to ANSI Z87.1:2015) 6.2 ABNT NBR ISO 11193-1:2015 Single-use medical examination gloves (rubber Medical latex/rubber). Identical to ISO 11193-1:2008 + AMD 1:2012, since revised 6.3.1 examination gloves ABNT NBR ISO 11193-2:2013 Single-use medical examination gloves (poly(vinyl chloride)). Identical to ISO 11193-2:2006 Surgical gloves ABNT NBR ISO 10282:2014 Single-use sterile rubber surgical gloves 6.3.2 ABNT NBR 16693:2018 Textile products for health—non-surgical gowns and Suits and coveralls private clothing used for non-surgical procedure professionals and patients— 6.4.1 requirements and test methods ABNT NBR 16693:2018 Textile products for health—non-surgical gowns and Aprons private clothing used for non-surgical procedure professionals and patients— 6.4.1 requirements and test methods ABNT NBR 16693:2018 Textile products for health—non-surgical gowns and Shoe and head — private clothing used for non-surgical procedure professionals and patients­ 6.4.1 covers requirements and test methods ABNT NBR 16064:2021 Textiles for health­ — —surgical drapes and gowns­ Gowns 6.4.2 requirements and test methods. Based on EN 13795-1:2019 3.4.3 Approach to conformity assessment Table I of the PPE Ordinance 672 (see section 3.4.1) specifies the criteria to be fulfilled in order to obtain a certificate of approval (CA) for the various categories of PPE. The CA is issued by the Ministry of Labour and Social Security after receiving a report attesting to the characteristics of the PPE in question. For products that are subject to compulsory assessment, including, for example, respirators and surgical gloves, this requires a certificate of product conformity, issued by an ISO/IEC 17065-accredited product certification body in accordance with the conformity assessment procedures defined by INMETRO, as well as providing the associated documentation and product labeling. For categories of PPE not subject to compulsory product certification, the appropriate testing has to be conducted by a national test laboratory accredited to ISO/IEC 17025. In the case of foreign manufacturers, the same requirements apply as for PPE manufactured in Brazil, with tests and certifications carried out by Brazilian laboratories and certifying bodies. Exceptions are specified in Ordinance 672, which details when tests and certifications from overseas are accepted. 64 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets It is important to remember that for any PPE used in a medical or hospital context, registration with ANVISA is also compulsory (in addition to the Certificate of Approval). The officially recognized accreditation body in Brazil for conformity assessment activities is the Brazilian National Accreditation Body (CGCRE)—an independent arm of INMETRO—which is a signatory to the ILAC MRA for laboratory testing, as well as to the IAF MLA for product and management system certification, among others. 3.5 Canada 3.5.1 Regulatory landscape for COVID-19-related PPE Health Canada (a department of the national government) defines PPE as items worn to provide a barrier to help prevent potential exposure to infectious disease. PPE sold for medical purposes in Canada are classified as medical devices. The Therapeutic Products Directorate (TPD), part of Health Canada, applies the Medical Devices Regulations under the authority of the Food and Drugs Act (1985) to ensure that the medical devices offered for sale in Canada are safe, effective, and of high quality (through Statutory Orders and Regulations, SOR 98-282). These regulations are applied to various types of PPE including medical masks, respirators, gowns, face shields, goggles, gloves, and decontamination equipment for PPE. The Canadian medical device regulations establish four classes of medical devices ranging from Class I (lowest risk) to IV (highest risk). The aforementioned types of PPE are classified as follows: • Class I: Masks, respirators, gowns, face shields. These devices are at the lowest classification because they are non-invasive • Class II: Gloves, decontamination equipment for PPE. Gloves are deemed Class II because they are non- invasive devices which can come into contact with breached skin. All medical devices, including Class I medical devices, are subject to certain general minimum safety and effectiveness requirements: • The device is designed so that it will not adversely affect the safety or health of the user or patient • Its performance does not degrade under the expected conditions of use • The device does not pose any undue risk to the user or patient, such as through flammability • Minimum labeling is provided with the device which includes the name of the device, name, and address of the manufacturer, the way the device is identified, the number of items in the package (if not evident), the expiration date, the intended use, directions for the safe and effective use, and the storage conditions. During the COVID-19 pandemic, Health Canada is also temporarily allowing certain medical devices that may not fully meet Canadian regulatory requirements but are manufactured to comparable standards to be imported and sold. This is being done through an exceptional import and sale interim order, in force as of February 21, 2022: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical- devices/interim-order-3-import-sale-medical-devices.html The use of medical devices as PPE is governed by the Canadian Centre for Occupational Health and Safety. The Centre is an independent departmental corporation under Schedule II of the Financial Administration Act (1985) and is accountable to Parliament through the Minister of Labour. There are 14 jurisdictions in Canada—one­ federal, 10 provincial and three territorial—each having its own occupational health and safety legislation, outlining the general rights and responsibilities of the employer, the supervisor, and the worker. The Centre establishes regulatory requirements at the federal level for employers to provide appropriate PPE to their employees. It also provides information about the use of PPE as a hazard control in the workplace to help protect workers from COVID-19. Similar information is generally offered by the provinces and territories. 65 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.5.2 Approach to standardization and key product standards for PPE The Standards Council of Canada (SCC) is the principal standards coordination organization within Canada. The SCC accredits standards development organizations to develop the National Standards of Canada (NSCs). It also coordinates representation of Canada on technical committees and subcommittees of the ISO and the IEC. The development of NSCs makes use of international standard development best practices and safeguards the interests of Canadians. NSCs may be nationally developed or may be adoptions of international standards. SCC-accredited standards development organizations relevant to PPE include: • ASTM International • Bureau de Normalisation du Québec (Québec Standards Bureau, or BNQ) • Canadian General Standards Board • Canadian Standards Association (CSA) Relatively few specific standards have been developed locally for COVID-19-related PPE. For this reason, Canada has relied on ASTM and ISO standards, as well as US regulatory requirements for different forms of PPE. Table 3.6 provides an overview of the main product standards for PPE in the Canadian market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 3.6: Overview of COVID-19-related PPE standards in the Canadian market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) Respirators CSA Z94.4:2018 Selection, use and care of respirators 7.1.1 Medical face masks n/a 7.1.2 Community face BNQ 1922-900:2020 Masks intended for working environments—attestation 7.1.3 coverings document (for Province of Québec) CSA Z94.3-2020 (revised May 2021) Eye and face protectors Face shields CSA Z94.3.1-2016 Guideline for selection, use, and care of eye and face 7.2 protectors CSA Z94.3-2020 (revised May 2021) Eye and face protectors Protective goggles CSA Z94.3.1-2016 Guideline for selection, use, and care of eye and face 7.2 protectors  Medical n/a 7.3.1 examination gloves Surgical gloves n/a 7.3.2 Suits and coveralls n/a 7.4.1 Aprons n/a 7.4.1 Shoe and head n/a 7.4.1 covers CSA Z314-2018 Canadian medical device reprocessing. Partially based on ANSI/ Gowns 7.4.2 AAMI PB 72 66 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 3.7 provides an overview of other accepted, referenced standards that are being directly applied to medical PPE in Canada. Table 3.7: Standards applied and referenced in Canada for COVID-19 PPE Standards development Product area Designation Title organization or authority Disposable single- use respirators US NIOSH 42 CFR Part 84 Respirator protective devices (N95) Standard specification for performance of Medical masks ASTM International F2100 materials used in medical face masks ISO 11193-1 Single-use medical examination gloves Examination gloves Specification for rubber examination gloves ASTM International D3578 (additional standards apply for gloves made of different materials) Single-use sterile rubber surgical gloves— Surgical gloves ISO 10282 specification A useful source of information is the list of specifications for COVID-19 products published by Public Services and Procurement Canada.37 3.5.3 Approach to conformity assessment Conformity assessment for COVID-19 PPE in Canada is contingent on the classification of the medical device and the referenced standard with the following provisions by device type: • Disposable single-use respirators are required to have US NIOSH approval unless exemptions are made for accepting respirators qualified to analogous standards from other regions or countries. Health Canada makes reference to CE FFP2 (EN 149-2001), P2 (AS/NZ 1716:2012), Korea 1st Class (KMOEL—2017-64), and DS (Japan JMHLW-Notification 214, 2018) as equivalent international specifications. Health Canada also references Chinese respirator-like products that include medical protective mask 95  percent efficiency (GB 19083-2010) and KN95 (GB2626-2006) • As a Class I medical device, medical masks are subject to self-declaration, with the manufacturer obliged to have evidence to support claims of conformance to ASTM F2100. This evidence can be product clearance through the US FDA. Health Canada further references Type IIR masks of EN 14683 • Eye and face wear is certified by the CSA Group as meeting CSA Z94.3.1. The CSA Group is the certification arm of CSA • Gowns are addressed similarly to medical masks in that manufacturers are able to make self-declarations of conformity but must have supporting evidence to back up such claims. Health Canada also references AAMI PB70 (US) as equivalent to CSA Z314 standard and cites EN 13795-1 for gowns and EN 14126 for coveralls • Conformity assessment requirements for masks that are used in working environments or by the general community are usually specified in terms of guidelines for their general type issued by Health Canada and by various provincial organizations. Québec Province has established a document that specifies how claims for these products must be demonstrated. All medical PPE manufacturers are subject to ISO 13485 quality management system requirements for medical devices. Manufacturers or suppliers of medical devices are also required to keep evidence of their compliance with the requirements. 37 https://buyandsell.gc.ca/specifications-for-COVID-19-products. 67 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Class II medical devices require a license to be submitted to the TPD for approval. The application for a Class II medical device requires: • A description of the medical conditions, purposes, and uses for which the device is manufactured, sold, or represented • A list of the standards complied with in the manufacture of the device to satisfy the applicable general minimum safety and effectiveness requirements • An attestation by a senior official of the manufacturer that the manufacturer has objective evidence to establish that the device meets the applicable general minimum safety and effectiveness requirements • A copy of the device label • A copy of the quality management system certificate certifying that the quality management system under which the device is manufactured meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485 “Medical devices—quality management systems—requirements for regulatory purposes,” as amended and valid. If Class I devices are imported and not labelled as described above, the importer must obtain a Medical Device Establishment Licence (MDEL) through TPD before selling the device. Alternatively, specific for COVID-19, an importer can obtain an interim order authorization for importing and selling medical devices. Specific instructions for either obtaining an MDEL through an expedited process or through the interim order authorization are provided at: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical- devices/personal-protective-equipment/authorization.html An MDEL is required for Class II medical devices (for example, medical gloves). Authorized medical devices and license holders are listed in one of the following lists or databases: • Database of Classes II, III, and IV medical devices licensed by Health Canada: https://health-products.canada.ca/mdall-limh/index-eng.jsp • Database of companies that have an MDEL: https://health-products.canada.ca/mdel-leim/index-eng.jsp In addition to these medical device databases, authorization lists related to COVID-19 medical devices have been created. This is a result of new mechanisms put in place for expedited access to COVID-19 medical devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical- devices/authorized.html Finally, it is noted that the Canadian accreditation body for conformity assessment activities is an independent arm of SCC, which is a signatory to the ILAC MRA for laboratory testing, as well as to the IAF MLA for product and management system certification, among others. 68 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.6 Colombia 3.6.1 Regulatory landscape for COVID-19-related PPE Colombia is the third-largest medical device market in Latin America, after Brazil and Mexico. According to Article 124 of Law 0009 of January 24, 1979, Colombia’s Ministry of Health and Social Protection is responsible for regulating the provision and use of both medical devices and health care-related PPE in the country. Importers of medical devices and medical PPE are required to obtain sanitary registration from the National Institute for Food and Drug Surveillance (INVIMA), which is part of the Ministry of Health and Social Protection. INVIMA requires medical devices to be approved in a founding member country of the International Medical Device Regulators Forum, formerly known as the Global Harmonization Task Force, or from a country that has an existing regulatory agreement of mutual recognition with Colombia. The Forum founding members include Australia, Canada, the EU, Japan, and the United States. Foreign manufacturers have the option to have the INVIMA registration certificate issued to their company names and maintain control over their registrations in the Colombian medical device market, so they can change the importer of record listed in the certificate, if necessary. 3.6.2 Approach to standardization and key product standards for PPE L’Instituto Colombiano de Normas Técnicas y Certificación (Colombian National Standards Body, or ICONTEC) is a private, non-profit organization that was founded on May 10, 1963, by representatives of the private sector. Since 1984, it has been recognized by the Colombian government as the national standardization body and representative of the country to the various international and regional standards organizations. The main activity of ICONTEC is the study, adoption, and promotion of technical standards in the different economic and social activities related to the private and governmental sectors in Colombia. It operates in 42 different areas of standardization and has over 162 active technical committees. In the COVID-19 context, although there are some older (pre-1990s) nationally developed Colombian standards, with a few exceptions (for example, head or shoe covers, community face coverings) most recent standards are national adoptions of regional (EN), international (ISO) or ANSI/ International Safety Equipment Association (ISEA)/ASTM standards. Further details are provided in Part 8 of this guide. ICONTEC is also the largest body for certification of management systems and products in the country providing accredited certification to ISO 9001 and ISO 13485 quality management system standards, among many others. In addition, ICONTEC runs five metrology labs that provide calibration services to industry. Table 3.8 provides an overview of the main product standards for PPE in the Colombian market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. 69 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 3.8: Overview of COVID-19-related PPE standards in the Colombian market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) NTC 3852:2020 Respiratory protective devices—filtering half-masks to protect against particles-requirements, testing, marking. Identical to EN 149:2001+A1:2009 8.1.1 Respirators NTC 6486:2020 Respiratory protective devices. For N series respirators, adopts 42 CFR part 84 requirements NTC 1733:2020 Medical face masks­ —requirements and test methods. Medical face Identical to EN 14683:2019  8.1.2 masks NTC 6436:2020 Standard specification for performance of materials used in medical face masks. Identical to ASTM F2100-20, since revised Community NTC 6449:2020 Masks (face masks) for use in environments other than the health face 8.1.3 sector coverings NTC 6493:2020 Individual eye protection. Specifications. Identical to EN 166:2001 Face shields NTC 3610:2020 Eye and face personal protection devices at work and education. 8.2 Identical to ANSI/ISEA Z87.1: 2015 NTC 6493:2020 Individual eye protection. Specifications. Identical to EN 166:2001 Protective 8.2 goggles NTC 3610:2020 Eye and face personal protection devices at work and education. Identical to ANSI/ISEA Z87.1: 2015, since revised NTC-ISO 11193-1:2020 Single-use medical examination—Part 1: Specification for Medical gloves made from rubber latex or rubber solution. Identical to ISO 11193-1: 2008 (since examination revised)  8.3.1 gloves NTC-ISO 11193-2:2020 Single-use medical examination gloves. Part 2: Specification for gloves made from poly(vinyl chloride). Identical to ISO 11193-2:2006 Surgical n/a 8.3.2 gloves NTC 6434:2020 Protective clothing. Requirements and test methods for clothing protection against biological agents. Identical to EN 14126:2003 (current) NTC-EN 14605:2020 Protective clothing against liquid chemicals. Requirements performance for clothing with liquid-tight seams (Type 3) or with spray-tight joints Suits and (Type 4), including garments that offer protection only to certain parts of the body 8.4.1 coveralls (Types PB [3] and PB [4]). Identical to EN 14605:2005+A1:2009 (current) NTC-EN 13034:2020 Protective clothing against liquid chemicals. Requirements performance for chemical protective clothing that offers protection limited against liquid chemicals (Type 6 and PB [6] equipment). Identical to EN 13034:2005+A1:2009 (current) NTC 6434:2020 Protective clothing. Requirements and test methods for clothing protection against biological agents. Identical to EN 14126:2003 (current) NTC-EN 14605:2020 Protective clothing against liquid chemicals. Requirements performance for clothing with liquid-tight seams (Type 3) or with spray-tight joints (Type 4), including garments that offer protection only to certain parts of the body Aprons 8.4.1 (Types PB [3] and PB [4]). Identical to EN 14605:2005+A1:2009 (current) NTC-EN 13034:2020 Protective clothing against liquid chemicals. Requirements performance for chemical protective clothing that offers protection limited against liquid chemicals (Types 6 and PB [6] equipment). Identical to EN 13034:2005+A1:2009 (current) Shoe and NTC 6457:2020 Disposable hats/caps 8.4.1 head covers NTC 6451:2020 Disposable foot covers NTC 5623:2020 Surgical drapes and sheets. Requirements and test methods. Part 1: Gowns 8.4.2 Surgical drapes and gowns. Identical to EN 13795-1:2019 70 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.6.3 Approach to conformity assessment Under its Act No. 3 of March 24, 2020, INVIMA facilitated the supply of certain products related to the prevention, diagnosis, and treatment of COVID-19, due to the risk of shortages. This includes the following products, which do not require health registration for as long as the state of national emergency is maintained: • Protective glasses • Latex and nitrile gloves • Sterile gloves • N95 masks and FFP2 or FFP3 respirators • Filter masks • Full or partial body protection: gowns, caps, sterile surgical clothing, surgical fields, operative field, sheets, covers, biohazard suits, leggings, and metatarsal protectors • Facial protectors: masks or visors • Disposable face masks • Bioprotection suits (blouse and pants or coveralls) INVIMA will grant authorization for the importation and manufacture of these products as long as the following requirements are met: Import requirements • A request is submitted to INVIMA with information of the manufacturer, country of origin of the product, and data of the authorized representative, if applicable • List of products to be imported, including their date of manufacture • Free sale certificate from the country of origin, or equivalent document or certification issued by the health authority. Interested parties may provide the link of the health entity so that INVIMA can verify their marketing authorization in that country. Manufacturing requirements • Submit the request to INVIMA along with the manufacturer’s information (name, address, email, and telephone) • Provide the list of products to be manufactured • List the specific national or international technical standards that have been used in the manufacturing process • Carry out a self-assessment of compliance with the requirements indicated in the technical annex of Resolution 522 of 2020, through the INVIMA’s website. The officially recognized accreditation body in Colombia is Organismo Nacional de Acreditación de Colombia (Colombian National Accreditation Body, or ONAC). ONAC is a non-profit corporation, constituted in 2007 under Colombian laws within the framework of the Civil Code. Its main objectives are to accredit the technical competence of conformity assessment bodies, to act as a monitoring authority in the Organisation for Economic Co-operation and Development’s good laboratory practices, and to perform the functions of the national accreditation body in accordance with the designation contained in Chapter 26 of Decree 1074 of 2015. ONAC is a signatory of the ILAC MRA for accreditation of ISO/IEC 17025 and ISO 15189 and the IAF MLA for product and management system certification. 71 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.7 India 3.7.1 Regulatory landscape for COVID-19-related PPE In India, COVID-19-related PPE generally falls within the scope of the Medical Device Rules (2017). For the last few years, the medical devices sector in India has been transitioning from being largely unregulated to a regulated regime. Since the late 1980s, medical devices have been regulated by the Central Drug Standard Control Organization (CDSCO) by notifying them as “drugs” under the Drugs & Cosmetics Act (1940). An important recent development was the issue of the Medical Devices Rules (MDR) in 2017 which aligned more closely with international practices and classified medical devices based on risk, as follows: • Low risk—Class A • Low-moderate risk—Class B • Moderate-high risk—Class C • High risk—Class D These rules have been effective from January 1, 2018, but are applied only to specific “notified” medical devices, still leaving a large number of devices unregulated. In order to allow for more general application and a transition time for industry, further notifications, issued on February 11, and September 3, 2020, laid out the timelines for phased implementation of regulation for specific device categories and provided a formal definition of “non-notified medical devices.”38 Included in Category 12 of this latter classification are various forms of PPE, among them: • Face shields, particular respirator (sic), latex and non-latex medical examination gloves, gowns/ coveralls (all considered as Class A medical devices) • Nitrile gloves, latex, and non-latex surgical gloves (Class B) The situation on medical PPE was clarified with a notice issued by CDSCO on September 13, 2021, “Classification of medical devices pertaining to PPE under the provisions of Medical Device Rules, 2017- Reg.” which provides the following classification: Table 3.9: Classification of PPE as per the Medical Devices Rules (2017)—India Risk Medical device name class Face shield A Surgical gloves (latex or non-latex) B Medical examination gloves (latex or non-latex) A Surgical/isolation gowns (non-sterile), patient gowns, professional examination gowns A Surgical/isolation gowns (sterile) B Face masks and/or respirators (included in an overall “PPE” listing) B In the notice the intended use of the above medical device types is also provided. The transition plan for the MDR currently requires all Class A and Class B medical devices to comply with the MDR 2017 by September 30, 2022, and Class C and D devices by September 30, 2023. 38 CDSCO (Medical Device Division) . September 3, 2020. File No 29/Misc/03/2020/DC(200). 72 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.7.2 Approach to standardization and key product standards for PPE Historically, India’s portfolio of standards was based largely on British Standards. Independent national standardization activity started in 1947 with the establishment of the Indian Standards Institution (ISI) and in 1952 an Act of Parliament also gave to ISI the responsibility of operating a certification marking scheme. The Bureau of Indian Standards (BIS) Act was approved in 1986 and ISI was superseded by BIS on April 1, 1987. The BIS Act has since been revised in 2016. BIS standards have subsequently evolved to become closely aligned with the European and international standards published by CEN and ISO respectively, both in terms of product standards and test methods. The need for this approach was further reinforced in 1995, when India joined the WTO (see Part 1 of this guide.) The Indian standards portfolio for PPE is mature and extensive. The process of adopting ISO or even EN test methods has been used extensively, although the links are often not obvious from the standards numbering process. The link is usually contained within the standard foreword and not reflected by adopting or prefixing the foreign standard number, as is common in many other economies. BIS standards, other than those which are adoptions of ISO/IEC standards, are available as free downloads at https://standardsbis.bsbedge.com/ The EU standards are themselves largely moving to an ISO standard base for PPE within the next few years and work will be required by BIS to ensure that this alignment is maintained. According to a recent UK government report,39 “to achieve alignment with the largest sector of global economies, the Indian standards landscape therefore needs to decide whether to align with the USA or to the rest of the ISO world. This may present some difficulties in the supply chain for materials, where ASTM standards are often used to qualify materials, which then require additional testing to ISO standards. ISO is the direction that the majority of economies are currently travelling in.” The report goes on to make the following recommendations: • A more general adoption of current ISO-based headline product standards that are either in use in Europe or being introduced within the next few years • To continue the process of adopting ISO test methods in support of the headline product standards • To provide clearer definitions between protective and medical products and the relevant standards, ensuring that both single-approach (PPE or medical device) and dual-use product requirements are clearly defined • The more extensive use of prefixing existing ISO standard numbers in order to make adopted standards more obvious to the whole supply chain. This may require additional agreements between BIS and other standard-issuing bodies. The MDR prescribes the use of product standards as follows: • Sub-rule 1The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act (No. 63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time • Sub-rule 2 Where no relevant standard of any medical device has been laid down under Sub-rule 1, such device shall conform to the standard laid down by the International Organization for Standardization (ISO) or the International Electrotechnical Commission (IEC), or by any other pharmacopoeial standards • Sub-rule 3 In the case of standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer’s standards. The quality management systems required for medical device manufacturers are based on ISO 13485:2003 and not the latest (2016) version. This means that manufacturers have to seek certification to ISO 13485:2016 in order to achieve international recognition but also comply with the older (2003) version for compliance to MDR. 39 UK Foreign, Commonwealth and Development Office. March 2021. Report on UK-India Ease of Doing Business Programme PPE Project. 73 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets The overall situation was somewhat complicated at the beginning of the COVID-19 pandemic. In March 2020, emergency guidelines for PPE published by the Ministry of Health prescribed the use of foreign or international standards for PPE (and not BIS standards as prescribed in the MDR), but without defining how conformity to these standards should be demonstrated. The Ministry of Textiles, which took the responsibility of ramping up production of many categories of PPE, also took the initiative of installing a system of certifying the quality of coveralls by testing in designated laboratories. It subsequently advised PPE manufacturers to obtain BIS certification which resulted in the implementation of BIS standards in the PPE industry (not all of which are aligned to international standards), despite Ministry of Health guidelines not referencing them. This situation continues (Q4 2021), and BIS certification is being required for public procurement. Table 3.10 provides an overview of the main product standards for PPE in the Indian market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 3.10: Overview of COVID-19-related PPE standards in the Indian market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) IS 9473:2002 (reaffirmed 2019) Respiratory protective devices—filtering half- masks 9.1.1 Respirators to protect against particles—specification. Based on EN 149:1991 version (since revised) Medical face IS 16289:2014 (reaffirmed 2019) Medical textiles—surgical face masks—specification  9.1.2 masks Community n/a 9.1.3 face coverings IS 5983:1980 (reaffirmed 2018) Specification for eye protectors. Based on ISO 4849, since replaced by ISO 16321-1  Face shields 9.2 IS 8521-1:1977 (reaffirmed 2018) Specification for industrial face shields—Part 1—with plastic visor Protective IS 5983:1980 (reaffirmed 2018) Specification for eye protectors. Based on ISO 4849, 9.2 goggles since replaced by ISO 16321-1  IS 15354-1:2018 Single-use medical examination gloves—Part 1: Specification for gloves made from rubber latex or rubber solution. Identical to ISO 11193-1: 2008 (since revised) Medical IS 15354-2:2018 Single-use medical examination gloves—Part 2: Specification for examination gloves made from poly(vinyl chloride). Identical to ISO 11193-2: 2006 9.3.1 gloves IS 6994-7:2021 Protective gloves—general requirements and test methods. Identical to ISO 21420:2020  IS 6994-5: 2021 Protective gloves against dangerous chemicals and micro- organisms—requirements for micro-organisms risks. Identical to ISO 374-5:2016 IS 13422:1992 (reaffirmed 2018) Disposable surgical gloves specification. Based on ASTM D3577-88 (since revised) Surgical gloves IS 6994-7:2021 Protective gloves—general requirements and test methods. Identical 9.3.2 to ISO 21420:2020  IS 6994-5: 2021 Protective gloves against dangerous chemicals and micro- organisms—requirements for micro-organisms risks. Identical to ISO 374-5:2016 74 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Suits & IS 17423:2021 Medical textiles—bio-protective coveralls—specification 9.4.1 coveralls Aprons n/a 9.4.1 Shoe and Head n/a 9.4.1 covers Gowns IS 17334:2019 Medical textiles—surgical gowns and surgical drapes— specification 9.4.2 3.7.3 Approach to conformity assessment Registration to provide products covered by the MDR—including the PPE mentioned in Category 12 of the CDSCO September 2020 Notice—is a temporary measure, as a step toward licensing. After the transition is complete this will require manufacturers to implement a quality management system as per its schedule 5 (based on old version of ISO 13485) and demonstrate compliance to product standards as specified in the MDR. It important to note that during this transition period neither compliance to the MDR nor to the product standards mentioned therein is legally mandated. The officially recognized accreditation bodies in India for conformity assessment activities are the National Accreditation Board for Certification Bodies (NABCB) for product and management system certification, among others, and the National Accreditation Board for Testing and Calibration Laboratories (NABL). Both are entities under the Quality Council of India and signatories to the IAF MLA and ILAC MRA respectively. MDR prescribes audits by notified bodies for classes A and B devices and audits by the regulator for classes C and D devices. The notified bodies are required to be accredited by NABCB. The list of notified bodies can be seen on the website of the CDSCO.40 3.8 Jordan 3.8.1 Regulatory landscape for COVID-19-related PPE The fundamental provisions for occupational safety and health matters in Jordan are defined in Chapter 9 of the 1996 Labour Law and its amendments. The Occupational Health and Safety Directorate41 of the Ministry of Labour oversees its implementation, with attributions that include ensuring the provision of a healthy, safe, and decent work environment in all sectors and professions by raising awareness and compliance with standards and best practices related to occupational safety and health. However, its activities do not cover the regulation of medical-related PPE, most of which is regulated as medical devices by the Jordan Food and Drug Administration (JFDA) under the Ministry of Health and/or covered by “mandatory standards” issued by the Jordan Standards and Metrology Organization (JSMO). The Drug and Pharmacy Law No 12 of 2013 and its associated regulations and directives, consider medical devices as part of “medical supplies,” which are defined as being “all devices, means, substances, tools, items or reagents and calibrators, including the software required for their operation, whether used alone or in association with another, that are intended by the manufacturer for human use for achieving any of the following purposes: […] diagnosis, prevention, supervision, treatment, or reduction of diseases […].” All are administered by the Medical Devices & Supplies Directorate of the JFDA. Most of the medical PPE in this guide is classed as low risk (Class I)42 in a classification system that closely mirrors that of the EU.43 Only surgical masks are considered as low-to-moderate risk (Class IIa). While products falling under Classes I and IIa do not require registration, any products that are deemed as 40 https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/ListofNotifiedmd.pdf. 41 http://www.mol.gov.jo/EN/Pages/Occupational_Safety_and_Health_Directorate. 42 https://www.regdesk.co/resource-library/jordan/. 43 https://www.who.int/medical_devices/countries/regulations/jor.pdf?ua=1. 75 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets medical devices need to be approved for import by the JFDA and must comply with certain conditions that mainly pertain to the documents required for import purposes, as well as the information that must be included on labels and inner and outer packaging. 3.8.2 Approach to standardization and key product standards for PPE The JSMO is the national standards body and was established as a public organization according to the Standards and Metrology Law (1994 and 2000). The JSMO issues two types of standards: • Technical standards: Mandatory standards that are based on international benchmarks and agreements. These standards cover products that effect consumers’ health and safety, such as food products, chemical detergents, electrical equipment, and “personal safety equipment.” Technical standards are published in the Jordan Official Gazette in hard copy only and are registered in the Jordan Quality Mark database. • Standard specifications: Optional (voluntary) standards for manufacturers and importers. Examples include furniture products, clothes, textiles, and shoes. Some companies choose to set their own standard specification, adding special features or qualities. In its role to strengthen the national quality infrastructure for products and services and align Jordanian national standards with international best practices, the JSMO is focusing on PPE as a priority sector and in response to an urgent national need. In addition to its role in standardization, the JSMO also conducts the following activities: • Supervision of the national system for metrology in Jordan aiming to maintain the national measurement standards and assure traceability to SI Units, in cooperation with the Jordan National Metrology Institute • Certification, including product conformity certificates such as the Jordan Quality Mark Certificate, Local Conformity Certificate, Conformity Certificate for Export Purposes and others. The process to receive a quality mark is divided into four stages: application procedure, assessment procedure, certification procedure, and surveillance procedure • Market surveillance to verify conformity of imported products and products placed on the market with mandatory technical regulations • Managing the WTO/TBT Enquiry Point and providing information services to economic operators. Table 3.11 provides an overview of the main product standards for PPE in the Jordanian market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. 76 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 3.11: Overview of COVID-19-related PPE standards in the Jordanian market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) JS 1943:2011 Respiratory protective devices -filtering half-masks to protect Respirators against particles-requirements, testing, marking. Identical to EN 149:2001 (since 10.1.1 amended) Medical face JS 1745:2007 Disposable surgical masks-requirement and test methods. Based on 10.1.2 masks EN 14683:2005 (since revised) Community face n/a (under development) 10.1.3 coverings Face shields JS 268:2008 Personal eye protection—specifications. Identical to EN 166:2001 10.2 Protective JS 268:2008 Personal eye protection—specifications. Identical to EN 166:2001 10.2 goggles JS 809 series (Medical gloves for single use)  JS 809-1:2005 Requirements and testing for freedom from holes. Identical to EN 455-1:2000 (since revised) Medical JS 809-2: 2014 Requirements and testing for physical properties. Identical to EN examination 455-2:2009 (since revised) 10.3.1 gloves JS 809-3: 2014 Requirements and testing for biological evaluation. Identical to EN 455-3: 2006 (since revised) JS 809-4: 2014 Requirements and testing for shelf-life determination. Identical to EN 455-4: 2009 JS 809 series (Medical gloves for single use)  JS 809-1:2005 Requirements and testing for freedom from holes. Identical to EN 455-1:2000 (since revised) JS 809-2: 2014 Requirements and testing for physical properties. Identical to EN Surgical gloves 455-2:2009 (since revised) 10.3.2 JS 809-3: 2014 Requirements and testing for biological evaluation. Identical to EN 455-3: 2006 (since revised) JS 809-4: 2014 Requirements and testing for shelf-life determination. Identical to EN 455-4: 2009 JS 1899:2009 Protective clothing for protection against chemicals—classification, Suits and labeling, and performance requirements. Identical to ISO 16602:2007 (since 10.4.1 coveralls amended) JS 1899:2009 Protective clothing for protection against chemicals—classification, Aprons labeling, and performance requirements. Identical to ISO 16602:2007 (since 10.4.1 amended) Shoe and head n/a 10.4.1 covers JS 983-1:2007 Surgical drapes, gowns, and clean air suits, used as medical devices, for patients, clinical staff, and equipment—Part 1: General requirements for manufacturers, processors, and products. Equivalent to EN 13795-1:2002 (since revised) JS 983-2:2007 Surgical drapes, gowns, and clean air suits, used as medical devices, for patients, clinical staff, and equipment—Part 2: Test methods. Equivalent to EN 13795- Gowns 10.4.2 2:2002 (since revised) JS 983-3:2008 Surgical drapes, gowns, and clean air suits, used as medical devices, for patients, clinical staff, and equipment—Part 3: Performance requirements and performance levels. Equivalent to EN 13795-3:2006, since merged with EN 13795-1 and EN 13795-2 77 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.8.3 Approach to conformity assessment All imported goods subject to mandatory standards require verification through laboratory testing in Jordan. The JSMO undertakes these responsibilities by cooperating with approved laboratories, including those at the JSMO, Ministry of Health, Greater Amman Municipality, Ministry of Agriculture and Royal Scientific Society, all of which perform inspection and testing. The Ministry of Health sets technical rules and specifications applicable to all medical equipment to ensure that all such products being sold to Jordanian end users meet the requirements of safety and quality. Public sector tenders do not require regulatory review if the product has been authorized for marketing in the United States, Europe, or Japan. Other specifications are stipulated in the tender terms on a case-by-case basis. Pre-market approval is mandatory for all medical devices; suppliers are required to: • Appoint an authorized representative in Jordan to submit the application • Fill out the application form and submit all required documents: • Certificate of free sale (CFS) • Quality system certification (standard not specified) • Declaration of conformity • Description of device and intended use. If approved, the applicant will receive a registration certificate. Medical equipment procured by the public sector is tested either by the beneficiary itself (that is, Ministry of Health, Royal Medical Services, and so on) or the Royal Scientific Society. This testing is not applicable to medical equipment procured by the private sector, which is not subject to any prescribed testing procedures. The JFDA may prohibit the import of a product, cease its sale or distribution, ban its marketing, suspend or revoke its registration, or recall it if: • The product is found to be toxic, of inferior quality, ineffective, or of less than the required efficacy, pursuant to a report from the WHO, the manufacturer or other entity accredited by the JFDA • It proves that it is not permissible to market the product or that its marketing has been suspended in the country that was relied on for its registration • It was registered based on incorrect information • Certain variations on the product that require renewal of the registration were made without that renewal • Certain variations on the product that require prior approval were made without obtaining that approval. The officially recognized accreditation body for Jordan is the Accreditation Unit of the Jordanian Accreditation and Standardization System (JAS-AU) which is hosted by, but is independent from, the JSMO. All certificates of accreditation issued by the JAS-AU for testing laboratories, calibration laboratories, and medical laboratories are recognized and accepted worldwide as a result of its full membership of the Arab Accreditation Cooperation (ARAC) and ARAC’s subsequent admission to the ILAC MRA in 2017. The JAS-AU’s scope that is covered by the ARAC multilateral arrangement includes the following: • Calibration laboratories ISO/IEC 17025 • Testing laboratories ISO/IEC 17025 • Medical/clinical laboratories ISO 15189 • Inspection ISO/IEC 17020 • Product certification ISO/IEC 17065. 78 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.9 Kenya 3.9.1 Regulatory landscape for COVID-19-related PPE General occupational safety and health legislation in Kenya can be traced back to the Factories’ Ordinance Act (1950) which gradually evolved over time to become the Occupational Safety and Health Act (2007), still in force today. The Directorate of Occupational Safety and Health Services within the Ministry of Labour, Social Security and Services is responsible for the oversight and enforcement of the provisions of the act, which requires all government sectors to develop policies and guidelines to support it. The Ministry of Health is the lead health care policy-setting institution in Kenya and published its “Occupational safety and health policy guidelines for the health sector in Kenya” in July 2014. The Pharmacy and Poisons Board, an agency under the Department of Medical Services at the Ministry of Health, is the regulatory body for registration of medical devices, including PPE. On February 28, 2020, President Uhuru Kenyatta established a new committee to guide the response to COVID-19. This committee, chaired by the Cabinet Secretary for Health, was tasked with coordinating the country’s COVID-19 preparedness, prevention, and response. In particular, this committee is responsible for coordinating capacity building of medical professionals, enhanced surveillance at points of entry, preparation of isolation and treatment facilities, medical supplies, and PPE. Table 3.12 shows the various categories of PPE and their application that have been defined for healthcare workers in the fight against COVID-19. Table 3.12: Risk categories for PPE to be provided to health care workers44 PROTECTION LEVEL PROTECTIVE EQUIPMENT SCOPE OF APPLICATION • Disposable surgical mask • Triage LEVEL 1 PROTECTION • Facility uniform • Outpatients’ clinic • Gloves • Private clinics • Facility uniform • COVID-19 clinics • N95 mask • Isolation wards and CCU • Caps • Radiology unit for confirmed COVID-19 • Waterproof surgical gowns patients LEVEL 2 PROTECTION • Gloves • Decontamination and cleaning unit (public • Eye protection e.g., face shield or health) goggles • Laboratory • Plastic apron • Farewell home • Disposable scrubs • N95 mask • During suctioning • Waterproof surgical gowns • Intubation LEVEL 3 PROTECTION • Plastic apron • Bronchoscopy • Face shield or goggles if available • Surgery • Caps • Endoscopy or colonoscopy • Gloves 3.9.2 Approach to standardization and key product standards for PPE The Kenya Bureau of Standards (KEBS) is a statutory body established under the Laws of Kenya Standards Act (2012), Chapter 496. The aims and objectives of the Bureau include preparation of standards relating to products, measurements, materials, processes, and so on, and their promotion at national, regional, and international levels, certification of industrial products, assistance in the production of quality goods, improvement of measurement accuracy, and circulation of information relating to standards. KEBS is also mandated to offer quality inspection of imports based on Kenya Standards or other approved specifications. KEBS has remained the premier government agency for the provision of standards, metrology, and conformity assessment services since its inception in 1974. Over that period, its main activities have grown from the development of standards and quality control for a limited number of locally made products in the 1970s to the provision of more comprehensive standards development, metrology, conformity assessment, 44 Republic of Kenya, Ministry of Health. 2021. Guidelines on Case Management of COVID-19 in Kenya. 79 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets training, and certification services. With the re-establishment of the East African Community and Common Market for Eastern and Southern Africa, KEBS activities now include participation in the development and implementation of standards, metrology, and conformity assessment activities at the regional level where it participates in the harmonization of standards, measurements and conformity assessment regimes for regional integration. KEBS also operates the National Enquiry Point in support of the WTO/TBT Agreement. Table 3.13 provides an overview of the main product standards for PPE in the Kenyan market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 3.13: Overview of COVID-19-related PPE standards in the Kenyan market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) KS 2409-6:2018 Health care wastes management commodities. Specification— Respirators Part 6: Filtering face masks to protect against particles. Based on (but not identical 11.1.1 to) EN 149:2001, since amended Medical face KS 2636:2021 Medical face masks—specification. Based on (but not identical to) EN 11.1.2 masks 14683:2019 Community KS 2924:2020 Personal protective equipment—face masks­ —masks for public use— 11.1.3 face coverings specification Face shields KPAS 2919:2020 Personal protective equipment—face shield—specification 11.2 Protective KS 2409-8:2018 Health care wastes management commodities. Specification— 11.2 goggles Part 8: Safety goggles. References ISO 4849, since replaced by ISO 16321-1 KS ISO 11193-1:2020 Single-use medical examination gloves —Part 1: Specification Medical for gloves made from rubber latex or rubber solution. Identical to ISO 11193-1:2008 examination with AMD1: 2012, since revised  11.3.1 gloves KS ISO 11193-2:2006 Single-use medical examination gloves. Part 2: Specification for gloves made from poly(vinyl chloride). Identical to ISO 11193-2:2006, current KS ISO 10282:2014 Single-use sterile rubber surgical gloves. Identical to ISO Surgical gloves 11.3.2 10282:2014, current KS ISO 13688:2013 Protective clothing—general requirements. Identical to ISO Suits and 13688:2013, since amended. 11.4.1 coveralls KS 2409-07:2018 Health care wastes management commodities. Part 7: Overall clothing—specification KS 2409-3:2018 Health care wastes management commodities. Specification— Aprons 11.4.1 Part 3: Plastic apron Shoe and head n/a 11.4.1 covers Gowns n/a 11.4.2 80 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.9.3 Approach to conformity assessment Public procurement for both medical equipment (including PPE) and pharmaceuticals is performed by the Kenya Medical Supplies Agency (KEMSA), a state corporation and a specialized medical logistics provider for the Ministry of Health. KEMSA typically uses open international tenders, open national tenders limited to local Kenyan suppliers only, restricted tenders, or direct procurement from government agencies to source products. All public tenders are advertised on the KEMSA website and must follow the Public Procurement Act (2015). All imported products require a certificate of conformity (CoC) for customs clearance at the border, applicable for each consignment, and importers are required to obtain the CoC for their goods before applying for import permits from the Pharmacy and Poisons Board through the Kenya National Single Window Electronic (KenTrade) System. In September 2017, Kenya incorporated all medical devices, food supplements, medical cosmetics, herbal products, and other allied borderline health care products into the Pre-Export Verification of Conformity program. This is a conformity assessment program applied to products at the respective exporting countries, to ensure their compliance with the applicable Kenyan technical regulations and mandatory standards or approved specifications. Products must demonstrably meet requirements before they can be exported to Kenya. Non-compliant goods will be denied entry. The program is operated by accredited third-party inspection companies in 19 different geographical regions on behalf of KEBS. The basis of certification is the relevant Kenya standards or approved specifications, and can include: • Physical inspection prior to shipment • Sampling, testing, and analysis in accredited laboratories • Audit of production processes • Documentary check of conformity to regulations • Assessment of conformity to Kenyan Standards. The officially recognized accreditation body for Kenya is the Kenya Accreditation Service (KENAS), established in 2009 to carry out accreditation of conformity of assessment services including calibration, product testing, medical testing (pathology) and proficiency testing laboratories, inspection, verification, and certification bodies in all economic sectors. It is a state corporation re-established by the Kenya Accreditation Service Act (No. 17 of 2019) as the sole national accreditation body for Kenya. KENAS is responsible to the Ministry of Industry, Trade and Enterprise Development with a broad objective to strengthen the conformance to standards technical infrastructure and to build confidence in Kenyan products and services locally and globally. KENAS contributes to Kenya’s development agenda by promoting the use of accreditation and the acceptance of equivalence of accredited bodies worldwide as means for facilitating trade, enhancing economic outcomes, managing and mitigating risks to quality, health, safety, environment, and consumer protection. KENAS is also the designated member and representative for Kenya for regional and international accreditation. Since 2017, KENAS has been a full signatory to the mutual recognition arrangements (MRAs) with the African Accreditation Cooperation (AFRAC), the IAF and ILAC. 81 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.10 Malaysia 3.10.1 Regulatory landscape for COVID-19-related PPE PPE intended for use in health care facilities or for the prevention of transmission of disease falls within the scope of the Medical Devices Act (2012) (Act 737) and is regulated as medical devices in Malaysia. The regulation of medical devices is carried out by the Medical Device Authority (MDA) of the Ministry of Health (www.mda.gov.my). The act has been further detailed by the Medical Device Regulations 2012 and other regulations issued later on specific topics. The MDA has issued several guidance documents available at https://www.mda.gov.my/doc-list/guidance-document.html. PPE within the scope of this guide is considered as Class A (low risk) medical devices, therefore the involvement of a “registered conformity assessment body” (similar to a “notified body” in the EU) is not necessary. It is also worth mentioning that PPE for non-medical uses (that is, industrial, construction, chemical protection, and so on) is regulated under the Occupational Safety and Health Act 1994 (Act 514) and regulations issued under it. Such PPE must be approved by the Department of Occupational Safety and Health (https://www.dosh.gov.my/index.php#) under the Ministry of Human Resources. 3.10.2 Approach to standardization and key product standards for PPE The national standards body of Malaysia is the Department of Standards Malaysia (DSM), under the Ministry of International Trade and Industry, https://www.jsm.gov.my/. The DSM represents Malaysia in the ISO, IEC, and the regional organizations involved in standardization activities including the Asia- Pacific Economic Cooperation Sub-Committee on Standards and Conformance (APEC-SCSC) and the ASEAN (Association of Southeast Asian Nations) Consultative Committee for Standards & Quality. Malaysian standards related to COVID-19 are freely available online at https://www.jsm.gov.my/relevant- standards-related-to-covid-19-pandemic and at the MySOL platform, launched in 2021 at https://msonline. jsm.gov.my/ The following MDA Guidance Documents are relevant to medical PPE: • MDA/GD/0058 (September 2021)—personal protective equipment (PPE)—requirements • MDA/GD/0033 (October 2021)—medical face mask and respirator Table 3.14 provides an overview of the main product standards for PPE in the Malaysian market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. 82 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 3.14: Overview of COVID-19-related PPE standards in the Malaysian market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) MS 2323:2010 Respiratory protective devices—filtering half-masks to protect against Respirators 12.1.1 particles—­requirements, testing, and marking. Identical to EN 149:2001, since amended Medical face MS EN 14683:2021 Medical face masks—requirements and test methods. 12.1.2 masks Identical to EN 14683:2019  Community face n/a 12.1.3 coverings Face shields n/a 12.2 Protective n/a 12.2 goggles MS 2299-1:2010 Medical gloves for single use—Part 1: Requirements and testing for Medical freedom from holes. Identical to EN 455-1:2000, since revised  examination 12.3.1 MS 2299-3:2010 Medical gloves for single use­ —Part 3: Requirements and testing for gloves biological evaluation. Identical to EN 455-3:2006, since revised MS 2299-1:2010 Medical gloves for single use—Part 1: Requirements and testing for Surgical freedom from holes. Identical to EN 455-1:2000, since revised  12.3.2 gloves MS 2299-3:2010 Medical gloves for single use—Part 3: Requirements and testing for biological evaluation. Identical to EN 455-3:2006, since revised Suits and MS ISO 13688:2020 Protective clothing —general requirements. Identical to ISO 12.4.1 coveralls 13688:2013, since amended  MS ISO 13688:2020 Protective clothing—general requirements. Identical to ISO Aprons 12.4.1 13688:2013, since amended  Shoe and MS ISO 13688:2020 Protective clothing—general requirements. Identical to ISO 12.4.1 head covers 13688:2013, since amended  Gowns n/a 12.4.2 It can be seen from Table 3.14 that Malaysian standards exist for several, but not all, PPE types and these are adaptations of EN or ISO standards (not always aligned with the latest versions). Even when they are available, the Malaysian standards are not always referred to in the MDA Guidance Documents. For the purpose of complying with medical device regulations, standards from the United States and the EU are generally accepted. Table 3.15 provides some specific examples. 83 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 3.15: Other (non-Malaysian) PPE standards accepted by the MDA PPE type Accepted performance standards Comments EN 14683:2019 (type I or II) or MDA accepts any equivalent Procedure mask/ respirators ASTM F2100-19 (level 1) or standard giving comparable performance YY/T 0969 (BFE≥95%) Not medical devices, added for Respiratory protection devices --- completeness EN 14683:2019 (type IIR) or MDA accepts any equivalent Surgical mask/respirators/fluid- ASTM F2100-19 (level 2 or 3) or standard giving comparable resistant surgical masks performance YY/T 0469 (BFE≥98%) Not medical devices; added for completeness. Community face coverings --- The Ministry of Domestic Trade and Consumers Affairs is in the process of regulating based on MS EN 14683 requirements EN 166 Face shield/goggles For irritation ISO 10993-10:2010 or ISO 10993-23:2021 EN 455-2 and -4 have not been ISO 11193-1:2020 (rubber) or adopted as Malaysian standards. EN 455 series or (depending on material) Medical examination gloves ASTM D6319, ASTM D3578, ASTM D5250, (non-sterile) AST D6977 or alternative equivalent set of standards ISO 10282 or EN 455 series or Surgical gloves (sterile) ASTM D3577 For sterility EN ISO 11607-1:2019 or alternative equivalent set of standards EN 14126, ISO 16603, ISO 16604, ISO 22610 Coveralls and ISO 22612 Non-surgical gowns ANSI/AAMI PB70, level 1 or 2 or EN 13795-1 ANSI/AAMI PB70, level 3 or 4 (recommended) or EN 13795-1 Surgical gowns/isolation gowns Also, if sterile, EN 556-1, or alternative equivalent set of standards Standards as above for coveralls For tear resistance EN ISO 7765-1, EN ISO Aprons 6383-2 If biodegradable, EN 13432 or ASTM D6400 Standards as above for coveralls Head/shoe covers If biodegradable, EN 13432 or ASTM D6400 84 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.10.3 Approach to conformity assessment The manufacturer, or its authorized representative in Malaysia, must apply to the MDA in order to register their medical devices and must submit for review a declaration of conformity. The application must include a full test report for the product and (if it is to be supplied sterile) the sterilization process validation report— see Guideline Document MDA/GL/MD-01 (June 2014). Also, a technical documentation file must be prepared and made available on request. The file must be in the Common Submission Dossier Template (CSDT) format and contain evidence of conformity of the medical device to the relevant essential principles of safety and performance contained in the legislation—see Guidance Document MDA/GD/0008 (March 2014). For Class A medical devices such as medical PPE, no involvement of an external conformity assessment body is required, although the manufacturer must establish a quality management system according to ISO 13485 and a post-market surveillance system (see Table 3.16). Table 3.16: Conformity assessment requirements for Class A medical devices Conformity assessment Manufacturer/representative responsibility Conformity assessment requirement element a) Establish and maintain a full quality management system or may exclude design and development controls, process control and Quality inspection and testing; and/or Pre-market and regulatory audit not management b) Keep evidence (validation report) on the aspect required system of manufacture concerned with securing and maintaining sterile condition if the medical device is to be supplied sterile a) Establish and maintain post-market surveillance system b) Record and evaluate reports of adverse events Pre-market and regulatory audit not c) Document, maintain and implement: Post-market required i. Complaint handling surveillance ii. Distribution records system Regulatory audits may be conducted as iii.Mandatory problem/adverse event deemed necessary by the authority reporting iv. Field corrective action v. Recall Pre-market submission of CSDT Prepare summary of technical documentations not required. May be requested Technical (refer to MDA/GD/0008: CSDT) and have available by the authority for the purpose documentation for review on request of investigating specific safety or regulatory concerns Manufacturer/representative to submit Declaration of Prepare declaration of conformity as per specified during registration process, keep on file conformity in MDA/GD/0025 and present on request by the authority From 1st June, 2021, PPE for applications such as respiratory protection (particulate filters) and body protection must obtain certification from an approved accredited conformity assessment body. Initially, the only body that is approved is SIRIM QAS International Sdn. Bhd (https://www.sirim-qas.com.my/our-services/ product-certification/personal-protection-equipment-scheme/), but more are expected to be added to the list in the future. The same requirement will hold for personal eye protection and gloves after 1st June, 2022. Such certification typically involves a type examination (that is, examination of a prototype to confirm that it meets the requirements of the relevant product standard), followed by factory audits/product sampling and testing in order to verify ongoing conformity of the product. The officially recognized accreditation body in Malaysia for conformity assessment activities is the national standards body DSM, which is a signatory to the ILAC MRA for laboratory testing, as well as to the IAF MLA for product and management system certification, among others. 85 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.11 South Africa 3.11.1 Regulatory landscape for COVID-19-related PPE The overarching legislation for health- and safety-related matters in South Africa is the Occupational Health and Safety Act 85 (1993) which, together with its regulations and incorporated standards, requires employers to provide and maintain, as far as is reasonably practicable, a working environment that is safe and without risks to the health of workers. Employers are required to take such steps as may be reasonably practicable to eliminate or mitigate hazards or potential hazards. The act further requires employers to ensure, as far as is reasonably practicable, that all persons who may be directly affected by their activities, such as customers, clients or contractors and their workers who enter their workplace or come into contact with their employees, are not exposed to hazards to their health or safety. In the context of the COVID-19 pandemic, it is important to emphasize that this obligation also applies to self-employed persons, for example, plumbers or electricians, whose working activities bring them into contact with members of the public. With regard to PPE, any product that falls within the definition of a medical device, or that is indicated or intended for use in a medical or health care environment, is regulated as a medical device by the South African Health Products Regulatory Authority (SAHPRA) under the Medicines and Related Substances Act (No. 101 of 1965). SAHPRA was formed in 2018 to replace the existing Medicines Control Council and Directorate of Radiation Control. This includes all the products covered in this guide, with the exception of community face coverings and non-sterile face masks that are not used in a medical or health care environment. Medical devices are classified according to their associated risk to the patient, user, or public health as follows: • A—Low risk • B—Low-moderate risk • C—Moderate-high risk • D—High risk Details of classification criteria and associated standards can be found in the SAHPRA document “Classification of medical devices and IVDs”45 and the 2020 Department of Health document “COVID-19 disease—personal protective equipment, body bags, disinfectants, alcohol-based hand rub, and digital thermometers­—specification guidelines.”46 A medical device may only be manufactured, imported, exported, distributed, or wholesaled by an organization that holds a valid medical device establishment license issued by SAHPRA, in terms of Section 22C(1)(b) of the Medicines and Related Substances Control Act 101 of 1965 after amendment by the Medicines and Related Substances Control Amendment Act (No. 90 of 1997). Some COVID-19-related PPE is also subject to regulation and authorization by the National Regulator for Compulsory Specifications. For example, face masks fall into different regulatory groups depending on the type of mask and its intended use, as shown in Figure 3.5.47 45 https://www.sahpra.org.za/wp-content/uploads/2020/01/Classification_Medical_Devices_IVDs_Nov19_v2.pdf. 46 https://www.nicd.ac.za/wp-content/uploads/2020/11/PPE-Specifications-21-Aug-2020-Signed.pdf. 47 SAHPRA. May 2020 (v2).“Joint SAHPRA/NRCS/SABS Communication to Stakeholders—Regulatory Status of Equipment Being Used to Help ” Prevent Coronavirus (COVID-19). 86 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Figure 3.5: Examples of the classification of masks according to the South African PPE or medical device regulations Non-sterile Non-sterile Respirator mask medical medical Sterile medical (particle filtering Cloth mask (surgical) mask (surgical) mask (surgical) mask Dust mask Respirator mask half mask 1-ply, 2-ply or Examples 3-ply masks 3-ply masks N95, KN95 N95, KN95 3-ply masks Class A med- Non-medical Non-medical Non-medical Class A medi- Non-medical Class B medi- Classification ical device e.g., mining general general cal device general cal device (sterile) industry No SAHPRA Exemption manufacturer, from licensing distributor, No No requirement Yes No Yes No wholesaler for non-sterile license Class A medi- cal devices NRCS sales permit/ No No No No No Yes Yes authorization (LOA) None Yes Yes Yes Yes Specification/ Department of Standards/ Health guide- None SANS 1866-1: SANS 1866-1: None SANS 1866-2: SANS 1866-2: Other line on the 2018 2018 2018 2018 legislation “Use of cloth face masks by Further requirements for employers regarding the use of COVID-19-related PPE are defined in the Disaster Management Act (2020) “Consolidated coronavirus COVID-19 direction on occupational health and safety measures in certain workplaces,” but the Act does not include any specific requirements for PPE itself. 3.11.2 Approach to standardization and key product standards for PPE The South African Bureau of Standards (SABS) is a statutory body that was originally established under the terms of the Standards Act (1945) and currently exists under the Executive Authority of the Minister of Trade, Industry and Competition. The SABS was a founder member of ISO. The legislation concerning the SABS has been modified several times to cater for changing circumstances and to amend the scope of activities of the body. The latest edition is the Standards Act (2008), promulgated “to provide for the development, promotion, and maintenance of standardization and quality in connection with commodities and the rendering of related conformity assessment services.” As the national standardization authority, SABS is responsible for maintaining South Africa’s database of more than 6,500 national standards, as well as developing new standards and revising, amending, or withdrawing existing standards as required. Internationally, SABS experts represent South Africa’s interests in the development of international standards through their engagement with bodies such as the ISO and IEC and, at a regional level, the SADC Cooperation in Standards (SADCSTAN), the standardization body for the Southern African Development Community (SADC) of 14 nations. SABS Commercial (Pty) Ltd. is a self-financing division within the SABS, offering certification, testing, consignment inspection, and other services, mostly to industry. Apart from offering systems certification 87 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets and product testing against the requirements of South African National Standards (SANS), SABS Commercial also operates its proprietary product certification scheme—the SABS Mark of Approval, assuring buyers that products are safe, fit for purpose, and offer redress. Historically, the SABS also undertook certain regulatory functions on behalf of South Africa. However, in keeping with best international practice, this regulatory function was separated from the organization’s standardization and certification activities in 2008 via the promulgation of the new Standards Act (2008) and the National Regulator for Compulsory Specifications Act (2008). Under these new laws, the former SABS Regulatory division separated to form the National Regulator for Compulsory Specifications, also residing under the Department of Trade and Industry. SABS has played a significant role in the development of a standards, quality assurance, accreditation, and metrology infrastructure in the South African Development Community (SADC). It hosts the secretariat of the regional standard coordination forum, SADCSTAN and the legal metrology group, the SADC Cooperation in Legal Metrology (SADCMEL). SABS also operates the National Enquiry Point in support of the WTO/TBT Agreement. Table 3.17 provides an overview of the main product standards for PPE in the South African market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 3.17: Overview of COVID-19-related PPE standards in the South African market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) SANS 50149:2003 Respiratory protective devices—filtering half-masks to protect against particle—requirements, testing, and marking. Identical to EN 149:2001, Respirators since amended 13.1.1 SANS 50143:2003 Respiratory protective devices—particle filters—Requirements, testing, marking. Identical to EN 143:2000, since revised SANS 1866-1:2018 Medical devices. Part 1: Medical face masks. Based on ASTM Medical face F2100, most recently revised in 2021 13.1.2 masks SANS 1866-2:2018 Medical devices. Part 2: Medical respirators based on ASTM F2100 and 42 CFR part 84 Community n/a (under development) 13.1.3 face coverings SANS 50166:2002 Personal eye protection—specifications. Identical to EN 166:2001 Face shields 13.2 SANS 1404:2009 Eye protectors for industrial and non-industrial use Protective SANS 50166:2002 Personal eye protection—specifications. Identical to EN 166:2001 13.2 goggles SANS 1404:2009 Eye protectors for industrial and non-industrial use Medical SANS 11193-1:2010, Single-use medical examination gloves—Part 1: Specification for examination gloves made from rubber latex or rubber solution). Identical to ISO 11193-1: 2008, 13.3.1 gloves since revised SANS 68:2003 Single-use sterile rubber surgical gloves. Identical to ISO Surgical gloves 13.3.2 10282:2002, since revised Suits and n/a 13.4.1 coveralls Aprons n/a 13.4.1 Shoe and head n/a 13.4.1 covers 88 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets SANS 53795:2015 Surgical drapes, gowns, and clean air suits, used as medical devices for patients, clinical staff, and equipment—general requirements Gowns for manufacturers, processors, and products, test methods, performance 13.4.2 requirements, and performance levels. Identical to EN 13795, since replaced by EN 13795-1 and EN 13795-2 3.11.3 Approach to conformity assessment All new requests to place medical devices on the South African market require the following documents to be submitted to SAHPRA to obtain a medical device establishment license: • Cover letter on company letterhead indicating intention to apply for a new SAHPRA license • License application • Proof of payment • Curriculum vitae of the authorized representative • Quality manual • Supportive evidence for each Class C and D PPE listed, including evidence of pre-market approval/ registration/evidence of emergency use authorization for each listed PPE from at least one of the six jurisdictions recognized by SAHPRA (Australia, United States, EU, Brazil, Canada, and Japan) • Certificate of free sale confirming evidence that each listed PPE is legally sold or distributed • Evidence of ISO 13485:2016 certification of the original manufacturer for each listed PPE • Copy of instructions for use for each listed PPE • Copy of labeling and packaging of each listed PPE • Supportive evidence for each Class A (measuring and/or sterile), B, C and/or Class D PPE listed, including evidence of compliance against the minimum requirements and/or certification against relevant standards and specifications as determined by the SABS and/or the National Regulator for Compulsory Specifications. SAHPRA license holders must, as specified in regulation 17 of the regulations relating to medical devices and IVDs and in accordance with the “8.04 Recall, Adverse Event and Post-Marketing Vigilance Reporting of Medical Devices and IVDs”, also: • Report any adverse event or product quality incidents to the authority • Conduct post-marketing vigilance and monitoring of the quality of the PPE. The officially recognized accreditation body for South Africa is the South African National Accreditation System (SANAS). SANAS is responsible for carrying out all accreditations in respect of conformity assessments mandated through the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act (No. 19 of 2006). It is directed and legally represented by a board of directors whose members are appointed by the Minister of Trade and Industry. SANAS is a signatory of the relevant IAF MLA and ILAC MRAs, which include the following scopes in the context of COVID-19: • Management systems (ISO/IEC 17021-1) • Product certification (ISO/IEC 17065) • Calibration (ISO/IEC 17025) • Testing (ISO/IEC 17025) • Medical testing (ISO 15189) • Inspection (ISO/IEC 17020) 89 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.12 United Kingdom 3.12.1 Regulatory landscape for COVID-19-related PPE Since the UK left the European Union, it must be considered as a separate market with its own regulations for PPE and medical devices. UK Conformity Assessed (UKCA) marking indicates conformity with the applicable requirements for products sold within Great Britain. UKCA marking became mandatory following the end of the Brexit transition period although, until an extended deadline of January 1, 2023, for PPE and June 30, 2023, for medical devices, the CE mark is accepted as a valid alternative. Due to its geographical position, Northern Ireland requires manufacturers to follow a distinct UK Northern Ireland (UKNI) marking approval process. Accepted markings or Type of goods combination of markings Manufactured goods being placed on the Great Britain market until the end of 2022 UKCA or CE Placing goods on the market in (June 2023 for medical devices) Great Britain Manufactured goods placed on the Great Britain market from January 1, 2023 (July 1, UKCA 2023, for medical devices) Placing qualifying Northern Qualifying Northern Ireland goods being Ireland goods on the market in placed on the Great Britain market under CE or CE and UKNI Great Britain unfettered access Currently (early 2022) the processes for CE and the UKCA marking are identical, but over time these are expected to diverge as both the EU and UK potentially establish different requirements. The PPE regulation in the UK is now known as the “Regulation 2016/425 on personal protective equipment as brought into UK law and amended” and is enforced by the UK’s Health and Safety Executive. Regarding medical devices, such as surgical gowns and medical gloves for single use, the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) referred to as “UK MDR 2002” apply. These have transposed into UK law, among others, the Directive 93/42/EEC on medical devices (EU Medical Devices Directive), which since May 2021 has been superseded in the EU by the Medical Device Regulation (EU) 2017/745. Under the EU exit transitional arrangements, until June 30, 2023, either the UK MDR 2002 or the EU MDR can be used. After that date, only the UK MDR will be applicable. The regulations on medical devices are enforced by the Medicines and Healthcare Products Regulatory Agency. 3.12.2 Approach to standardization and key product standards for PPE The British Standards Institution (BSI) is a non-profit distributing organization recognized by the UK government as the national standards body. BSI produces British Standards and is also responsible for the adoption of international and European standards in the UK. There are currently several designations for British Standards as they relate to PPE, as follows: • “BS” indicates a standalone British Standard • “BS EN” indicates that the standard is an adoption of the applicable EN standard • “BS EN ISO” indicates that the standard is an adoption of the applicable EN standard, which in turn is an adoption of the applicable ISO standard • “BS ISO” indicates that the standard is a direct adoption of the applicable ISO standard. Following the UK’s exit from the EU, BSI continues its membership of CEN—CENELEC and is therefore still active in the development of and providing inputs into European (EN) standards. The UK now uses the term “designated standards”48 rather than the EU’s “harmonized standards” to bestow presumption of conformity to the UK’s PPE regulation. These standards currently mirror each other, but once again they could diverge over time. 48 https://www.gov.uk/government/publications/designated-standards-ppe. 90 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 3.18 provides an overview of the main product standards for PPE in the UK market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 3.18: Overview of COVID-19-related PPE standards in the UK market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) BS EN 149:2001 +A1:2009 RPD—filtering half-masks to protect against particles— requirements, testing, marking Respirators 14.1.1 BS EN 143:2021 Respiratory protective devices—particle filters— requirements, testing, marking Medical face BS EN 14683:2019 Medical face masks—requirements and test methods 14.1.2 masks Community BSI Flex 5555:2021 Community face coverings—specification 14.1.3 face coverings Face shields BS EN 166:2002 Personal eye protection—specifications  14.2 Protective BS EN 166:2002 Personal eye protection—specifications 14.2 goggles BS EN 455 series (Medical gloves for single use)  BS EN 455-1: 2020 Requirements and testing for freedom from holes BS EN 455-2: 2015 Requirements and testing for physical properties Medical BS EN 455-3: 2015 Requirements and testing for biological evaluation  examination BS EN 455-4: 2009 Requirements and testing for shelf-life determination 14.3.1 gloves BS EN ISO 21420:2020 Protective gloves—general requirements and test methods  BS EN ISO 374-5: 2016 Protective gloves against dangerous chemicals and micro- organisms—requirements for micro-organisms risks BS EN 455 series (Medical gloves for single use)  BS EN 455-1: 2020 Requirements and testing for freedom from holes BS EN 455-2: 2015 Requirements and testing for physical properties BS EN 455-3: 2015 Requirements and testing for biological evaluation Surgical gloves BS EN 455-4: 2009 Requirements and testing for shelf-life determination 14.3.2 BS EN ISO 21420:2020 Protective gloves—general requirements and test methods  BS EN ISO 374-5: 2016 Protective gloves against dangerous chemicals and micro- organisms—requirements for micro-organisms risks BS EN ISO 13688:2013+A1:2021 Protective clothing—general requirements  BS EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents BS EN 13034:2005+A1:2009 Protective clothing against liquid chemicals— Suits and performance requirements for chemical protective clothing offering limited 14.4.1 coveralls protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)  BS EN 14605:2005+A1:2009 Protective clothing against liquid chemicals— performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) 91 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets BS EN ISO 13688:2013+A1:2021 Protective clothing—general requirements  BS EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents BS EN 13034:2005+A1:2009 Protective clothing against liquid chemicals— Aprons performance requirements for chemical protective clothing offering limited 14.4.1 protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)  BS EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals— performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) BS EN ISO 13688:2013+A1:2021 Protective clothing—general requirements  BS EN 14126:2003 Protective clothing—performance requirements and tests methods for protective clothing against infective agents BS EN 13034:2005+A1:2009 Protective clothing against liquid chemicals— Shoe and head Performance requirements for chemical protective clothing offering limited 14.4.1 covers protective performance against liquid chemicals (Type 6 and Type PB [6] equipment) BS EN 14605:2005 +A1:2009 Protective clothing against liquid chemicals— performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) BS EN 13795-1:2019 Surgical clothing and drapes—requirements and test methods— Gowns 14.4.2 Part 1: Surgical drapes and gowns 3.12.3 Approach to conformity assessment The UK is currently following a process similar to that of Europe, meaning that all PPE and medical devices must comply with the associated regulation, but with the use of the UKCA mark instead of the CE marking. The UKCA marking on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant UK legislation and the product may be sold in the United Kingdom. It is a criminal offence to affix UKCA marking to a product that is not compliant or to offer it for sale. Both the PPE Regulation (EU 2016/425) and the MDR (EU 2017/745) are based on the existing European “New Approach Directives.” This means that manufacturers, or their authorized representative in the UK, must demonstrate compliance with the essential health and safety requirements of the applicable regulation either directly or by demonstrating conformity to the associated designated standards (presumption of conformity to the regulation). Because the regulations are often very generic and performance-based in their requirements (which in some cases can apply to broad families of products), demonstration of conformity to the designated standards is often the preferred way of demonstrating conformity to the regulation. Depending on the risk classification, certain categories of PPE and medical devices are subject to conformity assessment by an “approved body”. The approved body status is bestowed by the relevant UK government department—the Department for Business, Energy & Industrial Strategy in the case of PPE, and the Medicines and Healthcare Products Regulatory Agency for medical devices. Full details of approved bodies can be found on the UK government’s website.49 Medical devices under the scope of this guide are Class I. The intervention of an approved body is only necessary for sterile products and only in relation to sterilization process. The officially recognized accreditation body in the UK for conformity assessment activities is the United Kingdom Accreditation Service (UKAS) which is a signatory to the ILAC MRA for laboratory testing, as well as to the IAF MLA for product and management system certification, among others. 49 https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices. 92 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.13 Vietnam 3.13.1 Regulatory landscape for COVID-19-related PPE The first Occupational Safety and Health (OSH) Law was passed by the National Assembly of Vietnam in June 2015. The Ministry of Health is in charge of managing the OSH Law for activities, equipment and chemicals used in the medical/pharmacy sector. Article 23 of the OSH Law requires that, when providing PPE, employers must ensure that the correct types of PPE are available with the quality as prescribed by national technical standards and regulations. The government’s response to COVID-19 was spearheaded by the multi-sectoral National Steering Committee for the Prevention and Control of COVID-19, chaired by the Vice Prime Minister and comprising members from 23 ministries. This structure was replicated throughout provincial and local levels and all public and private organizations. The following technical regulations were issued in the early stages of the pandemic: Decision 870/QD-BYT dated March 12, 2020: Temporary technical guidance for splash-resistant and antibacterial fabric masks. This decision addresses technical specifications for washable (reusable) cloth masks which have a bactericide material (nano silver, activated carbon, or equivalent). It encompasses requirements and test methods from standards TCVN 8389-1:2010 and TCVN 8389-2:2010 on medical face masks. Decision 1444/QD-BYT dated March 29, 2020: Temporary guidance on the selection and use of masks in prevention and control of COVID-19 epidemic. This decision specifies three types of face masks offering different protection levels (from highest to lowest): • FFP2, according to the EU classification (or US N95) • Masks complying with Vietnamese standards TCVN 8389-1 to -3 • “870 masks” complying with the decision above It also recommends mask types for use in specific situations (that is, hospital rooms with confirmed COVID-19 cases, screening areas, and so on). Decision 1616/QD-BYT dated April 8, 2020: Temporary guidance on techniques, classification, and selection of COVID-19 pandemic prevention clothing. The objectives of this decision are to provide: • Guidance on technical standards for COVID-19 prevention clothing • Guidance on classification of suits to prevent the spread of COVID-19 • Instructions for choosing the appropriate protective clothing in professional work. This document is based on the US standard ANSI/AAMI PB 70:2012 describing liquid barrier performance levels (1-4; 1 being the lowest) and classification of surgical and isolation gowns for use in health care settings. With respect to medical devices, registration and monitoring is performed by the Department of Medical Equipment and Construction (DMEC), under the Ministry of Health. The basic regulation consists of Decree No. 36/2016/ND-CP, which has been subsequently modified by Decrees No. 169/2018/ND-CP and No. 03/2020/ND-CP. Medical devices are split into two groups which are classified into four categories based on the level of potential risks related to their technical design and manufacture: Group 1 includes Class A (low risk) while Group 2 includes Categories B (medium to low risk), C (medium to high risk) and D (high risk). The classification rules are compliant with international treaties on classification of medical devices of the Association of Southeast Asian Nations (ASEAN) of which Vietnam is a member. The classification must be made by qualified entities in Vietnam (previously, classification by foreign entities was accepted). 93 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.13.2 Approach to standardization and key product standards for PPE The national standardization body of Vietnam is the Directorate for Standards, Metrology and Quality (STAMEQ) (https://tcvn.gov.vn/?lang=en), a governmental body under the Ministry of Science and Technology. It has the responsibility of advising the government on issues in the fields of standardization, metrology, productivity, and quality management in the country and it represents Vietnam in the ISO, IEC and regional standardization organizations. The function, duties, and organizational structure of STAMEQ are stipulated in the Prime Ministerial Decision 27/2014/QD-TTg. The overall approach to standards in Vietnam is as follows (in line with the findings of a recent United Nations Development Programme Vietnam study on PPE carried out in 2020–21):50 • There are some Vietnamese standards (TCVN) for PPE related to medical/health care applications, but they do not cover all products (that is, medical gowns, respiratory protection equipment) • In most instances, these are adaptations of ISO standards but are not always aligned with the latest versions • A review is currently underway on the range of available standards and to promote their alignment with international best practices. Table 3.19 provides an overview of the main product standards for PPE in the Vietnamese market and an indication about whether these are based on or are similar to versions of other national, regional, or international standards. Users are advised to use caution with these comparisons and to consult the more detailed information in other parts of the guide by following the links provided. Table 3.19: Overview of COVID-19-related PPE standards in the Vietnamese market Color coding: Green: Based on or similar to ISO standard Yellow: Based on or similar to EN standard Blue: Based on or similar to a US standard Red: Standalone national standard Blank: No applicable national standard More PPE Main product standards details (link) Respirators  n/a 15.1.1 TCVN 8389-1: 2010 Medical face mask—Part 1: Normal medical face mask Medical face TCVN 8389-2:2010 Medical face mask—Part 2: Medical face mask preventing 15.1.2 masks bacteria Community n/a 15.1.3 face coverings Face shields n/a 15.2 Protective  n/a 15.2 goggles TCVN 6343-1:2007 Single-use medical examination gloves—Part 1: Specification for gloves made from rubber latex or rubber solution). Identical to ISO 11193-1: 2002 with AMD 1: 2007 (since revised)  Medical TCVN 6343-2:2007 Single-use medical examination gloves. Part 2: Specification for examination 15.3.1 gloves made from poly(vinyl chloride) Identical to ISO 11193-2:2006 (current) gloves TCVN 12326-5:2018 Protective gloves against dangerous chemicals and micro- organisms—Part 5: Terminology and performance requirements for micro- organisms risks. Identical to ISO 374-5:2016 (current) 50 https://www.undp.org/vietnaml. 94 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets TCVN 6344:2007 Single-use sterile rubber surgical gloves. Identical to ISO Surgical gloves 15.3.2 10282:2002 (since revised) Suits and TCVN 6689:2021 Protective clothing—general requirements. Identical to ISO 15.4.1 coveralls 13688:2013 + AMD1:2021 TCVN 6689:2021 Protective clothing—general requirements. Aprons 15.4.1 Identical to ISO 13688:2013 + AMD1:2021 Shoe and head TCVN 6689:2021 Protective clothing—general requirements. 15.4.1 covers Identical to ISO 13688:2013 + AMD1:2021 Gowns n/a Regarding PPE for the COVID-19 pandemic, temporary guidance has also been provided in the Decision 1616/QD-BYT dated April 8, 2020, which directly defines the essential requirements and/or standards to be applied. This is a temporary guidance, subject to updates. Table 3.20 provides a summary. Table 3.20: Essential requirements defined directly in Decision 1616/QD-BYT dated 08/04/2020 PPE type Requirements Comments If PPE is to be sterilized, bioburden All per EN ISO 11737-1 ≤30 CFU/g EU: type FFP2 NR (respirators) Comply with EU: type I, II or IIR (medical masks) EN 149:2001 + A1: 2009 or “High-filtration efficiency masks” US: type N95 (respirator) EN 14683:2019 or Equivalent types complying with 42 CFR part 84 standards from other countries are also accepted Comply with TCVN 8389-1:2010 or Standard medical masks or medical Medical masks masks to prevent infection TCVN 8389-2:2010 Anti-droplet and antibacterial According to Decision 870/QD-BYT cloth masks Face shields Listed in Decision 1616/QD-BYT Comply with TCVN 5039:1990, EN 166:2002 Safety goggles ANSI Z87.1:2015 Made from rubber Disposable medical examination gloves Comply with TCVN 6343-1:2007 or or PVC. 6343-2:2007 Decision does not include requirements for surgical gloves In the decision, EN 13795-1 is mentioned but no explicit Medical gowns — requirements for medical gowns are defined Classified as level 1-4 per ANSI/AAMI PB 70 In the US, the testing standard ASTM F1671 is used for level 4. This is very Protective clothing or similar to the international standard ISO 16604 used in the EU Class 1 to 6 per EN 14126, clause 4.1.4.1 95 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 3.13.3 Approach to conformity assessment Simplified approval procedures (“quick registration”) apply for products already circulating in at least two countries from within the EU member states, Japan, Canada, Australia, and the United States. A proposed revision will add the UK and Switzerland to the list and reduce the need for circulation to only one country. The ASEAN Common Submission Technical Dossier (CSTD) has been applied from January 1, 2022. Manufacturers of medical devices, which includes most the aforementioned PPE, have been required to apply a quality management system per TCVN ISO 13485:2017 since January 1, 2020. Conformity assessment bodies must register and fulfil the relevant requirements for the appropriate areas of activity according to Decree 107/2016/ND-CP. They must be accredited by an accreditation body signatory to the IAF MLA for certification bodies or the corresponding ILAC MRA for inspection bodies or laboratories. In Vietnam, there are two such accreditation bodies, the Bureau of Accreditation (http://www.boa. gov.vn/en) and the Accreditation Office for Standards Conformity Assessment Capacity. The Bureau of Accreditation is a signatory of the relevant ILAC MRA for laboratory testing as well as the IAF MLA for product and management system certification, while the Accreditation Office is a member of the ILAC MRA for laboratories (https://www.aosc.vn/). 96 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 4 PRODUCT-SPECIFIC COMPARISONS OF EU AND US MARKETS 4.1 Masks This section is divided into sub-sections corresponding to the three main categories of masks (see product overview in section 2.1): • Respirators (also known as respiratory protective equipment, respiratory protective devices [RPD], or filtering face piece respirators) • Medical face masks • Community face coverings 4.1.1 Respirators 4.1.1.1 EU market requirements Respirators are covered by the EU PPE Regulation (EU) 2016/425, which superseded the PPE Directive 89/686/ EEC. The regulation is based on the “new approach” aligned to the “new legislative framework” policy, under which manufacturers, or their authorized representatives in the EU, must demonstrate compliance with the essential health and safety requirements of the PPE Regulation, directly or by using harmonized European standards. The latter confers presumption of conformity to the regulatory requirements. The harmonized standard in the case of respirators is EN 14951 and they are Category III PPE according to the regulation. Note: A transition process has been outlined in Article 47 of the PPE Regulation which states “without prejudice, member states shall not impede the making available on the market of products covered by Directive 89/686/EEC which are in conformity with that directive and which were placed on the market before 21 April 2019 and also EC type-examination certificates and approval decisions issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date.” Particle-filtering half-masks are classified according to their penetration of filter material and their maximum total inward leakage. Penetration of filter material is tested per EN 13274-7, using both sodium chloride (NaCl) and paraffin oil aerosols. “Filtering efficiency”, defined as 100 percent minus “penetration of filter material”, is a commonly used term. There are three classes of devices: FFP1, FFP2, and FFP3 with filtering efficiencies of minimum 80 percent, 94 percent, and 99 percent respectively (FFP1 is not recommended by WHO). The total inward leakage is tested using a panel of 10 human subjects and only NaCl aerosol. The limits are expressed as percentage leakage (both as individual values and arithmetic means) and they are stricter the higher the respirator class is. Other important characteristics include: • Breathing resistance, measured both for inhalation (less strict limits, that is, more difficulty in breathing, for increasing filtering efficiency) and exhalation (same limits for all respirator classes) 51 EN 149:2001+A1:2009.“Respiratory protective devices— filtering half-masks to protect against particles—requirements, testing, marking. ” 97 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets • Carbon dioxide (CO2) content in the “dead space” of the respirator (average ≤1 percent for all classes) • Practical performance, tested by two subjects carrying out specified tasks. In addition to their filtering efficiency class, respirators: • Can be single-shift, that is, non-reusable (marked NR)—or reusable (marked R), though the latter is not recommended for a medical environment • Can exhibit clogging resistance (marked D)—not required in a medical environment • Can have an exhalation valve—not indicated in a medical environment. 4.1.1.2 US market requirements Respirators typically used in US health care and related functions include: • Filtering face piece respirators (disposable) • Elastomeric half face piece air-purifying respirators, or APR (reusable face piece, disposable filters) • Powered air-purifying respirators, or PAPR (reusable blower, other reusable components, disposable filters) Respirators are PPE subject to the National Institute for Occupational Safety and Health (NIOSH) 42 CFR Part 84 (Approval of Respiratory Protective Devices)—available for free download from the US Code of Federal Regulations, at https://ecfr.federalregister.gov/. This includes the following main topics: • 84.170 Air-purifying particulate respirators; description • 84.171 Required components and attributes • 84.172 Airflow resistance test • 84.173 Exhalation valve leakage test • 84.174 Filter efficiency level determination test—non-powered series N, R, and P filtration Subpart K of 42 CFR Part 84 specifies the requirements for “air-purifying particulate respirators” as follows: • Non-powered air-purifying particulate respirators (series N, R, and P). These utilize the wearer’s negative inhalation pressure to draw the ambient air through the air-purifying filter elements (filters) to remove particulates from the ambient air. They are designed for respiratory protection against atmospheres with particulate contaminants at concentrations that are not immediately dangerous to life or health and that contain adequate oxygen to support life • N-series filters are restricted for use in workplaces free of oil aerosols (which is the case for COVID-19 applications) and are further subdivided according to the efficiency level of the filter(s) as follows: 1. N100 filters, min. 99.97 percent efficiency 2. N99 filters, min. 99 percent 3. N95 filters, min. 95 percent Other relevant subparts of CFR Part 84 include: • Subpart A—General provisions • Subpart B—Application for approval • Subpart C—Fees • Subpart D—Approval and disapproval • Subpart E—Quality control 98 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets In addition to specifying requirements and conformity assessment criteria, 42 CFR Part 84 also specifies the testing methods to be used. These are based on the NIOSH procedures as follows: Characteristic NIOSH procedure for test method52 Filtration efficiency TEB-APR-STP-0059 (for N95) Airflow resistance for inhalation TEB-APR-STP-0007 Airflow resistance for exhalation TEB-APR-STP-0003 Exhalation valve leakage TEB-APR-STP-0004 There are no requirements for measuring the build-up of carbon dioxide in the respirator or the amount of total inward leakage. The latter property is addressed in separate Occupational and Safety Health Administration (OSHA) regulations, covered in 29 CFR Part 1910.134, where employees must be subject to quantitative fit testing and achieve a fit factor of at least 100 for the specific respirator. The approval process for respirators is shown in Figure 4.1. Figure 4.1: NIOSH process for approval of respirators in the US market53 Source: Jeffrey O. Stull, International Personnel Protection, Inc. 4.1.1.3 Comparison between EU, US, and ISO criteria A summary of the main differences between EN 149 and 42 CFR Part 84 Subpart K is as follows. Further details can be found in Table 4.1. • There is an approximate equivalence as follows: 52 For details related to N95 respirators and other filtering face piece respirators used in health care, see the CDC website at https://www.cdc.gov/ niosh/npptl/resources/certpgmspt/pdfs/APR-FFR-03122018-508.pdf. 53 For further details, see the CDC website at https://www.cdc.gov/niosh/npptl/respmanuf.html. 99 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets • FFP2  N 95 • FFP3  N 99 • Filter efficiency is calculated differently • Testing for the United States is restricted to the National Personal Protective Technology Laboratory • Breathing resistance flow and pressure limits differ because of the different flow rates specified by the various standards for the inhalation and exhalation resistance tests. Although this appears to suggest that the standards’ requirements for breathing resistance differ from each other, it is important to understand that pressure drop across any filter will naturally be higher at higher flow rates. Given typical pressure curves for respirator filters, the standards’ various pressure drop requirements are actually quite similar54 • In the United States, carbon dioxide content of inhalation air and total inward leakage are not specified. It is also noted that ISO technical committee TC 45/SC 15 is in the process of developing a comprehensive range of RPD standards covering the following areas: • ISO 16900 series: Methods of test and test equipment (14 parts) • ISO 16972: Vocabulary and graphical symbols • ISO 16973: Classification • ISO 16975 series­ : Selection, use and maintenance (four parts, among them—under development—Part 4: Selection and usage guideline for RPD under pandemic/epidemic/outbreak of infectious respiratory disease) • ISO 16976 series: Human factors (eight parts) • ISO 17420 series: Performance requirements for various types of respiratory products (nine parts; most relevant to the scope of this guide are Part 1: General and Part 2: Requirements for filtering RPD, both published in 2021). Due to the difference in approaches between EN and ISO standards (product versus wearer-related requirements) and the strong interplay between RPD standards and the PPE Regulation in the EU, the above standards are not envisioned to be adopted as EN ISO in the foreseeable future. The only ISO standard adopted by the relevant standardization committee in Europe (CEN TC 79) is ISO 16972. 54 3M. 2020.“Comparison of P2, FFP2, KN95, and N95 and Other Filtering Facepiece Respirator Classes. ” Technical bulletin. https://multimedia.3m. com/mws/media/1793275O/3m-anz-2020-comparison-of-ffp2-kn95-and-n95-and-other-filtering-facepiece-respirator-classes.pdf. 100 Table 4.1: Comparison of standards for respirators in the EU and US markets and applicable ISO testing standards Color code for EU/US comparisons: Green: Same requirement and same (or similar) test methods Yellow: Similar requirement but with different test methods Red: Requirements are more stringent Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. EU (Market) US EN 149:2001+A1:2009, Classes FFP2 and ISO standard 42 CFR Part 84, Series/Levels N95 and N99 FFP3 COMPARISON/COMMENTS Characteristic/ Testing method Requirement Requirement Testing method Testing method Technical regulations and standards for PPE in select markets property Fit testing before use (required by OSHA, not NIOSH) ASTM F3387-19 “A qualitative ISO 16975-3:2017 or quantitative respirator Respiratory protective Practical devices—selection, use Pass Pass fit test shall be used to performance and maintenance— determine the ability of the Part 3: Fit-testing individual respirator wearer procedures to obtain a satisfactory fit with a tight-fitting TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT respirator” FFP2 ≤ 11% leakage (individual values) N95 n/a Not required in the US ≤ 8% leakage ISO 16900-1:2019 (arithmetic Respiratory protective mean) devices—methods Total inward FFP3 ≤ 5% of test and test leakage leakage equipment—Part 1: (individual Determination of values) N99 n/a As above inward leakage ≤ 2% leakage (arithmetic mean) 101 EU 102 (Market) US EN 149:2001+A1:2009, Classes FFP2 and ISO standard 42 CFR Part 84, Series/Levels N95 and N99 FFP3 COMPARISON/COMMENTS Characteristic/ Testing method Requirement Requirement Testing method Testing method property ISO 16900-3:2012 EN 13274-7. Mechanical FFP2 ≥ 94% (@ Respiratory protective strength conditioning 95 L/min)­— TEB-APR-STP-0059 (NIOSH) In the EU, testing with both devices—methods per EN 143. Particle specified as max NaCl and paraffin oil aerosols is of test and test size distribution N95 ≥ 95% penetration of required, while in the US only equipment—Part measurement Filtering 6% testing with NaCl is required 3: Determination according to ISO efficiency of particle filter 15900:2020 penetration FFP3 ≥ 99% (@ 95 L/min)­— N99 ≥ 99% Technical regulations and standards for PPE in select markets specified as max penetration of 1% Compatibility Pass n/a Not required in the US with skin Flammability Burner to ISO 6941 Pass n/a Not required in the US Average ≤ 1% by Carbon dioxide volume in “dead n/a Not required in the US content space” (OSHA requirement, not Field of vision Pass Pass NIOSH) ISO 16900-2:2017 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Respiratory protective FFP2 ≤ 70 Pa (@ N95 ≤ 343 Pa devices—methods 30 L/min) (@ 85 L/min)— of test and test ≤ 240 Pa (@ 95 L/ specified as 35 Breathing mm H2O equipment—Part 2: min) (NIOSH) TEB-APR-STP-0007 resistance Determination of (inhalation) (inhalation) breathing resistance N99 ≤ 343 Pa FFP3 ≤ 100 Pa (@ 85 L/min)— (@ 30 L/min) specified as 35 ≤ 300 Pa (@ 95 mm H2O L/min) Breathing FFP2 and FFP3 N95 and N99 (NIOSH) TEB-APR-STP-0003 ≤ 245 Pa (@ 85 L/ (exhalation) resistance ≤ 300 Pa (@160 L/ min)—specified (exhalation) min) as 25 mm H O 2 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 4.1.2 Medical face masks 4.1.2.1 EU market requirements These are considered as Class I medical devices according to the European Union Medical Device Regulation (EU) 2017/745 (EU MDR). The performance/testing standard is EN 14683:2019,55 “Medical face masks—requirements and test methods.” The standard defines three types of masks: I, II, and IIR. They differ on two important characteristics regarding infective agents: • Type I has bacterial filtration efficiency (BFE) of min. 95 percent • Types II and IIR have a BFE of min. 98 percent • Type IIR is the only “splash-resistant” type; it can withstand spurts of synthetic blood under conditions and methods specified in ISO 22609. Another important characteristic is breathability (same limit for Types I and II, higher for Type IIR, that is, worse breathability, justified by its increased resistance to penetration). Other characteristics are bioburden (same limits for all types) and biocompatibility (passes evaluation per EN ISO 10993-1). As it is stated in the standard, “Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by health care professionals in an operating room or in other medical settings with similar requirements.” Conformity assessment: • As a Class I medical device, for products not delivered sterile: assemble technical documentation, issue EU declaration of conformity and operate a quality management system to ISO 13485 for production as well as a post-market surveillance system for any adverse effects • For terminally sterilized packages, in addition to the above, involvement of a notified body is needed to evaluate the quality assurance of the sterilization process. 4.1.2.2 US market requirements The main technical standard is ASTM F2100-21, “Standard specification for performance of materials used in medical face masks,” which covers both surgical masks (with head ties) and isolation masks (sometimes called procedure masks) having ear loops (see also section 2.1.2). The ASTM standard defines three barrier levels: Level 1, having BFE of min. 95 percent, while Levels 2 and 3 have min. 98 percent. Unlike, however, in the EN standard, all three barrier levels exhibit: • Splash resistance (higher as the level increases) • Sub-micron particulate filtration efficiency (not required in EN 14683) • Flammability characteristics (measured according to 16 CFR Part 1610). As with the corresponding EN, breathability of the mask is specified (same increased limit for Levels 2 and 3 compared to Level 1, that is, worse breathability due to the higher filtering efficiency and splash resistance). Surgical masks are Class II medical devices, subject to the US Food and Drug Administration (FDA) Regulations, Part 878­ —Surgical Devices; 21 CFR 878.4040 —General and Plastic Surgery Devices, Subpart E­ (see also section 3.2.3). 55 Note: This is recognized as a“harmonized standard” in the EU, with a presumption of conformity to the essential requirements of the previous Directive 93/42/EEC (but, as of 31 December, 2021, not yet for [EU] 2017/745). 103 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 4.1.2.3 Comparison between EU and US criteria The main similarities/differences regarding the test methods are: • BFE—the method referenced in ASTM F2100 is ASTM F2101 which is very similar to the methodology of EN 14683 (Annex B) • Differential pressure—both ASTM F2100 and EN 14683 refer to Annex C of EN 14683 • Particle filtration efficiency according to ASTM F2299 is not required by EN 14683. ASTM F2299 uses aerosols with latex spheres for materials (unlike EN 149/EN 13274-7 which use NaCl or paraffin oil aerosols on final products) • ASTM F2100 requires the resistance to penetration by synthetic blood to be measured according to ASTM F1862 (very similar to ISO 22609:2014) • ASTM F2100 requires flammability testing according to 16 CFR Part 1610 • Biocompatibility requirements which were not explicitly addressed in ASTM F2100-20 are now included in the current edition (ASTM F2100-21), similar to the EN standard. A comparison of the key requirements is provided in Table 4.2. Table 4.2: Comparison between EU and US standards for medical face masks Color code for EU/US comparisons: Green: Same requirement and same (or similar) test methods Yellow: Similar requirement but with different test methods Red: Requirements are more stringent Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. EU US (Market) EN 14683:2019, ASTM F2100-21, COMPARISON/COMMENTS standard Types I, II, and IIR Levels 1, 2, and 3 Characteristic/ Testing Testing Requirement Requirement property method method ≥95% (Type I) ≥95% (Level 1) Limits essentially same (for Bacterial filtration ASTM ≥98% (Type II, ≥98% (Level corresponding types); testing efficiency (BFE) F2101 IIR) 2, 3) methods essentially same ≥95% at 0.1 micron (Level Particulate 1) filtration n/a n/a Only a US requirement efficiency (PFE) ≥98% at 0.1 micron (Level 2, 3) <49 Pa/cm2 (Level 1)­— specified as <40 Pa/cm2 < 5 mm H2O/ Limits for Types I, II are 20% (Type I, II) cm2 lower than for Level 1 (better Pressure drop EN 14683 breathability in the EU); limits for <60 Pa/cm2 <58.8 Pa/cm2) Type IIR about same as for Levels (Type IIR) (Level 2 & 3)— 2,3; identical testing methods specified as < 6 mm H2O/ cm2 104 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets ≥ 10.67 kPa (Level 1)— specified as ≥ 80 mm Hg Limit same for Type IIR and Level ≥ 16 kPa (Level 2; limits not set for Types I, II. For Synthetic blood ISO ≥16 kPa (Type 2)— specified ASTM Level 1 (3) lower (higher) limits penetration 22609:2004 IIR only) as ≥ 120 mm F1862 Hg than Level 2; essentially same methods in EU/US ≥ 21.33 kPa) (Level 3)— specified as ≥ 160 mm Hg Microbial EN ISO ≤30 (CFU/g) n/a Only an EU requirement cleanliness 11737-1:2018 Masks are considered in the EU ISO as surface devices in contact with EN ISO Passes Passes Biocompatibility 10993 intact skin with limited exposure, 10993 series evaluation evaluation series while in the US with long-term exposure Class 1 according to Flammability n/a Only a US requirement 16 CFR Part 1610. 4.1.3 Community face coverings 4.1.3.1 EU market requirements Community face coverings are not subject to any specific EU regulations, but nevertheless are covered by Directive 2001/95/EC on general product safety. Under this directive, a product is considered safe if it meets all statutory safety requirements under European or national law. As of December 2021, there is no European standard for community face coverings, although criteria have been defined in the CEN Workshop Agreement (CWA) 17553:2020 (“Community face coverings— guide to minimum requirements, methods of testing, and use”). CWA 17553 prescribes requirements for reusable or disposable community face coverings intended for the general public, including the following: • The mask must cover the nose, mouth, and chin, with no valves, made of one or multiple fabric layers (woven, knitted, non-woven, and so on) with or without film. It can have an attachment for either the head or ears • Must be able to withstand handling and wear throughout the indicated lifetime; need to consider breathability, moisture absorption, and biocompatibility • Filtration efficiency of the material: two levels according to filtration efficiency to particles around 3 (± 0.5) μm: • ≥ 90% • ≥ 70% Filtration efficiency can be either for particles (PFE—by one of three options) or bacterial (BFE—by EN 14683) • Three options for demonstrating breathing resistance and air permeability (EN 14683; EN 13274-3; EN ISO 9237) • Differential pressure of the material ≤ 70 Pa/cm2 105 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets • Inhalation resistance ≤ 2.4 mbar and exhalation resistance ≤ 3 mbar • Air permeability ≥ 96 l/s/m2 for a vacuum pressure of 100 Pa • Reusable masks must be capable of withstanding at least five cleaning cycles with minimum washing temperature of 60°C according to EN ISO 6330 or producer instructions • Recommended to use recyclable or compostable material to reduce the environmental impact. In the relevant European Standardization Committee (CEN TC 248 “textiles and textile products”), a technical specification is under development (as of December 2021), to be published as CEN/TS 17553: “Textiles and textile products—community face coverings—minimum requirements, methods of testing and use.” This deals with the following aspects of textiles, textile products, and textile components of products: • Test methods (including relevant testing equipment) • Terms and definitions • Specifications and, if necessary, classifications in terms of their expected behavior. It will also address the use of multi material textile-based face coverings, and textile-based face coverings incorporating transparent elements to allow for lip reading. 4.1.3.2 US market requirements Requirements for community face coverings are currently provided in ASTM F3502-21 “Standard specification for barrier face coverings.”56 The objective of a face covering to ASTM F3502 is twofold: • Source control (to protect the public) • Offer protective capability (protect the wearer). The standard includes the following requirements: • Design: Minimum criteria are specified that entail fully covering the mouth and nose of the wearer; the use of non-toxic, non-irritating materials, providing a means of retention on the head; the availability of sizes • Protection: • Measurement of sub-micron particulate filtration efficiency and airflow resistance (based on 42 CFR Part 84 Subpart K) applied to single-use and reusable products (reusable products are evaluated before and after maximum number of laundering or cleaning cycles specified by manufacturer). The use of a fixture for supporting samples is also permitted if the product does not seal directly onto the test stand. • Seals to the face and to prevent particles going around the perimeter of the mask. Manufacturer has to report a product design analysis self-declaration; optional to use a modified version of ASTM Test Method F3407 (“Standard test method for respirator fit capability for negative-pressure half-face piece particulate respirators”) • Comfort: The face coverings must be comfortable enough for people to wear for long periods of time • The potential that products could be used over again. Two levels of filtration and breathability performance are defined in the standard, as follows: 56 Prior to the publication of ASTM F3502, guidance was available from the American Association of Textile Chemists and Colorists’ standard AATCC M14 (“Guidance and considerations for general purpose textile face coverings”). Although this was referenced in the Interim WHO guidance (December 2020), for the purposes of this benchmarking guide only the ASTM specification is considered. 106 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Property Level 1 (lower performance) Level 2 (higher performance) Filtration efficiency ≥20% ≥50% Airflow resistance ≤15 mm H2O ≤5 mm H2O (breathability) Each performance property is classified separately, which is why there are four possible sets of classifications for a community face covering. Conformity assessment of the product is based on a supplier’s declaration of conformity with a requirement for testing laboratories to be accredited to ISO/IEC 17025 for the specific tests. 4.1.3.3 Comparison between EU and US criteria CWA 17553 and ASTM F3502 are written in different styles and format, making direct comparison difficult. ASTM F3502 uses whole-product filtration and air-resistance tests compared to CWA 17553. A summary of some key characteristics is nevertheless provided in Table 4.3, but users are encouraged to consult the actual standards for definitive criteria. Table 4.3: Comparison between EU and US standards for community face coverings Color code for EU/US comparisons: Green: Same requirement and same (or similar) test methods Yellow: Similar requirement but with different test methods Red: Requirements are more stringent Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. (Market) standard EU US COMPARISON/ CWA 17553:2020 ASTM F3502-21 COMMENTS Characteristic/ Testing Requirement Requirement Testing method property method Breathing resistance EN ≤ 70 Pa/cm2 Level 1 ≤ 15 mm Subpart K of 1. Alternate 14683:2019, or H2O 42 CFR Part 84, characteristic Annex C or modified as per to breathing Inhalation Level 2 ≤ 5 mm § 8.2 resistance in EN 13274-3 resistance H2O the EU is air of 2.4 mbar permeability, see Exhalation below resistance 3 mbar 2. In the US the breathing resistance of the entire mask is measured (not per unit area) Air permeability EN ISO 9237 ≥ 96 l/s/m2 @ n/a 100 Pa Particle filtration EN 13274-7 or Level 90% ≥ Level 1 ≥20% Subpart K of Alternate efficiency (PFE) EN ISO 16890- 90% Level 2 ≥ 50% 42 CFR Part 84, characteristic 2 or Level 70% ≥ 70% modified as per to PFE in the EU EN ISO 21083- Particle size 3 (± Sub-micron § 8.1 is BFE test (see 1:2018 0.5) μm particle size below) 107 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Bacterial filtration EN Level 90% ≥ Manufacturer efficiency (BFE) 14683:2019, 90% may choose to Annex B provide the BFE Level 70% ≥ 70% results (as per ASTM F 2101) along with PFE Inward leakage n/a Results to be Determined reported (no through a criteria are set) design analysis or optional application of a modified form of ASTM F3407 (quantitative leakage testing) 4.2 Eye and face protection This section covers the requirements for both glasses/goggles and face protection, all of which are covered by standards with similar scopes in both markets. A useful reference is ISO 4007:2018 “Personal protective equipment—eye and face protection—vocabulary,” which can be browsed freely on the ISO website. 4.2.1 EU market and ISO requirements In the EU, the standard EN 166:2001, “Personal eye protections—specifications,” covers all safety eyewear (including spectacles, goggles, and face shields). The EN 166 standard includes requirements for lenses (which are called “oculars” in the standard and can be prescription or not, mounted or unmounted) and complete eye protectors and frames. The standard is a generic one covering several fields of use. For the purposes of this guide, only the fields of “basic use” and “droplets and splashes of liquids” are considered. The requirements of the standard are split into the categories: • Basic (applicable for all eye protectors) • Particular (depending on the field of use) • Optional requirements Among those, a selection of the categories most relevant to medical PPE is made in this guide. Lastly, the standard makes reference to the following testing method standards: • EN 167 (for optical test methods) • EN 168 (for non-optical test methods) EN 166 is likely to be replaced by the recently published ISO 16321-1:2021 standard, “Eye and face protection for occupational use—Part 1: General requirements,” which additionally covers face protection. It has already been adopted as a European standard but has not yet become a harmonized standard (see 3.1.2). ISO 16321-1 supersedes ISO 4849:1981, ISO 4851:1979, ISO 4852:1978, and ISO 4856:1982. Requirements in the ISO 16321-1 standard are split into: • General • Geometrical optical (testing methods in ISO 18526-1) • Physical optical (testing methods in ISO 18526-2) • Physical and mechanical (testing methods in ISO 18526-3) They are also separated as mandatory and optional requirements (depending on the intended use, some optional may become mandatory). 108 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets ISO 16321-1 uses test methods from the ISO 18526 series of standards (four parts, as above, plus ISO 18526- 4 about head forms used in testing). ISO 18526-1 and -2 cancel and replace ISO 4854:1981 while ISO 18526- 3 supersedes and replaces ISO 4855:1981. The ISO 18526 series of standards is also expected to replace the relevant testing method standards EN 167 and EN 168. In the EU, PPE for either eye or face protection will fall under the PPE Regulation and be classified as Category II products (see PPE Regulation guidelines mentioned in 3.1.2). 4.2.2 US market requirements ANSI/ISEA Z87.1:2020: The “American national standard for occupational and educational personal eye and face protection devices” is also a generic standard, covering all types of eye and face protection in the United States. Requirements in the standard are split into: • Fundamental design requirements for all protectors (includes optical and physical requirements) • Optional design requirements (includes anti-fog properties) • Optional hazard-specific requirements (includes droplet and splash-protector requirements). Test methods are included in Chapter 9 of the standard. In July 2021, another standard was published: ANSI/ISEA Z87.62-2021, “American national standard for occupational and educational personal eye and face protection devices for preventing exposures caused by sprays or spurts of blood or body fluids.” This standard addresses protection from the risk posed by the presence of spray and spurt of biological hazards. However, it does not yet address the risk from aerosolized pathogens, which may be considered in future editions. In the Z87.62 standard, three product protection categories are defined: C1 (for eyes only), C2 (for nose and mouth only), and C3 (for all three). A main requirement of this standard is the experimental validation of the effective coverage area (for the protection categories claimed) by employing a spray and spurt test using a biofluid simulant. It should be noted that the test measures the exposure to the physical hazard (blood or other body fluid) and not the transmission of pathogens that it may carry. In the United States, eye and face protection equipment used in health care settings are both considered as Class I medical devices, and therefore, are exempt from FDA 510(k) submissions (see 3.2.3). 4.2.3 Comparison between EU, US, and ISO criteria A comparison of relevant characteristics between the EU, the United States, and ISO can be seen in Table 4.4. 109 Table 4.4: Comparison between EU, US, and ISO standards for eye and face protection 110 Color code for EU/US comparisons: Green: Same requirement and same (or similar) test methods Yellow: Similar requirement but with different test methods Red: Requirements are more stringent Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Notes: • For EN 166, only requirements and tests for frames and complete eye protectors have been included (see Table 9 of EN 166), that is, not for mounted or unmounted oculars (lenses), with the exception of transmittance and fogging resistance. Optional requirements for frames/complete eye protectors are generally not included. • For the US and ISO standards, in general, requirements for lenses (only) and optional requirements for frames/complete eye protectors have also not been included. Technical regulations and standards for PPE in select markets Note: Testing methods are only mentioned separately when they are not defined in the product standard. (Market) EU US (ISO) standard EN 166:2001 ANSI/ISEA Z87.1:2020 ISO 16321-1:2021 COMPARISON/COMMENTS Testing Requirement Requirement Testing Characteristic/property Testing method Requirement method method EU-US test methods comparable. ISO 18526-3, Construction and materials   Pass Pass Section 9.1 and ANSI Z80.1 Pass ISO comparable to EN; includes clause 6.1 adjustment features ISO 18526-3, Headband   Pass n/a   Pass Different than in EU clause 6.5 Basic/“fundamental” EU refers to “basic” requirements; US refers       TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT requirements to “fundamental design requirements” EN 168 ISO 18526-3, ±30° horizontally Field of vision Pass n/a Different than in EU (clause 18) clause 6.2 and vertically Not a Pass (both An ellipse with ISO 18526-3, Called “area to be protected” in ISO requirement frontal Minimum coverage area axes ≥40 mm and clauses 6.3 except for special ≥ 33mm and lateral & 6.4 uses directions) ≥80% Section 9.2 (use of a ISO 18526-2,  EU-US similar methods; more stringent Transmittance of oculars EN 167 ≥ 85% (or ≥ 78% if spectrophotometer and ≥75% (for face > 74.4% clause 7.1 or requirement in the US; similar ISO without filtering action (clause 6) relaxed optics) weighing factors in Annex shields) C) 7.3 requirements/test method as in EN (Market) EU US (ISO) standard EN 166:2001 ANSI/ISEA Z87.1:2020 ISO 16321-1:2021 COMPARISON/COMMENTS Testing Requirement Requirement Testing Characteristic/property Testing method Requirement method method Section 9.3 and ASTM ISO 18526-2, Called “scattered light” in ISO; similar to Haze n/a n/a ≤3% ≤3% D1003-13 clause 14.1 the US EU-US comparable test methods. Section 9.6 Characteristic in the US is called “drop-ball EN 168 ISO 18526-3, Pass Increased robustness Pass Pass impact resistance” (clause 3.2) clause 7.3.1 Called “basic impact level” in ISO; similar to method in EU EN 168 ISO 18526-3, Called “resistance to thermal exposure” in Thermal stability Pass n/a   Pass (clause 5) clause 6.7 ISO; similar to EU EN 168 ISO 18526-3, Resistance to corrosion Pass Pass Section 9.8 Pass EU, US, and ISO very similar methods (clause 8) clause 6.9 EN 168 ISO 18526-3, Resistance to ignition Pass Pass Section 9.7 Pass EU, US, and ISO very similar methods (clause 7) clause 6.10 Technical regulations and standards for PPE in select markets “Particular requirements” (per EU) Called “optional hazard-   specific requirements” in   the US  No color present In the US, same head forms as in EN 168 No color present for goggles for goggles ISO 18526-3, No color present are used in all tests; EU-US similar test Section 9.17.1 goggles clause 6.12 for droplets methods (droplets) Droplets and splashes of Face shields (droplets) EN 168 Face shields pass liquid (clause 12) pass the area the area coverage coverage test Section 9.17.2 face shields test Clause 6.13 No wetness Same method in ISO as in the EU (for (splashes) (streams of for streams of droplets only); stricter method in ISO than liquids) liquids in EU for splashes TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Similar test methods in the EU and US; in EN 168 the US, only for impact-rated protectors Lateral protection (optional) Pass Pass Section 9.10, Annex D (clause 19) In ISO, covered by property “area to be protected” mentioned earlier Optional requirements (per EU) Resistance to fogging (only Time without Time without ISO 18526-3, for oculars; not complete eye EN 168 Section 9.20 Same requirements/method in EU/US/ISO fogging ≥8 s fogging ≥8 s clause 6.11 protectors) 111 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 4.3 Gloves 4.3.1 Medical examination gloves 4.3.1.1 EU market and ISO standards requirements Standards for medical gloves for single use in the EU currently57 harmonized under the Medical Devices Directive are: • EN 455-1:2000, “Medical gloves for single use—Part 1: Requirements and testing for freedom from holes” (not the latest version) • EN 455-2:2009+A2:2013, “Medical gloves for single use—Part 2: Requirements and testing for physical properties “(not the latest version) • EN 455-3:2006, “Medical gloves for single use—Part 3: Requirements and testing for biological evaluation” (not the latest version) • EN 455-4:2009, “Medical gloves for single use­ —Part 4: Requirements and testing for shelf-life determination” The following highlights are pointed out for the above standards: • EN 455 contains a watertightness test for checking for freedom of holes. In the 2020 version the acceptable quality limit (AQL) for surgical gloves (only) has been reduced from 1.5 to 0.65 (that is, a stricter limit) • EN 455-2 contains dimensional measurements and tensile properties (force at break before and after ageing). The 2015 version removed an exception for nitriles in the force at break limits • EN 455-3 covers biocompatibility requirements, restrictions on chemicals present in the gloves, test for endotoxins (if the gloves are sterile and are additionally labeled with “low endotoxin content”), test for powder residue, test for leachable proteins (associated with the allergenic potential of natural rubber latex products), and immunological methods for the measurement of natural rubber latex allergens (optional). The 2015 version restated the restrictions on chemicals, among others, removing the requirements to achieve levels “as low as reasonably practicable” (ALARP) • EN 455-4 requires manufacturers to test the properties that are reasonably expected to alter over the shelf life of the product (for example, force at break, freedom from holes, and in the case of sterile gloves, pack integrity). Test methods for real-time/accelerated shelf-life determination are provided. Medical gloves are considered medical devices in the EU. Thus, they fall under the scope of the newly applicable (since May 2021) Medical Device Regulation (MDR). For administrative reasons, the above harmonized standards under the previous directive have not yet become harmonized under the new regulation. Therefore, for the time being, they should be used with caution and as an aid in showing conformity to the essential safety and performance requirements of the MDR. It is evident from the above that distinct European standards (parts of the EN 455 series) exist for different characteristics of medical gloves for single use, while in ASTM and ISO standards a single document contains requirements for all characteristics. It is also noted that the EN 455 series includes both surgical and medical examination gloves, with no separate standards for the different materials from which they can be made. However, because this distinction is made in the ASTM (US) and ISO standards, the standard comparison in subsequent sections is done separately for examination and for surgical gloves. While surgical gloves are typically supplied sterile, examination gloves are supplied typically non-sterile. However, there are sterile examination gloves available on the market being used in non-surgical applications where additional protection against the transfer of infective agents is necessary. All medical gloves are Self-declaration Class I in the MDR. However, where sterile, there is a requirement for 57 As of December 31, 2021. 112 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets a notified body to certify the sterilization process. The ISO standards for medical examination gloves are ISO 11193-1:2020, “Single-use medical examination gloves—Part 1: Specification for gloves made from rubber latex or rubber solution,” and ISO 11193-2:2006, “Single-use medical examination gloves—Part 2: Specification for gloves made from poly(vinyl chloride).” ISO 11193-1:2020 is a relatively recent edition, while many national adoptions of it or standards based on it, are still using the previous edition (2008). In the standard, two types of gloves are defined: Type 1, made primarily from natural rubber latex and Type 2, made from various synthetic rubber latexes, emulsions or solutions. Watertightness requirements and method are similar to the EN/US standards while tensile properties (for which different limits apply for Types 1 and 2 gloves) are an amalgam of the requirements in the EU and US standards (see next section). Lastly, from the characteristics regarding biological evaluation (see EN 455-3), only powder residue content has been specified (for the first time) in the 2020 edition of the ISO standard. ISO 11193-2:2006 has similar requirements and testing methods to ISO 11193-1, with the limits of the tensile properties differing somewhat due to the different material of construction (PVC versus rubber). Biocompatibility evaluation to the relevant parts of ISO 10993 is specified but no other biological evaluation is specified (for example, powder residue, extractable plasticizers). It is also noted that PVC does not have the allergenic properties of natural rubber latex. Any of these gloves may be PPE if they claim to protect the wearer and are labeled accordingly. Being a medical glove and a PPE glove are not mutually exclusive, but they must be treated as two separate approvals. The following two standards for protective gloves are used in conjunction with each other. They will not be analyzed in detail but are mentioned here for completeness: • EN ISO 21420:2020, “Protective gloves—general requirements and test methods,” is the new European standard containing general requirements for protective gloves (not yet a harmonized standard under the PPE Regulation, where the superseded EN 420:2003+A1:2009 is listed instead). • EN ISO 374-5:2016, “Protective gloves against dangerous chemicals and micro-organisms: Part 5: Terminology and performance requirements for micro-organism risks.” This standard, in addition to the watertightness test of EN 455-1, provides also for an air leak test and a test for resistance to bloodborne pathogens penetration using ISO 16604. 4.3.1.2 US market requirements The requirements for medical examination gloves in the US market are covered by multiple standards, depending on the material used, as follows: • ASTM D3578 (latex exam gloves) • ASTM D5250 (PVC exam gloves) • ASTM D6319 (nitrile exam gloves) • ASTM D6977 (polychloroprene exam gloves) The existence of different standards for different materials of construction is somewhat mirrored in the ISO standards (see 4.3.1.1) and in this respect is not the same as in the EU. Regarding tensile properties, in the ASTM standards tensile strength is specified (in units of pressure, as opposed to the force at break in the EN/ISO standards), as well as percentage elongation at break, both properties being measured before and after ageing. For rubber gloves, limits for stress (again in pressure units) at a 500 percent elongation are also specified (only before ageing). Lastly, in the ASTM standards references to other ASTM standards containing testing methods are made. Examination gloves are considered by the FDA to be Class I medical devices subject to general controls only (see 21 CFR § 880.6250 as amended). Nevertheless, the FDA requires that examination gloves be subject to a clearance through a 510(k) process except when exemptions are applied during public health emergencies, as has been the case for COVID-19. Also, as of January 2017, the FDA banned powdered examination gloves 113 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets (see 81 FR 9173058). As in the EU/ISO, there are also standards pertaining to gloves which claim to be or are labeled as PPE. Main standards, which will not be analyzed but are mentioned for completeness, are: • ANSI/ISEA 105-2016, “American national standard for hand protection classification,” addresses the classification and testing of hand protection for specific performance properties related to mechanical protection (for example, puncture resistance, including a needlestick puncture test which may happen in a health care environment), chemical protection (for example, permeation resistance), and so on. • NFPA 1999:2018, “Standard on protective clothing and ensembles for emergency medical operations,” which covers requirements for, among others, emergency medical examination gloves (both single- use and multiple-use). Requirements are specified for dexterity, puncture resistance, resistance to bloodborne pathogens penetration, and so on. 58 https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered- patient-examination-gloves-and-absorbable-powder. 114 4.3.1.3 Comparison of EU, US, and ISO criteria Table 4.5 compares the requirements for medical examination gloves in the EU and US standards as well as similarities/differences with ISO standards. Table 4.5: Comparison between EU, US, and ISO standards for medical examination gloves Color code for EU/US comparisons: Green: Same requirement and same (or similar) test methods Yellow: Similar requirement but with different test methods Red: Requirements are more stringent Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: The most recent versions of EN 455 series standards have been used (not all yet harmonized under the PPE Regulation or MDR). Note: Testing standard is only mentioned if it is not defined in the product specification Technical regulations and standards for PPE in select markets US (ISO) ASTM—material specific EU Material specific— (Market) D6319 (nitrile) EN 455 series ISO 11193-1:2020 (rubber) standard D3578 (rubber) Comments ISO 11193-2:2006 (PVC) COMPARISON/COMMENTS D5250 (PVC) D6977 (polychloroprene) Characteristic/ Testing Testing Testing Requirement Requirement Requirement property method method method EU has stricter requirements Freedom from EN 455- AQL =1.5 AQL =2.5 ASTM D5151 than the US/ISO standards; AQL =2.5 holes 1:2020 same test method TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT 115 US 116 (ISO) ASTM—material specific EU Material specific— (Market) D6319 (nitrile) EN 455 series ISO 11193-1:2020 (rubber) standard D3578 (rubber) Comments ISO 11193-2:2006 (PVC) COMPARISON/COMMENTS D5250 (PVC) D6977 (polychloroprene) Characteristic/ Testing Testing Testing Requirement Requirement Requirement property method method method AQL = 4.0 AQL = 4.0 Nitrile ≥ 14MPa/ ISO 11193-1 Types 1 and 2 roughly elongation The US values are after For rubber correspond Types I and II in (Median of 13 ≥400% accelerated ageing (higher ASTM D3578. samples) tensile strength/ elongation ≥ 6.0 N Latex (natural) limits generally apply before Force at break (N) / Elongation ≥ ageing for all materials) ≥ 14MPa / EN 455- 500% (Type 1), ISO rubber limit same as in EU Tensile strength Non-thermoplastic 2 :2015, Elongation ≥ ASTM D412, 400% (Type 2) (but elongation at break is also (MPa), elongation materials ISO 37, Technical regulations and standards for PPE in select markets method 500% ASTM D573 specified) at break (%) EU standards specify ISO 188 A of ISO ≥ 6.0N (ageing) minimum absolute force (N) (Also, after ageing/ 23529:2010 Polychloroprene For PVC for samples taken from the challenge) Thermoplastic In general, the tensile ≥ 14MPa/ glove (varies with thickness); materials (PVC, PE) ≥ 7.0 N properties and their limits elongation ≥ ASTM specifies in terms of tensile strength (MPa – force specified in the ISO standards ≥ 3.6N 400% Elongation ≥ 350% per unit area) are an amalgam of the EU/US (limit for force has ones PVC ≥ 11MPa/ been lowered by elongation ≥ about 50% in the 300% EU) EN ISO Per FDA Generally similar Biocompatibility 10993-5 and Pass Pass Pass ISO 10993 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT regulations methodology -10 series Only for rubber ≤ 2.0mg/glove gloves Limits and method same (powder free EN 455-3, gloves) (for powder-free gloves); ≤ 2.0mg/glove Powder residue (powder free Limits have first been specified EN ISO ≤ 2.0mg/glove ASTM D6124 powdered gloves have been ISO content ≤ 10 mg/dm2 gloves) in the 2020 edition of ISO 11193-1 21171:2006 disallowed in the US by the (powdered gloves) FDA ≤ 10 mg/dm2 (powdered gloves) “Manufacturer shall monitor the content ≤ 200 µg/dm2 Unlike the US, the EU does Aqueous soluble n/a (may be in natural rubber not mention specific limits; EN 455-3 ASTM D5712 specified in future protein content latex (NRL) gloves (only for rubber methods are essentially the edition) and shall try to gloves) same minimize it” US (ISO) ASTM—material specific EU Material specific— (Market) D6319 (nitrile) EN 455 series ISO 11193-1:2020 (rubber) standard D3578 (rubber) Comments ISO 11193-2:2006 (PVC) COMPARISON/COMMENTS D5250 (PVC) D6977 (polychloroprene) Characteristic/ Testing Testing Testing Requirement Requirement Requirement property method method method In the EU, measuring this ≤ 10 µg/dm2 n/a (may be Extractable EN 455-3, characteristic is optional; antigenic protein Optional ASTM D6499 specified in future Annex B (only for rubber (immunological) method content edition) gloves) essentially same If gloves are sterilized, the EN 455-4 refers to Pass nature of the EN ISO 11607 (sterile US Sterility sterilization barrier integrity Pharmacopeia process shall Technical regulations and standards for PPE in select markets during shelf-life) be disclosed on request TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT 117 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 4.3.2 Surgical gloves 4.3.2.1 EU market and ISO standard requirements The same basic standards of the EN 455 series that apply to medical examination gloves also cover surgical gloves. Further details can be found in 4.3.1.1. The relevant ISO standard is ISO 10282:2014. In the standard two types of gloves are defined: Type 1, made primarily from natural rubber latex and Type 2, made from various synthetic rubber latexes, emulsions, or solutions. Watertightness requirements and methods are similar to the EN/US standards while tensile properties (for which different limits apply for Types 1 and 2 gloves) are an amalgam of the requirements in the EU and US standards (see below section). If claimed or labeled as PPE, surgical gloves fall within the scope of the EN ISO standards for “protective gloves” mentioned in 4.3.1.1. 4.3.2.2 US market requirements The main standard used in the US market is ASTM D3577-19 “Standard specification for rubber surgical gloves.” In the standard, Type 1 gloves (made from natural rubber latex) and Type 2 (made from a rubber cement or from synthetic rubber latex) are defined. Otherwise, the requirements and test methods are similar to those for the medical examination gloves (see 4.3.1.2). Another useful standard is ASTM 7103-19 “Standard guide for assessment of medical gloves” covering both medical examination and surgical gloves. Surgical gloves are considered by the FDA to be Class I medical devices, subject to general controls only (see 21 CFR § 878.4460 as amended). Also, as of January 2017, FDA banned powdered surgical gloves (see 81 FR 91730). 4.3.2.3 Comparison of EU, US, and ISO criteria Table 4.6 compares the requirements for surgical gloves in the EU and US markets as well as similarities/ differences with ISO standards. 118 Table 4.6: Comparison between EU, US, and ISO standards for surgical gloves Color code for EU/US comparisons: Green – Same requirement and same (or similar) test methods Yellow – Similar requirement but with different test methods Red – Requirements are more stringent Blue – Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: The most recent versions of EN 455 series standards have been used (not yet harmonized under the PPE Regulation or MDR). Note: Testing methods are only mentioned separately when they are not defined in the product standard. US (ISO) COMPARISON/ EU (Market) ASTM D3577-19 ISO 10282:2014 COMMENTS EN 455 series standard Type 1: Natural rubber Type 1: Natural rubber Type 2: Synthetic rubber Comments Type 2: Synthetic rubber Note: Similar types defined Characteristic/ Testing Testing Testing in ISO as in the US (EU does Requirement Requirement Requirement Technical regulations and standards for PPE in select markets property method method method not differentiate) Freedom from EN 455- Latest version of EN 455-1 is AQL = 0.65 AQL = 1.5 ASTM D5151 AQL = 1.5 holes 1:2020 stricter than before The US values are after AQL = 4.0 accelerated ageing (higher tensile strength/ elongation Force at break AQL = 4.0 limits generally apply before The ISO values are after (Median of 13 Type 1: Latex (natural) (N) / ageing for all materials) accelerated ageing (higher EN 455- samples) Type 1: Latex ≥9.5 N/elongation limits apply before ageing) Tensile strength 2 :2015, (natural) ≥18MPa/ ASTM D412, All materials ≥550% ISO 37, ISO (MPa), elongation method elongation ≥560% ASTM D573 ISO tensile properties EU standards specify 188 (%) A of ISO ≥ 9.0N (ageing) specified and their limits 23529:2010 Type 2: Synthetic minimum absolute force (N) are an amalgam of the ones (Also, after rubber ≥12Mpa/ for samples taken from the Type 2: synthetic in the EU/US TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT ageing/challenge) elongation ≥490% glove (varies with thickness); rubber ASTM specifies in terms of tensile strength (MPa—force ≥9.0N/elongation per unit area) ≥500% EN ISO Passes (generally Per FDA ISO 10993- Biocompatibility 10993-5 and Pass Pass Generally similar methodology similar methodology regulations 1 -10 with EU/US) EN 455-3, Limits and method same; Powder residue n/a (may be specified EN ISO ≤ 2.0 mg/glove ≤ 2.0mg/glove ASTM D6124 surgical gloves can only be content in future edition) 21171:2006 powder free “Manufacturer shall monitor the Unlike the US, the EU does not Aqueous soluble EN 455-3, n/a (may be specified content in NRL ≤ 200 µg/dm2 ASTM D5712 give specific limits; method protein content Annex A in future edition) gloves and shall try essentially same to minimize it” 119 US (ISO) COMPARISON/ EU 120 (Market) ASTM D3577-19 ISO 10282:2014 COMMENTS EN 455 series standard Type 1: Natural rubber Type 1: Natural rubber Type 2: Synthetic rubber Comments Type 2: Synthetic rubber Note: Similar types defined Characteristic/ Testing Testing Testing in ISO as in the US (EU does Requirement Requirement Requirement property method method method not differentiate) In the EU, measuring this Extractable EN 455-3, 2 characteristic is optional; n/a (may be specified antigenic protein Optional ≤ 10 µg/dm ASTM D6499 Annex B (immunological) method in future edition) content essentially same Gloves shall be EN 455-4 refers sterilized; the nature to EN ISO 11607 Pass of the sterilization No specific US Sterility (sterile barrier process shall be method Pharmacopeia integrity during disclosed on request. provided shelf-life) Technical regulations and standards for PPE in select markets TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 4.4 Clothing This section covers the requirements for all the categories of protective clothing described in, which are subject to similar core requirements regardless of their specific application. However, it is important to differentiate between protective clothing (under the PPE Regulation) and surgical or isolation gowns (under the MDR). Because of this differentiation, 4.4 is split into sections 4.4.1 for protective clothing (PPE for full- or partial- body protection) and 4.4.2 for gowns (medical devices). The reader is reminded that, as mentioned in 1.4.1, depending on the claims made by the manufacturer, a product may need to cover both sets of requirements. 4.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) 4.4.1.1 EU market requirements The core standard is EN 14126:2003, “Protective clothing against infective agents,” which includes the following infective agent seam and material tests: • ISO 16603:2004, “Clothing for protection against contact with blood and body fluids— determination of the resistance of protective clothing materials to penetration by blood and body fluids—test method using synthetic blood” (indicator test for ISO 16604), Classes 1–6, 0 to 20 kPa (barrier test) • ISO 16604:2002 “Resistance of protective clothing materials to penetration by bloodborne pathogens using Phi-X174 bacteriophage,” Classes 1–6, 0 to 20 kPa (barrier test) • EN ISO 22610:2006, “Surgical gowns, resistance to wet bacterial penetration,” Classes 1–6 (breakthrough times) • ISO/DIS 22611 (never published), “Resistance to penetration by contaminated liquid aerosols,” Classes 1­ –3 (quantitative breakthrough) • EN ISO 22612:2005, “Clothing, resistance to dry microbial penetration,” Classes 1–3 (quantitative breakthrough). Other relevant standards, harmonized under the PPE Regulation, include: • EN 14605:2005+A1:2009, “Protective clothing against liquid chemicals—performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])” • EN 13034:2005+A1:2009, “Protective clothing against liquid chemicals—performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)” • EN ISO 13688:2013+A1:2021,59 “Protective clothing—general requirements.” EN 14126 provides requirements for protection from infectious agents (including COVID-19) for both full- and partial-body garments. EN 14126 calls up in clause 4.3 the relevant general protective clothing requirements from EN 340 (now EN ISO 13688) and the requirements from the chemical protective clothing types in Table 4.7. 59 As of December 31, 2021, the amendment had not yet been harmonized under the PPE Regulation. 121 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 4.7: Types of chemical protection clothing Type of clothing Common suit name PB option Relevant current standard Gas tight for Types 1 EN 943-1:2015+A1:2019 (Type 1) Type 1a, 1b, 1c, 2 No EN 943-1:2002 (Type 2) Ventilated gas tight for Type 2 EN 943-2:2019 (Type 1 ET) Type 3 Jet or splash tight Yes EN 14605:2005+A1:2009 Type 4 Spray or light splash tight Yes EN 14605:2005+A1:2009 Type 5 Dust tight No EN 13982-1:2004+A1:2010 Type 6 Light spray tight Yes EN 13034:2005+A1:2009 It is pointed out that EN 14126:2003 (the standard for protective clothing against infective agents) must be associated with a chemical suit “type” standard for material mechanical performance, regardless of whether or not chemical protection is claimed. Partial-body protection (PB), for example, aprons or head/ shoe covers, is only available with “Types” 3, 4 and 6. Suit “Types” 3, 4, 6, PB [3], PB [4] and PB [6] refer to test methods from EN 14325:2004 (this is the version referenced by the harmonized EN 14126—a 2018 version of EN 14325 has also been issued). In combination, the above standards provide for tests regarding: • Innocuousness and design/comfort • Properties of materials (mechanical, flammability, chemical resistance, and resistance to penetration by infective agents) • Properties for seams (parts of the construction of integral parts of the garment), joins (between integral parts of the garment) and assemblages (of different garments or of garments and accessories, detachable or not) • Whole-suit requirements • Accessories (for example, visors). As already mentioned, aprons and head/shoe covers, if they claim to offer partial-body protection, are considered PPE. As such, they should comply with the requirements above applicable for innocuousness, design/comfort and materials only. (See also table in 4.4.1.3, where all sets of requirements are included.) Additionally, it is noted the international standard ISO 16602:2007+A1:2012, “Protective clothing for protection against chemicals—classification, labeling and performance requirements,” does not address protection against infective agents and is only relevant for mechanical/chemical properties of materials and suit integrity as relates to COVID-19 protection. Of course, other ISO standards (ISO 16603, ISO 16604, ISO 22610, and ISO 22612 mentioned previously in this section) constitute the basic suite of testing methods for resistance to infective agents. Lastly, for single-use aprons and head/shoe covers, the following standard is optionally applicable (for biodegradable products): EN 13432:2000, “Packaging—requirements for packaging recoverable through composting and biodegradation—test scheme and evaluation criteria for the final acceptance of packaging” (currently under revision). The standard includes references to appropriate test methods. 4.4.1.2 US market requirements Requirements for protective garments in the United States in the scope of this guide are addressed mainly by NFPA 1999:2018, “Standard on protective clothing and ensembles for emergency medical operations.”60 The 60 Another standard for chemical protection is NFPA 1992“Standard on liquid splash-protective ensembles and clothing for hazardous materials emergencies.” 122 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets scope of the standard is quite broad, encompassing emergency medical garments and related accessories (that is, eye/face protection, gloves, helmets, and footwear), both single- and multiple-use. The standard contains design and performance requirements, as well as some test methods (for other tests, reference is made to established ASTM or other standards). Examples of requirements include: • Mechanical properties of materials (for example, tear resistance, tensile strength, but not abrasion and flex cracking resistance included in EN 14126) • Liquid integrity test (per ASTM F1359) • Bio-penetration resistance (per ASTM F1671, on which ISO 16604—used in the EU—was based), but not dry/wet bacterial penetration resistance provided for in EN 14126. It is noted that in the United States gowns used in health care settings typically are not covered by NFPA 1999—which is more suited to emergency response situations— but comply to a different set of standards (see 4.4.2.2). Conformity assessment of products within the scope of NFPA 1999 must be provided by third-party product certification bodies. Lastly, for single-use aprons and head/shoe covers, the following standard is optionally applicable (for biodegradable products): ASTM D6400-19, “Standard specification for labeling of plastics designed to be aerobically composted in municipal or industrial facilities.” 4.4.1.3 Comparison between EU, US market, and ISO requirements Table 4.8 compares the requirements for protective clothing in the EU and US markets as well as similarities/ differences with ISO standards. 123 Table 4.8: Comparison between EU, US, and ISO standards for protective clothing 124 Color code for EU/US comparisons: Green: Same requirement and same (or similar) test methods Yellow: Similar requirement but with different test methods Red: Requirements are more stringent Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Notes: • For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components such as visors are not included). • For protection against infective agents, only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection—Type 4), Type 6 (limited protection against liquid chemicals), and Type PB [6] (partial-body protection—Type 6). Technical regulations and standards for PPE in select markets Note: Testing methods are only mentioned separately when they are not defined in the product standard. (Market) EU US ISO COMPARISON/ standard COMMENTS Characteristic/ Testing method Requirement Requirement Testing method Requirement Testing method property I. General Standard EN ISO 13688:2013+ NFPA 1999:2018 ISO 13688:2013+AMD requirements A1:2021 1:2021 Innocuousness General No harmful No specific No harmful substances General assessment ISO/EU: Same limits/ assessment substances present requirements present methodology in Annex B methods methodology in Annex B. No azo dyes present No azo dyes present Azo dyes according to ISO 14362-1 and ISO 14362-3 Azo dyes according TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT to EN ISO 14362-1 Note: Also cl. 4.3 of EN 14126 (Market) EU US ISO COMPARISON/ standard COMMENTS Characteristic/ Testing method Requirement Requirement Testing method Requirement Testing method property Design and Assessment in Acceptable Acceptable Section 6.1 Assessment in Annex C Acceptable Same requirements; comfort Annex C Note: Design similar methodology as in requirements only Section 8.28 and ASTM EU/ISO/US ≥650 g/(m224 h) E96 Note: In the US for single-use garments/ ensembles “moisture vapor transmission rate” is specified Section 8.32 and ASTM F1868 ≥450 W/m2 Note: In the US for multiple-use Technical regulations and standards for PPE in select markets garments/ensembles “total heat loss test” is specified Standard EN 14126:2003 NFPA 1999:2018 ISO ISO 16602 is really about II. Protection and EN 16602:2007+AMD1:2012 protective clothing 14605:2005+A1:2009 against chemicals— against (for Type 4 and not against infective infective PB [4]) or EN agents; requirements on agents 13034:2005+A1:2009 mechanical properties (for Type 6 and PB and chemical resistance [6]) of materials are included, as well as whole-suit requirements 1.Materials requirements TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT a) Mechanical properties Abrasion cl. 4.4 of EN 14325 Class 1 to 6 (highest) Abrasion resistance ASTM D4157 Class 1 to 6 (highest) ISO 12947-2 EU/ISO: Same limits/ resistance & EN ISO 12947-2 is considered as essentially same method a precondition to Note: Reference barrier performance in this column to of materials EN 14325 without a year, means the current edition (2018) Note: In EN 14325:2004, instead use EN 530 125 (Market) EU US ISO COMPARISON/ 126 standard COMMENTS Characteristic/ Testing method Requirement Requirement Testing method Requirement Testing method property Flex cracking cl. 4.5, 4.6 of EN Class 1 to 6 (highest) Flex fatigue is ASTM F392 Class 1 to 6 (highest) ISO 7854, method B EU/ISO: Same limits/ resistance 14325 and EN ISO considered as a essentially same method precondition to 7854, method B barrier performance of materials Trapezoidal tear cl. 4.7 of EN 14325 Class 1 to 6 (highest) Single-use: “Tear Section 8.38 and ASTM Class 1 to 6 (highest) ISO 9073-4 EU/ISO: Same limits/ resistance and EN ISO 9073- resistance test two” D5733 (non-woven) essentially same method ≥17 N Section 8.7 & ASTM 4:1997 D5587 (woven) Multiple-use: “Tear resistance test one” ≥36 N Tensile strength cl. 4.9 of EN 14325 Class 1 to 6 (highest) ≥50 N Section 8.4 and ASTM Class 1 to 6 (highest) ISO 13934-1 For tensile strength ASTM and EN ISO 13934-1 D5034 limits/method not directly comparable to EU/ISO Note: Additionally Technical regulations and standards for PPE in select markets ≥66N (single-use) Section 8.5 and ASTM Class 1 to 6 (highest) ISO 13938-1 (which are same) bursting strength, ≥222.5N (multiple- D3787 cl. 4.8 of EN use) Burst strength is an 14325:2004 and EN ISO 13938-1 additional US/ISO requirement (was eliminated in the EU) Puncture cl. 4.10 of EN 14325 Class 1 to 6 (highest) ≥12N (single-use) Section 8.6 and ASTM Class 1 to 6 (highest) ISO 13996 ASTM limits/method not resistance and EN 863 ≥25N (multiple-use) D2572 directly comparable to EU or ISO b) Chemical resistance Permeation by EN ISO 6529, Class 1 to 6 (highest) Class 1 to 6 (highest) ISO 6529, method A EU/ISO: Same limits/ chemicals method A (liquids) essentially same TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT method in ISO 16602. (Applicable for Note: In EN Alternatively, resistance Types 4 and 14325:2004 also EN to penetration by liquids PB[4]) 374-3 under pressure (per ISO 13994:2005, Procedure D) is applied Repellency to ISO 6530 Class 1 to 3 (highest) ≤30% Section 8.31 Class 1 to 3 (highest) ISO 6530 Note: In the US it is liquids called “water absorption resistance test.” It applies (Applicable to only to multiple-use Types 6 and garments/ensembles PB[6]) EU/ISO: Same limits/ essentially same method (Market) EU US ISO COMPARISON/ standard COMMENTS Characteristic/ Testing method Requirement Requirement Testing method Requirement Testing method property Penetration by ISO 6530 Class 1 to 3 (highest) Class 1 to 3 (highest) ISO 6530 EU/ISO: Same limits/ liquids essentially same method (Applicable to Types 6 and PB[6]) c) Flammability Resistance cl. 4.14 of EN 14325 Pass or min. class 1 Flame spread time: Section 8.39 & ASTM n/a Requirement eliminated to ignition or & EN 13274-4, ≥3.5 s D1230 by ISO 16602 AMD 1:2012 flame (more method 3 stringent) d) Penetration No relevant Technical regulations and standards for PPE in select markets by infective requirements in ISO 16602 agents Contaminated Clause 4.1.4.1 of EN Class 1 to 6 (highest) Pass Section 8.3 & ASTM Requirement does not ASTM method and ISO liquids under 14126, ISO 16603 Note: In the US the F1671 apply in ISO 16602 (ISO 16604 are very similar and ISO 16604 “bio-penetration test 16603 and 16604 are hydrostatic one” only laboratory method pressure applies standards) Mechanical Clause 4.1.4.2 of EN Class 1 to 6 (highest) n/a n/a contact with 14126 and EN ISO contaminated 22610 liquids (wet bacterial penetration) TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT (Biologically) Clause 4.1.4.3 of EN Class 1 to 3 (highest) n/a n/a contaminated 14126 and ISO/DIS liquid aerosols 22611 (withdrawn) Contaminated Clause 4.1.4.4 of Class 1 to 3 (highest) n/a n/a solid particles EN 14126 and ISO (dry microbial 22612 penetration) 2. Whole-suit requirements Mist test (Type EN ISO 17491-4 Pass Pass Section 8.2 Pass ISO 17491-4 (method A) EU/ISO: Same limits/ 6) (method A) as essentially same method Note: In the US the modified by cl. 5.2 “liquid tight integrity of EN 13034 test one” applies 127 (Market) EU US ISO COMPARISON/ 128 standard COMMENTS Characteristic/ Testing method Requirement Requirement Testing method Requirement Testing method property Liquid spray test Clause 4.3.4.2 etc. Pass Pass Section 8.2 Pass ISO 17491-4 (method B) EU/ISO: Same limits/ (Type 4) of EN 14605 and essentially same method EN ISO 17491-4 (method B) Practical Per EN 14605/ Pass Demonstration ASTM F1154 Pass ISO 16602, Annex A EU/ISO: Same limits/ performance EN 13034 (“seven of garment essentially same method functionality is movements” included as part of sequence while the liquid integrity wearing the suit) testing applied to garments Technical regulations and standards for PPE in select markets TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 4.4.2 Gowns 4.4.2.1 EU market requirements Requirements for gowns used in health care settings are included in EN 13795-1:2019, “Surgical clothing and drapes—requirements and test methods— Part 1: Surgical drapes and gowns.” It is noted that, unlike in the United States, only a standard for surgical gowns exists. Therefore, in this subsection, by “gown” a “surgical gown” is meant. The standard covers both single-use and reusable gowns. Requirements in the standard include: • Mechanical properties (for example, liquid penetration, tensile strength, bursting strength) • Resistance to wet bacterial penetration (due to a combination of wetness, pressure and rubbing) and dry microbial penetration (due to a combination of air movement and mechanical action by vibration) • Microbial burden (it also possible that gowns are provided sterile). The standard recognizes two levels of performance: “standard” and “high” and also differentiates between “critical product areas” of the garment and “less critical product areas.” Critical product areas are defined as those with a greater probability to be involved in the transfer of infective agents to or from the wound, for example, the front and sleeves of surgical gowns. The applicable requirements depend on both the performance level and the critical/less critical areas. The conformity assessment of gowns is done under the requirements of the EU Medical Devices Regulation (MDR) (EU) 2017/745. In fact, EN 13795-1 is harmonized under the previously valid EU Medical Devices Directive, but, as of 31 December 2021, not yet under the new regulation. Additionally, EN 13795-1 is not harmonized under the PPE Regulation, which means that if claims for PPE are made for a product, compliance to the requirements of EN 14126 (see 4.4.1.1) has to be checked. 4.4.2.2 US market requirements For the definition and an overview of isolation and surgical gowns, the reader is referred to 2.4.2 of the guide. The key standard is ANSI/AAMI PB70:2012, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.” The scope of the standard encompasses single- and multiple-use gowns, sleeve protectors and aprons but not surgical caps or foot covers. The standard defines four levels of barrier performance: 1 to 4 (highest). Regarding barrier properties: Level 1 meets a water impact test; Levels 2 and 3 both meet water impact and hydrostatic pressure tests (higher limit for the latter for Level 3); and Level 4 must meet a resistance to bloodborne pathogens test (per ASTM F 1671), similar to ISO 16604. All levels must also meet other requirements specified in ASTM F2407-20 for surgical gowns and ASTM F3352- 19 for isolation gowns, respectively. For isolation gowns, properties such as tensile and seam strength are tested for, while, optionally, lint generation, comfort properties (for example, water vapor transmission rate or evaporative resistance), and physical properties (for example, abrasion resistance, flex durability) are also measured. Tests for surgical gowns are very similar, but some differences exist. Finally, for surgical gowns, when provided sterile, the selected sterilization process shall have a sterility assurance level of at least 10-6. Gowns used in health care settings are regulated as medical devices by the FDA. Both isolation and surgical gowns are Class II products (when Levels 3 or 4) subject to a pre-market (510(k)) notification. The simpler examination gowns are Class I products, subject only to general controls. 4.4.2.3 Comparison between EU and US market requirements Table 4.9 compares the requirements for protective clothing in the EU and US markets. 129 Table 4.9: Comparison between EU and US standards for gowns 130 Color code for EU/US comparisons: Green: Same requirement and same (or similar) test methods Yellow: Similar requirement but with different test methods Red: Requirements are more stringent Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Notes: • In the EU, specifications are defined for four situations: critical/less critical areas and standard/high performance. Unless otherwise specified, all areas and/or performances are implied. • Both in the EU and the United States, single- and multiple-use surgical gowns are permitted. Multiple-use isolation gowns are also permitted in the US. Technical regulations and standards for PPE in select markets • Isolation gowns differ from surgical gowns based on their intended use and the expectation that the isolation gown provides 360° protection to the health care worker. • For isolation gowns, the critical zone comprises the entire gown and must have a barrier performance of at least Level 1. Note: Testing methods are only mentioned separately when they are not defined in the product standard. US EU (Market) ANSI/AAMI PB70:2012: All gowns EN 13795-1:2019, COMPARISON/COMMENTS standard ASTM F3352-19: Isolation gowns Surgical gowns ASTM F2407-20: Surgical gowns Characteristic/ Testing method Requirement Requirement Testing method property ≤ 300 CFU (less critical TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT areas) Resistance to dry AAMI PB 70 standard specifically excludes dry microbial EN ISO 22612:2005 Note: For critical product n/a microbial penetration penetration from its scope areas, wet bacterial penetration limits apply instead IB ≥ 2.8 (critical areas, Resistance to wet standard performance) US requires (only for Level 4) a stricter characteristic (viral EN ISO 22610:2006 n/a bacterial penetration penetration; see next row in table) IB = 6.0 (critical areas, high performance) Pass (AQL 4%, RQL=20%) Viral penetration n/a ASTM F1671 (AAMI Level 4) EN ISO 11737-1:2018 Cleanliness microbial/ ≤ 300 CFU/100 cm2 n/a bioburden US EU (Market) ANSI/AAMI PB70:2012: All gowns EN 13795-1:2019, COMPARISON/COMMENTS standard ASTM F3352-19: Isolation gowns Surgical gowns ASTM F2407-20: Surgical gowns Characteristic/ Testing method Requirement Requirement Testing method property Particle release EN ISO 9073-10:2004 Log10 (lint count) ≤ 4.0 Optional in the US ≥ 20 cm H2O (critical areas, ≥ 20 cm H2O std. performance) (AAMI Level 2) For critical areas/zones, US limits are same as EU ones (for standard performance) or lower (for high performance) Water resistance ≥ 100 cm H2O (critical areas, ≥ 50 cm H2O EN ISO 811:2018 AATC 127 Limits in the US apply only to critical zone components (hydrostatic pressure) high performance) (AAMI Level 3) (akin to critical areas in the EU); EU and US methods are ≥ 10 cm H2O (less critical (AQL 4%, similar areas) RQL=20%) ≤ 4.5 g (AAMI Level AATC 42 or NWSP 1) 80.3 Limits in the US apply only to critical zone components Water resistance ≤ 1.0 g (AAMI Levels NWSP 80.3 has (akin to critical areas in the EU) n/a (impact penetration) 2, 3) replaced WSP 80.3 Technical regulations and standards for PPE in select markets mentioned in AAMI (AQL 4%, PB 70 std. RQL=20%) EN ISO 13938:1:1999 Bursting strength (dry) ≥ 40 kPa Note: Newer version of the standard exists but (wet) is not referenced in EN ≥ 40 kPa (critical areas) 13795-1 Higher limit in the US compared to the EU. Additionally, ≥ 20 N Tensile strength (dry) limits are set for tear strength (≥ 10 N per ASTM D5587 or EN 29073-3:1992 ≥ 20 N (critical areas) ≥ 30 N ASTM D5034 D5733) and seam strength (≥ 30 N per ASTM D1683/D1683M). (wet) Physical property limits are same for all barrier levels per AAMI TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT ANSI/AAMI BE78 or Biocompatibility EN ISO 10993-1:2009 Pass Pass ISO 10993-10 Packaging for terminally Assurance level sterilized medical devices is of sterilization Sterility recommended according to process: at least EN ISO 11607 series 10-6 Manufacturer to provide fire Flammability Class 1 16 CFR 1610 risk information Optional: - Water vapor Comfort (depends on a transmission Other criteria to variety of properties) Rate (ASTM D6701) consider - Evaporative resistance (ASTM F1868, Part B) - etc. 131 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 5 PRODUCT-SPECIFIC COMPARISONS (AUSTRALIA) 5.1 Masks 5.1.1 Respirators The Australian standard on respirators is the Joint Australian/New Zealand Standard (AS/NZS) 1716:2012, “Respiratory protective devices.” The standard covers many types of respirators (for example, against chemicals, particles, and so on). In this guide only Types P2 and P3 are included, with filtration efficiencies similar to the National Institute for Occupational Safety and Health (NIOSH) N95 and N99, other types being unsuitable for use in the COVID-19 context. The applicable sections of the standard are: • Design and construction of assembled respirators • Face pieces head coverings and harnesses • Particulate filter respirators • Marking and instructions Test methods are included in appendices of the standard. A good overview of the applicable requirements and test methods is provided the informative Appendix P “Summary of conditioning and testing requirements.” It is envisioned that the AS/NZS will be replaced in future by the AS/NZ adoptions of the ISO 17420 series (specific performance requirements) and ISO 16900 series (test methods).61 Table 5.1 shows the requirements for respirators in the Australian market compared to those of the EU and US markets. 61 https://www.standards.org.au/news/new-guidance-for-respiratory-protective-equipment-released. 132 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 5.1: Comparison between EU, US, and Australian standards for respirators Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 of this guide. Color code: Green: Products made to the Australian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Australian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed —products made to the Australian standard are not likely to meet the Red: Significantly different criteria­ EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. EU EN 149:2001 Australia US (Market) +A1:2009, AS/NZS 1716:2012, 42 CFR Part 84, COMPARISON/COMMENTS standard Classes FFP 2 and Classes P2 and P3 Series/Levels N95 and N99 FFP 3 Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method Facial fit is determined Pass (based on 2 Fit testing before use Practical during Total inward subjects performing (required by OSHA, not performance leakage test (cl. 2.2 of various tasks) NIOSH) AZ/NZS) FFP2 P2 Stricter limits in AS/NZS; ≤ 11% (individual) ≤ 8% (individual) n/a method (using NaCl aerosol ≤ 8% (mean) ≤ 8% (mean) only) similar to EU test method Total inward P3 leakage FFP3 ≤ 5% (individual) ≤ 5% (individual) ≤ 5% (mean) n/a ≤ 2 % (mean) (Appendix D of AZ/NZS 1712) FFP2 P2 N95 ≥ 94% @ 95 L/min ≥ 94% @ 95 L/min (NaCl) ≥ 95% Specified as max penetration of (NaCl and paraffin oil, (Appendix I of AS/NZS @ 85 L/min (NaCl only) 6% in the EU and Australia (EN 13274-7) 1712) Specified as max penetration of 1% (EU) or 0.05% (AU), Filtering P3 N99 respectively efficiency FFP3 ≥ 99.95% @ 95 L/min ≥ 99% ≥ 99% @ 95 L/min (NaCl) @ 85 L/min Test methods of AS/NZS are (NaCl and paraffin oil, (Appendix I of AS/NZS (NaCl only) somewhat different from EU (EN 13274-7) 1712) criteria but performance criteria are similar (like US, Australia tests with NaCl only) Compatibility Pass Pass n/a with skin (Cl. 2.1.2 of AS/NZS 1712) Only when a relevant claim is made Test method similar to the EU Flammability Pass Pass n/a one (Appendix C of AS/NZS 1712) Average ≤ 1% by Carbon dioxide Average ≤ 1% by volume in “dead space” Test method similar to the EU n/a content volume in ‘dead space’ (Appendix E 5.3 of AS/ one NZS 1712) Pass (in the practical Field of vision No explicit requirement Pass performance test) 133 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets EU EN 149:2001 Australia US (Market) +A1:2009, AS/NZS 1716:2012, 42 CFR Part 84, COMPARISON/COMMENTS standard Classes FFP 2 and Classes P2 and P3 Series/Levels N95 and N99 FFP 3 Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method P2 ≤ 70 Pa @ 30 L/min Limits same; test method FFP2 ≤ 240 Pa @ 95 L/min N95 similar to the EU one ≤ 70 Pa @ 30 L/min; ≤ 343 Pa @ 85 L/min ≤ 240 Pa @ 95 L/min (Appendix G of AS/NZS Breathing 1712) resistance P3 Test method similar to the EU (inhalation) ≤ 120 Pa @ 30 L/min one, but limits are less strict. FFP 3 ≤ 420 Pa @ 95 L/min This is justified because P3 has N99 ≤ 100 Pa @ 30 L/min a higher filtration efficiency ≤ 343 Pa @ 85 L/min ≤ 300 Pa @ 95 L/min (Appendix G of AS/NZS requirement than FFP3 1712) P2 ≤ 120 Pa @85 L/min Test method similar to the P3 EU one but limits cannot be Breathing ≤ 300 Pa @85 L/min compared; a stricter requirement resistance ≤ 300 Pa @160 L/min ≤ 245 Pa @ 85 L/min (when full face) applies in the US (exhalation) (Appendix G of AS/NZS 1712) Strap withstands a force of 10N (150N) for 10s for Security of P2 (P3-when full face) n/a n/a Only a requirement in Australia attachments masks (Clause 3.2.6 of AS/NZS 1712) Respirators claimed for use in health care settings in Australia are regulated as medical devices (Class I); see 3.3.1. 5.1.2 Medical face masks The relevant standard, AS 4381:2015, “Single-use face masks for use in health care,” has requirements from the product standard EN 14683 (2014 edition) and also refers to test methods in that standard or to ASTM testing standards (previous editions). It defines Levels 1, 2 and 3, approximately corresponding to the same levels of barrier protection in the United States (standard ASTM F2100; see 4.1.2.2). As with in the United States, all levels exhibit splash resistance (with identical limits to the US standards) but, unlike in the United States, particulate filtration efficiency is not specified. Finally, as in the US standard, bioburden and biocompatibility are not explicit requirements. Table 5.2 shows the requirements for medical face masks in the Australian market compared to those of the EU and US markets. 134 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 5.2: Comparison between EU, US, and Australian standards for medical face masks Note: For a detailed comparison of EU and US standards (including test methods), see 4.1.2. Color code: Green: Products made to the Australian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Australian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Australian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. EU Australia US (Market) EN 14683:2019, AS 4381:2015, ASTM F2100 – 21, COMPARISON/COMMENTS standard Type I, II and IIR Levels 1, 2 and 3 Levels 1, 2 and 3 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method ≥ 95% (Level 1) ≥ 95% (Type I) ≥ 95% (Level 1) Appendix B of EN 14683 has Bacterial filtration ≥ 98% (Level 2, 3) ≥ 98% (Types II, IIR) ≥ 98% (Level 2, 3) been updated in the 2019 efficiency (BFE) Using ASTM F2101-14 or Using ASTM F2101 edition Appendix B of EN 14683:2014 Limits in AU are stricter < 40 Pa/cm2 (Types than the EU/US ones (for <39.2 Pa/cm2 (Level 1) <49 Pa/cm2 (Level 1) I, II) corresponding types/levels) Differential <49.0 Pa/cm2 (Level 2 and Note 1: Specified as 4.0 mm and < 60 Pa/cm2 (Types 3) <58.8 Pa/cm2 (Level pressure IIR) 5.0 mm H2O/cm2, respectively 2, 3) Note 1: Using EN (Tested at 8L/min 14683:2014, Appendix C Using EN 14683 EN 14683:2019 Appendix C flowrate) has been completely revised compared to the 2014 version ≥ 95 (Level 1) Sub-micron particulate ≥ 98 (Level 2,3) filtration efficiency n/a n/a Both at 0.1 micron, using ASTM F2299 ≥ 10.7 kPa (Level 1) ≥ 10.7 kPa (Level 1) Not required Types Same limits/method as in US I, II) ≥16 kPa (Level 2) ≥16 kPa (Level 2) Splash-resistance Note 2: Specified as ≥ 80, ≥120 pressure ≥21.4 kPa (Level 3) ≥ 16.0 kPa (Type IIR) ≥21.4 kPa (Level 3) and ≥160 mm Hg, respectively Note 2 Using ISO 22609:2004 Using ASTM F1862 Using ASTM F1862/ F1862M-13 or ISO 22609 ≤ 30 CFU/g Microbial No explicit requirement n/a cleanliness Using EN ISO 11737- 1:2018 Pass Pass Biocompatibility Using ISO EN 10993- No explicit requirement Using ISO 10993-1 1:2009 Class 1 Flame spread n/a n/a Using 16 CFR Part 1610 Medical face masks used in health care settings in Australia are regulated as medical devices (Class I or, if sterile, Class Is; see 3.3.1.) 135 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 5.1.3 Community face coverings According to the Australian Commission on Safety and Quality in Healthcare,62 “you can use a cloth mask or a single-use surgical mask. Both types of masks are suitable for use to prevent the spread of COVID-19. Masks do not need to be surgical quality to be effective. Cloth masks are any nose and mouth covering made of washable fabric that you can breathe through. Surgical masks are single-use, so can’t be washed and used again.” However, since there is no relevant Australian Standard, no comparison to EU/US standards is made. 5.2 Eye and face protection The relevant standard is AS/NZS 1337.1:2010+A1:2012+A2:2018, “Personal eye protection—Part 1: eye and face protectors for occupational applications.” The standard is based on (but not identical to) EN 166. The standard specifies requirements for non-prescription oculars (lenses) and assembled eye and face protectors (requirements for prescription eye protectors against low and medium impact are given in another standard of the series, AS/NZS 1337.6). Testing methods are included as appendices in the standard. Table 5.3 shows the requirements for eye and face protection in the Australian market compared to those of the EU and US markets. Table 5.3: Comparison between EU, US, and Australian standards for eye and face protection Notes: For a more detailed comparison of EU and US standards (including test methods), see 4.2.3. • In general, requirements for lenses (only) have not been included. • Only low-impact resistance is included for the AS/NZS. Color code: Green: Products made to the Australian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Australian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Australian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Australia US (Market) EU AS/NZS COMPARISON/ ANSI/ISEA Z87.1-2020 standard EN 166:2001 1337.1:2010+A1+A2 COMMENTS Characteristic/ property Requirement/ Requirement/ Requirement/testing method testing method testing method Construction and Pass, clause 3.2.1 Pass Pass (finish), 3.2.2 Comparable to EU materials (materials) (ANSI Z80.1) Headband Pass n/a n/a Basic/“fundamental”     requirements 62 https://www.safetyandquality.gov.au/covid-19-resources/faqs-community-use-face-masks. 136 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Australia US (Market) EU AS/NZS COMPARISON/ ANSI/ISEA Z87.1-2020 standard EN 166:2001 1337.1:2010+A1+A2 COMMENTS Characteristic/ property Requirement/ Requirement/ Requirement/testing method testing method testing method Pass Called “viewing area” in the Field of vision Pass (EN 168) AS/NZS Min. dimensions given in the standard for Not a requirement, spectacles/goggles/ Ellipse with axes ≥40 mm and ≥ Not directly comparable Min. coverage area except for special face shields 33 mm to US uses Clauses 2.2.3, 2.2.4; (for small heads) 3.2.5. Transmittance of ≥80% (ocular category > 74.4% 0), Similar limits/test method oculars without ≥ 85% (or ≥ 78% if relaxed optics) (EN 167) as in EN filtering action (Annex A) ≤3% ≤3% Called “scattered light” in Haze n/a (Annex H) (ASTM D1003-13) AS/NZS, similar to US Pass (Annex K, drop ball test, Called “low-impact Pass Pass definitive test) resistance” in AS/NZS, (EN 168) similar to EU/US Increased robustness Pass (Annex L (ballistic test; if in doubt, use Annex K) Penetration resistance (for plastic oculars/ n/a n/a Pass, Annex P visors) (projectile test) Pass Pass More stringent testing Thermal stability n/a (EN 168) (Annex T) than in EN Pass Pass resistance to corrosion Pass (EN 168) (Annex U) Same method as in EU Pass Pass Very similar method to Resistance to ignition Pass (EN 168) (Annex Q) EU/US Particular requirements (per     EU) No color present for goggles No color present for goggles Same limit/method as in Droplets and splashes No color present for all the EU (for droplets only) Face shields pass Face shields pass the area of liquid protectors (Annex V) Different method for the area coverage coverage test splashes test (EN 168) Applies only to eye Pass protectors claiming impact Lateral protection Pass (Annex D) resistance greater than (optional) (EN 168) Pass Clause 3.2.6 low impact resistance; similar method to EU/US Optional requirements (per EU) Resistance to fogging In AS/NZS, ventilation Time without (only for oculars; openings only for goggles fogging ≥ 8 s n/a Time without fogging ≥ 8 s not complete eye that are not splash (to EN 168) protectors) resistant 137 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 5.3 Gloves 5.3.1 Medical examination gloves The relevant standard on rubber examination gloves, AS/NZS 4011.1, is a modified ISO 11193-1:2008 (there is now a 2020 version of the ISO standard). Variations are listed in Appendix ZZ of the AS/NZS standard. The same situation applies to AS/NZS 4011.2 on PVC gloves versus ISO 11193-2:2006 (current). The main variations of interest in this guide (common for both standards) are: • Small modifications in the watertightness test • Modifications in the tensile properties limits and methods • Addition of non-mandatory glove cuff rupture resistance test to be used in cases of dispute. In addition to Types 1 and 2 (with the same meaning as in ASTM/ISO standards), in AS/NZS 4011.1 Type 1a is defined for just “synthetic polyisoprene” gloves. For completeness, the standard AS/NZS 2161.10.1:2005, “Protective gloves against dangerous chemicals and micro-organisms—Part 1: Terminology and performance requirements,” is mentioned. This standard is identical to EN 374-1:2003, now superseded by EN ISO 374-1. As mentioned in 4.3.1.1 on EU requirements for medical examination gloves, standards on “protective gloves” (as opposed to “medical gloves”) will not be further detailed. Table 5.4 shows the requirements for medical examination gloves in the Australian market compared to those of the EU and US markets. Table 5.4: Comparison between EU, US, and Australian standards for medical examination gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.1 of this guide. Color code: Green: Products made to the Australian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Australian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Australian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Australia US Material specific ASTM—material specific (Market) EU AS/NZS 4011.1:2014 for D6319 (nitrile) COMPARISON/COMMENTS standard EN 455 series rubber D3578 (rubber) AS/NZS 4011.2:2014 for PVC D5250 (PVC) D6977 (polychloroprene) There are no Australian Characteristic/ Requirement/ Requirement/testing Requirement/testing standards for exam gloves property testing method method method from materials other than rubber or PVC Freedom from AQL =1.5 AQL =2.5 Test method slightly modified AQL =1.5 holes (EN 455-1:2020) (ASTM D5151) from that of the EU/US 138 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Australia US Material specific ASTM—material specific (Market) EU AS/NZS 4011.1:2014 for D6319 (nitrile) COMPARISON/COMMENTS standard EN 455 series rubber D3578 (rubber) AS/NZS 4011.2:2014 for PVC D5250 (PVC) D6977 (polychloroprene) There are no Australian Characteristic/ Requirement/ Requirement/testing Requirement/testing standards for exam gloves property testing method method method from materials other than rubber or PVC In the EU, instead of AQL the AQL = 4.0 Non-thermoplastic median of 13 samples is used materials ≥6.0N Nitrile ≥ 14MPa/elongation In general, the tensile ≥400% AQL = 4.0 properties and their limits specified in the Australian/ISO For rubber, standards are an amalgam of Latex (natural) the EU/US ones Force at break ≥ 6.0 N (N) / ≥ 14MPa/elongation ≥ 500% Elongation ≥ 500% (Types 1 Tensile strength Australian and EU standards and 1a); ≥400% (Type 2) (MPa), elongation Thermoplastic specify minimum absolute at break (%) materials (PVC, Polychloroprene force (N) for samples taken PE) from the glove (varies with (Also, after For PVC ≥ 14MPa/elongation ≥ 400% thickness); ASTM specifies ageing/challenge) ≥ 3.6N in terms of tensile strength ≥ 7.0 N (MPa—force per unit area) Elongation ≥ 350% PVC ≥ 11MPa/elongation ≥ 300% (EN 455-2 :2015, method A of ISO Test method for Australia is 23529:2010) (ASTM D412, ASTM D573 slightly modified from that of (ageing)) the EU/US and ISO 23529 Pass Pass Pass Biocompatibility (EN ISO 10993-5 and -10) (Relevant part(s) of ISO 10993) (FDA regulations) ≤ 2.0 mg/glove (powder-free gloves) Powder residue ≤ 2.0 mg/glove (EN 455-3, EN ISO n/a ≤ 10 mg/dm2 (powdered content 21171:2006) gloves) (ASTM D6124) “Manufacturer shall monitor the ≤ 200 µg/dm2 Aqueous soluble content in natural rubber latex gloves n/a Only for rubber gloves protein content and shall try to minimize it” (EN (ASTM D5712) 455-3) ≤ 10 µg/dm2 Extractable antigenic Optional n/a Only for rubber gloves protein content (ASTM D6499) “If gloves are sterilized, the EN 455-4 refers nature of the sterilization to EN ISO 11607 Pass process shall be disclosed ON Sterility (sterile barrier THE PRODUCT in accordance (US Pharmacopeia) integrity during with appropriate local shelf-life) regulatory requirements” A non-mandatory test (only in Cuff rupture Force ≥5N n/a n/a case of dispute); method given resistance test in Appendix ZA of AS/NZS 4011 Medical examination gloves are regulated as medical devices in Australia, see 3.3.1. 139 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 5.3.2 Surgical gloves The relevant standard, AS/NZS 4179:2014, “Single-use sterile surgical globes-specification,” is a modified version of ISO 10282:2014 (current) with variations contained in Appendix ZZ of AS/NZS 4179. The main variations of interest in this guide are: • Synthetic polyisoprene gloves have been moved from Type 2 (synthetic rubbers) to Type 1a, as their material properties are more closely related to natural rubber latex • Small modifications in the watertightness test • Modifications in the tensile properties limits and methods • Addition of non-mandatory glove cuff rupture resistance test to be used in cases of dispute. Table 5.5 shows the requirements for surgical gloves in the Australian market compared to those of the EU and US markets. Table 5.5: Comparison between EU, US, and Australian standards for surgical gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.2 of this guide. Color code: Green: Products made to the Australian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Australian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Australian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. US EU Australia ASTM D3577-19, (Market) EN 455 series AS/NZS 4179:2014 Type 1: Natural rubber COMPARISON/COMMENTS Standard (Types 1, 1a and 2) Type 2: Synthetic rubber Characteristic/ Requirement/ Requirement/testing Requirement/ Property testing method method testing method AQL = 0.65 AQL = 1.5 Test method slightly different from Freedom from holes AQL = 1.0 (EN 455-1:2020) (ASTM D5151) that of EU/US 140 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US EU Australia ASTM D3577-19, (Market) EN 455 series AS/NZS 4179:2014 Type 1: Natural rubber COMPARISON/COMMENTS Standard (Types 1, 1a and 2) Type 2: Synthetic rubber Characteristic/ Requirement/ Requirement/testing Requirement/ Property testing method method testing method In the EU, instead of AQL the median of 13 samples is used AQL = 4.0 In general, the tensile properties and Types 1, 1a— latex their limits specified in the Australian AQL = 4.0 (natural rubber and standards are an amalgam of the EU/ synthetic polyisoprene) l—latex (natural) US ones Type 1­ ≥18MPa/elongation Force at break (N) / ≥9.5 N/elongation ≥550% ≥560% All materials Tensile strength EU and AS/NZS standards specify ≥ 9.0N minimum absolute force (N) for (MPa), elongation —synthetic rubber Type 2—synthetic Type 2­ samples taken from the glove (varies (%) (EN 455-2 :2015, (except polyisoprene) with thickness); ASTM specifies in rubber ≥12Mpa/ method A of ISO terms of tensile strength (MPa—force (Also, after ageing/ elongation ≥490% 23529:2010) ≥9.0N/elongation per unit area) challenge) ≥500% (ASTM D412, ASTM The AS/NZS values are after accelerated D573 [ageing]) ageing (higher limits apply before ageing) Test method slightly different from that of EU/US Pass “Shall comply with the Pass Biocompatibility (EN ISO 10993-5 and relevant part(s) of ISO 10993” (FDA regulations) -10) ≤ 2.0 mg/glove ≤ 2.0 mg/glove Powder residue (EN 455-3, EN ISO No explicit requirements content (ASTM D6124) 21171:2006) “Manufacturer shall monitor the ≤ 200 µg/dm2 Aqueous soluble content in NRL n/a (ASTM D5712) protein content gloves and shall try to minimize it” (EN 455-3, Annex A) Extractable ≤ 10 µg/dm2 Optional antigenic protein n/a content (EN 455-3, Annex B) (ASTM D6499) EN 455-4 refers to Sterilized in accordance Pass EN ISO 11607 (sterile with ISO 11135 (ethylene Sterility (US Pharmacopeia) barrier integrity oxide) or ISO 11137 during shelf-life) (radiation) Non-mandatory test (only in case of Cuff rupture dispute); n/a Force ≥5N n/a resistance test method given in Appendix ZA of AS/ NZS 4179 Surgical gloves are regulated as medical devices in Australia, see 3.3.1. 141 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 5.4 Clothing 5.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) The only relevant standard identified in Australia is AS/NZS 4501.2:2006, “Occupational protective clothing—Part 2: General requirements,” an identical adoption of EN 340:2003 (since replaced by EN ISO 13688:2013+A1:2021) that addresses only general requirements for protective clothing. This standard does not address either chemical protection or protection against infective agents. Table 5.6 shows the requirements for protective clothing in the Australian market compared to those of the EU and US markets. Table 5.6: Comparison between EU, US, and Australian standards for protective clothing Notes: For a more detailed comparison of EU and US standards (including test methods), see 4.4.1 of this guide. For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components, such as visors, are not included). For protection against infective agents only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection­—Type 4), Type 6 (limited —Type 6). protection against liquid chemicals) and Type PB [6] (partial-body protection­ Color code: Green: Products made to the Australian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Australian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Australian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Market EU Australia US COMPARISON/COMMENTS Characteristic/ Requirement/testing Requirement/ Requirement/testing property method testing method method The AS/NZS only specifies general requirements about (any type of) protective clothing and it supplements standards with requirements for specific I. General EN ISO protection. AS/NZS 4501.2:2006 NFPA 1999:2018 requirements 13688:2013+A1:2021 No AS could be identified similar to EN 14126 (protection against infective agents) but EN 14126 seems to be accepted in Australia, as well No harmful substances AS/NZS is similar to EN ISO 13688 No harmful present (contains fewer requirements than Innocuousness substances present No specific requirements it, and some methods have since No azo dyes present No azo dyes present been revised) 142 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Australia US COMPARISON/COMMENTS Characteristic/ Requirement/testing Requirement/ Requirement/testing property method testing method method Acceptable (section 6.1) Note: Design requirements only ≥650 g/(m224 h) Note: In the US for single-use garments/ Acceptable ensembles “moisture Acceptable; vapor transmission rate” Design and comfort (Annex C) assessment in Annex Similar to EN ISO 13688 is specified (section 8.28 C and ASTM E96) ≥450 W/m2 Note: In the US for multiple-use garments/ ensembles “total heat loss test” is specified (section 8.32 and ASTM F1868) EN 14126:2003 & EN 14605:2005+A1:2009 II. Protection (for Types 4 and No requirements in NFPA 1999:2018 against infective PB [4]) or EN AS/NZS 13034:2005+A1:2009 agents (for Types 6 and PB [6]) 1. Materials requirements No requirements a) Mechanical for mechanical properties Abrasion resistance Class 1 to 6 (highest) is considered as a precondition to barrier Abrasion resistance (cl. 4.4 of EN 14325 & EN n/a performance of materials ISO 12947-2) (ASTM D4157) Flex fatigue is considered Class 1 to 6 (highest) as a precondition to Flex cracking barrier performance of (cl. 4.5, 4.6 EN 14325 and n/a resistance materials EN ISO 7854, method B) (ASTM F392) Single-use: “Tear- resistance test two” ≥17 N (section 8.38 and ASTM Class 1 to 6 (highest) D5733 for non-woven) Trapezoidal tear (EN 14325 & EN ISO n/a resistance Multiple-use: “Tear- 9073-4:1997) resistance test one” ≥36 N (section 8.7 and ASTM D5587 for woven) ≥50 N (section 8.4 and ASTM D5034) Class 1 to 6 (highest) Bursting strength was eliminated Tensile strength (cl. 4.9 of EN 14325 & EN n/a Also bursting strength: ≥66N (single-use) in EU ISO 13934-1) ≥222.5N (multiple-use) (section 8.5 and ASTM D3787) ≥12N (single-use) Class 1 to 6 (highest) ≥25N (multiple-use) Puncture resistance (cl. 4.10 of EN 14325 & n/a EN 863) (section 8.6 and ASTM D2572) 143 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Australia US COMPARISON/COMMENTS Characteristic/ Requirement/testing Requirement/ Requirement/testing property method testing method method No requirements for b) Chemical chemical resistance resistance properties Permeation by Class 1 to 6 (highest) chemicals (EN ISO 6529, method A n/a for liquids) (applicable to Types 4 and PB[4]) Repellency to liquids In the US this is called “water- Class 1 to 3 (highest) ≤30% absorption resistance test”; applies n/a (section 8.31) (applicable to Types (ISO 6530) only to multiple-use garments/ 6 and PB[6]) ensembles Penetration by liquids Class 1 to 3 (highest) n/a (applicable to Types (ISO 6530) 6 and PB[6]) No requirements for c) flammability flammability Resistance to Pass or Min. class 1 (cl. Flame spread time ≥3.5 s ignition or flame 4.14 EN 14325 and EN n/a (section 8.39 and ASTM (more stringent) 13274-4, method 3) D1230) d) Penetration by No requirements for infective agents infective agents Pass Class 1 to 6 (highest) Contaminated Note: In the US the “bio- (cl. 4.1.4.1 of EN 14126, penetration test one” liquids under n/a ISO 16603 and ISO applies hydrostatic pressure (section 8.3 and ASTM 16604) F1671) Mechanical contact Class 1 to 6 (highest) with contaminated (cl. 4.1.4.2 of EN 14126 n/a n/a liquids (wet bacterial and EN ISO 22610) penetration) (Biologically) Class 1 to 3 (highest) contaminated liquid n/a n/a (cl. 4.1.4.3 of EN 14126) aerosols Contaminated As above solid particles (cl. 4.1.4.4 of EN 14126 n/a n/a (dry microbial and ISO 22612) penetration) 2. Whole-suit No requirements for requirements whole suits Pass Pass (section 8.2) (EN ISO 17491-4 (method Mist test (Type 6) n/a Note: In the US the “liquid A) as modified by cl. 5.2 tight integrity test one” of EN 13034) applies Pass Liquid spray test Pass (cl. 4.3.4.2 etc. of EN n/a (section 8.2) (Type 4) 14605 and EN ISO 17491- 4 [method B]) Pass Demonstration of (EN 14605/EN garment functionality is Practical included as part of the 13034—”seven n/a performance liquid integrity testing movements” sequence applied to garments while wearing the suit) (ASTM F1154) 144 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 5.4.2 Gowns On the Standards Australia website, there is a reference to standards relating to key PPE for medical applications and environments. These are listed at https://www.standards.org.au/getmedia/4d7449e3- ee13-4b54-8f01-4347638010e6/D_1588-Standards-and-COVID-19-(002).aspx The standard mentioned for gowns is AS 3789.2–1991, “Textiles for health care facilities and institutions— theatre linen and pre-packs.” In the standard, among others, requirements are specified for “(operating) theatre gowns”. However, these pertain only to dimensions, fabric types and so on, and not to barrier or mechanical properties. On the Therapeutic Goods Administration (TGA) website, on the other hand, no specific Australian standard is mentioned for gowns, while reference is made to the standards in the EU and the United States, which are accepted for regulatory purposes, see https://www.tga.gov.au/behind-news/regulation-personal- protective-equipment-and-covid-19 As a result, no comparison to the EU-US standards can be provided. 145 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 6 PRODUCT-SPECIFIC COMPARISONS (BRAZIL) 6.1 Masks 6.1.1 Respirators The Brazilian standard ABNT NBR 13698:2011 is based on EN 149:1992 (which has since been substantially revised in a new 2001 edition and an amendment in 2009). Respirator classes PFF2 and PFF3, corresponding to FFP2 and FFP3 in the European standard, are considered in this guide. Table 6.1 shows the requirements for respirators in the Brazilian market compared to those of the EU and US markets. Table 6.1: Comparison between EU, US, and Brazilian standards for respirators Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 of this guide. Color code: Green: Products made to the Brazilian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Brazilian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Brazilian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. EU EN 149:2001 Brazil US (Market) +A1:2009, ABNT NBR 13698:2011, 42 CFR Part 84, Series/Levels standard COMPARISON/COMMENTS Classes FFP2 and Classes PFF2 and PFF3 N95 and N99 FFP3 Note that other classes of Characteristic/ Requirement/testing Requirement/testing Requirement/testing respirators are not included— property method method method not suitable for COVID-19 context Pass (based on two Pass (based on two Fit testing before use Practical subjects performing subjects performing (required by OSHA, not performance various tasks) various tasks) NIOSH) FFP2 PFF2 ≤ 11% (individual) ≤ 11% (individual) n/a Total inward ≤ 8% (mean) ≤ 8% (mean) leakage FFP3 PFF3 ≤ 5% (individual) ≤ 5% (individual) n/a ≤ 2 % (mean) ≤ 2 % (mean) 146 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets EU EN 149:2001 Brazil US (Market) +A1:2009, ABNT NBR 13698:2011, 42 CFR Part 84, Series/Levels standard COMPARISON/COMMENTS Classes FFP2 and Classes PFF2 and PFF3 N95 and N99 FFP3 Note that other classes of Characteristic/ Requirement/testing Requirement/testing Requirement/testing respirators are not included— property method method method not suitable for COVID-19 context Specified as 6% max. FFP2 PFF2 N95 penetration in Brazilian and ≥ 94% @ 95 L/min ≥ 94% @ 95 L/min (NaCl ≥ 95% EU standards; limits in Brazil (NaCl and paraffin oil, and paraffin oil) @ 85 L/min (NaCl only) and EU are same, but method (EN 13274-7) Filtering differs efficiency Specified as 1% max. FFP3 N99 PFF3 penetration in Brazilian and ≥ 99% @ 95 L/min ≥ 99% ≥ 99% @ 95 L/min EU standards; limits in Brazil (NaCl and paraffin oil, @ 85 L/min (NaCl and paraffin oil) and EU are same, but method EN 13274-7) (NaCl only) differs Compatibility with Pass Pass n/a skin Flammability Pass Pass n/a Carbon dioxide Average ≤ 1% by volume Average ≤ 1% by volume n/a content in “dead space” in “dead space” Pass (in the practical Pass (in the practical Field of vision Pass performance test) performance test) FFP2 PFF 2 N95 ≤ 70 Pa @ 30 L/min ≤ 70 Pa @ 30 L/min Breathing ≤ 343 Pa @ 85 L/min ≤ 240 Pa @ 95 L/min ≤ 240 Pa @ 95 L/min resistance FFP 3 PFF 3 (inhalation) N99 ≤ 100 Pa @ 30 L/min ≤ 100 Pa @ 30 L/min ≤ 343 Pa @ 85 L/min ≤ 300 Pa @ 95 L/min ≤ 300 Pa @ 95 L/min Breathing FFP2 and FFP3 PFF 2 and PFF 3 N95 and N99 resistance ≤ 300 Pa @160 L/min ≤ 300 Pa @160 L/min ≤ 245 Pa @ 85 L/min (exhalation) 147 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 6.1.2 Medical face masks The relevant standard, NBR 15052:2004, is the version referred to by the regulator, the Brazilian Health Regulatory Agency (ANVISA), and is based on the Australian Standard AS 4381:2015 (see 5.1.2). It defines Levels 1, 2 and 3, approximately corresponding to the same levels of barrier protection in the US (standard ASTM F2100). A newer version (NBR 15052:2021) was published in August 2021. Table 6.2 shows the requirements for medical face masks in the Brazilian market compared to those of the EU and US markets. Table 6.2: Comparison between EU, US, and Brazilian standards for medical face masks Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.2 of this guide. Color code: Green: Products made to the Brazilian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Brazilian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Brazilian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. EU Brazil US (Market) EN 14683:2019, NBR 15052:2004, ASTM F2100–21, COMPARISON/COMMENTS standard Types I, II and IIR Levels 1, 2 and 3 Levels 1, 2 and 3 This table is based on NBR 15052:2004, Characteristic/ Requirement/testing Requirement/ Requirement/ and changes introduced in the new property method testing method testing method (2021) version have been noted ≥ 95% (Levels 0 and 1) Essentially the same (for corresponding ≥ 95% (Type I) ≥ 98% (Levels 2 and 3) ≥ 95% (Levels 1) Bacterial filtration types) ≥ 98% (Types II, IIR) Using ASTM F2101-14 or ≥ 98% (Levels 2,3) efficiency (BFE) (NBR 15052:2021 now refers to Appendix B of EN Using ASTM F2101 EN14683:2019) 14683:2014 Brazilian standards are same or stricter than EU/US equivalents for different <39.2 Pa/cm2 (Level categories 1) < 40 Pa/cm2 (Types <49.0 Pa/cm2 (Levels 2 <49 Pa/cm2 Brazilian standards are same or stricter I, II) and 3) (Level 1) than EU/US equivalents for different categories Differential pressure < 60 Pa/cm (Type 2 (Specified as 4.0 mm IIR) <58.8 Pa/cm2 (Levels and 5.0 mm H2O/cm 2 2 and 3) The 2021 version of NBR 15502 has (Tested at 8L/min respectively) Using EN 14683 relaxed the requirements for differential flowrate) pressure, now aligned with ASTM Using EN 14683:2014, F2100. This will mean that masks Appendix C made to NBR 15052:2021 will not automatically meet the requirement of the EU market ≥ 95 (Level 1) The 2021 version of NBR 15052 now Sub-micron particulate filtration includes identical requirements to efficiency n/a n/a ≥ 98 (Levels 2,3) those of ASTM F2100, so the color code will change to green once this is fully Both at 0.1 micron, adopted using ASTM F2299 148 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets EU Brazil US (Market) EN 14683:2019, NBR 15052:2004, ASTM F2100–21, COMPARISON/COMMENTS standard Types I, II and IIR Levels 1, 2 and 3 Levels 1, 2 and 3 This table is based on NBR 15052:2004, Characteristic/ Requirement/testing Requirement/ Requirement/ and changes introduced in the new property method testing method testing method (2021) version have been noted ≥ 10.7 kPa (Level 1) ≥ 10.7 kPa (Level 1) Brazilian requirements identical to Not required (Types ≥16 kPa (Level 2) ≥16 kPa (Level 2) ASTM I, II) Splash-resistance Note 2: Specified as ≥ 80, ≥120 and ≥160 ≥21.4 kPa (Level 3) ≥21.4 kPa (Level 3) pressure mm Hg respectively ≥ 16.0 kPa (Type IIR) Note 2 Using ISO 22609:2004 Using ASTM F1862 Using ASTM F1862 Microbial ≤ 30 CFU/g No explicit n/a cleanliness requirement Using EN ISO 11737-1:2018 Mentioned in NBR Pass 15052 and required by Pass Biocompatibility Using ISO EN 10993- ANVISA regulations Using ISO 10993-1 1:2009 (Using ISO EN 10993- 1:2009) The 2021 version of NBR 15052 now specifies requirements identical to Class 1 those of ASTM F2100 (Class 1 using Flame spread n/a n/a Using 16 CFR Part 16CFR Part 1610), so the color code 1610 will change to green once this is fully adopted 149 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 6.1.3 Community face coverings ABNT PR 002:2020, “Masks for non-professional respiratory protection—guide with basic requirements for testing, manufacture, and use,” is based on AFNOR SPEC S76-001. Table 6.3 shows the requirements for community face coverings in the Brazilian market compared to those of the EU and US markets. Table 6.3: Comparison between EU, US, and Brazilian standards for community face coverings Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.3 of this guide. Color code: Green: Products made to the Brazilian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Brazilian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Brazilian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. (Market) EU Brazil US standard CWA 17553:2020 ABNT recommended practice COMPARISON/COMMENTS ASTM F3502-21 PR 002:2020 Characteristic/ Requirement/ Requirement/testing Requirement/testing method property testing method method EN 14683:2019, Annex C Subpart K of 42 CFR Part (≤ 70 Pa/cm2) 84, modified by § 8.2 Breathing In the EU, either breathing Inhalation resistance of 2.4 (Level 1 ≤ 15 mm H2O resistance EN 13274-3 resistance or air permeability mbar; exhalation resistance of (inhalation Level 2 ≤ 5 mm H2O) (below) is measured 3 mbar (breathing machine at resistance of 2.4 a sinusoidal flow of 30 l/min or mbar; exhalation constant flow of 160 l/min) resistance 3 mbar) EN ISO 9237 Air permeability (≥ 96 l/s/m2 n/a n/a @ 100 Pa) EN 13274-7 EN ISO 16890-2 Subpart K of 42 CFR Part Particle 84, modified by § 8.1 filtration ≥ 70%—particle size 3 (± 0.5) μm In the EU, either PFE or BFE EN ISO 21083-1:2018, efficiency (PFE) EN 13274-7 (Level 1 ≥20%; Level 2 ≥ (below) is measured (Level 90% ≥ 90%; 50%) Level 70% ≥ 70%) Particle size 3 (± 0.5) μm EN Bacterial Manufacturer may choose 14683:2019+AC:2019 filtration to provide the BFE results efficiency (BFE) (Level 90% ≥ 90%; n/a (as per ASTM F 2101) along with PFE Level 70% ≥ 70%) 150 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 6.2 Eye and face protection There is no Brazilian national standard for eye and face protection—Brazilian PPE regulations refer to the “latest version of ANSI Z87.1.” The recently published recommended practice for health care-related face protection (ABNT PR1009:2021) also draws heavily on ANSI/ISEA Z87.1, but is not referred to in the Brazilian PPE regulations. Table 6.4 shows the requirements for eye and face protection in the Brazilian market compared to those of the EU and US markets. Table 6.4: Comparison between EU, US, and Brazilian standards for eye and face protection Notes: • In general, requirements for lenses (only) have not been included. • For a more detailed comparison of EU and US standards (including test methods), see 4.2 of this guide. Color code: Green: Products made to the Brazilian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Brazilian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Brazilian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. (Market) Brazil EU US standard ABNT PR1009:2021 COMPARISON/COMMENTS EN 166:2001 ANSI/ISEA Z87.1:2020 Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method Construction and Pass Pass Pass materials (ANSI Z80.1) (ANSI Z80.1) Headband Pass n/a n/a Basic (EU)/ fundamental (US)       requirements Pass Field of vision n/a n/a (EN 168) Ellipse with axes ≥40 mm and Ellipse with axes ≥40 Min. coverage area n/a ≥ 33 mm mm and ≥ 33 mm Transmittance of > 74.4% ≥ 85% (or ≥ 78% if relaxed ≥ 85% (or ≥ 78% if relaxed oculars without (EN 167) optics) optics) filtering action ≤3% ≤3% Haze n/a (ASTM D1003-13) (ASTM D1003-13) Pass Increased robustness Pass Pass (EN 168) Pass Thermal stability n/a n/a (EN 168) Resistance to Pass Pass Pass corrosion (EN 168) Pass Resistance to ignition Pass Pass (EN 168) “Particular requirements” (per       EU) 151 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets (Market) Brazil EU US standard ABNT PR1009:2021 COMPARISON/COMMENTS EN 166:2001 ANSI/ISEA Z87.1:2020 Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method No color present for No color present for goggles No color present for goggles goggles Droplets and splashes of liquid Face shields Face shields pass the area Face shields pass the pass the area coverage test area coverage test coverage test (EN 168) Lateral protection Pass Pass Pass Only for impact-rated protectors in (optional) (EN 168) (Annex D) (Annex D) US/Brazil Resistance to fogging Time without fogging Time without Time without fogging Requirement did not exist in 2015 (only for oculars; ≥8s fogging ≥ 8 s ≥8s edition of US standard; added in not complete eye (EN 168) 2020 edition protectors) 6.3 Gloves 6.3.1 Medical examination gloves Medical examination gloves are regulated as medical devices in Brazil (see 3.4.1). Brazilian standards are material specific. NBR ISO 11193-1:2015 (for gloves made of rubber/ latex) and NBR ISO 11193-2:2013 (made of PVC) are identical to ISO 11193-1:2008 + AMD 1:2012 (recently replaced by the 2020 edition) and ISO 11193- 2:2006 (current), respectively. For details on the ISO standards, see 4.3.1.1. Table 6.5 shows the requirements for medical examination gloves in the Brazilian market compared to those of the EU and US markets. Table 6.5: Comparison between EU, US, and Brazilian standards for medical examination gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.1.3 of this guide. Color code: Green: Products made to the Brazilian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Brazilian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Brazilian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Brazil US Material specific ASTM­— EU NBR ISO 11193-1:2015 material specific (Market) EN 455 series (rubber/ latex) D6319 (nitrile) COMPARISON/COMMENTS standard NBR ISO 11193-2:2013 D3578 (rubber) (PVC) D5250 (PVC) D6977 (polychloroprene) INMETRO PORTARIA N° 485 (2021) also applies; conformity assessment Characteristic/ Requirement/ Requirement/ Requirement/testing requirements are also specified in property testing method testing method method PORTARIA No. 672 of November 8, 2021 Freedom from AQL =1.5 AQL =2.5 AQL =1.5 holes (EN 455-1:2020) (ASTM D5151) 152 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Brazil US Material specific ASTM­— EU NBR ISO 11193-1:2015 material specific (Market) EN 455 series (rubber/ latex) D6319 (nitrile) COMPARISON/COMMENTS standard NBR ISO 11193-2:2013 D3578 (rubber) (PVC) D5250 (PVC) D6977 (polychloroprene) INMETRO PORTARIA N° 485 (2021) also applies; conformity assessment Characteristic/ Requirement/ Requirement/ Requirement/testing requirements are also specified in property testing method testing method method PORTARIA No. 672 of November 8, 2021 Non-thermoplastic materials AQL = 4.0 ≥6.0N AQL = 4.0 Nitrile ≥ 14MPa/elongation In the EU, instead of AQL the median of 13 samples is used (Before ageing) ≥400% Force at break Rubber ≥ 7.0 N (Types Latex (natural) (N) / 1 and 2)/elongation ≥ In general, the tensile properties and 650% (Type 1), 500% ≥ 14MPa / their limits specified in the Brazilian Tensile strength (Type 2) Elongation ≥ 500% standards are an amalgam of the EU/ (MPa), elongation US ones at break (%) (After ageing) Thermoplastic Polychloroprene Brazilian and EU standards specify materials (PVC, PE) Rubber ≥ 6.0 N (Types (Also, after ≥ 14MPa/elongation ≥ 400% minimum absolute force (N) for 1 and 2)/elongation ≥ samples taken from the glove (varies ≥ 3.6N ageing/challenge) 500% Type 1), 400% with thickness); ASTM specifies in (Type 2) PVC ≥ 11MPa/elongation ≥ terms of tensile strength (MPa—force 300% per unit area) PVC ≥ 7.0 N/elongation (EN 455-2 :2015, ≥ 350% (ASTM D412, ASTM D573 method A of ISO (ageing)) 23529:2010) Pass Pass; gloves should be previously evaluated as Biocompatibility (EN ISO 10993-5 and Pass (FDA regulations) safe for use in contact -10) with human skin ≤ 2.0mg/glove (powder-free gloves) ≤ 2.0mg/glove Powder residue (EN 455-3, EN ISO n/a ≤ 10 mg/dm2 (powdered content 21171:2006) gloves) (ASTM D6124) Gloves containing ≤ 200 µg/dm2 “Manufacturer shall natural rubber latex Aqueous soluble monitor the content must be subjected Only for rubber gloves in natural rubber latex to operations and protein content gloves and shall try to processing that ensure (ASTM D5712) minimize it” (EN 455-3) the reduction of protein content ≤ 10 µg/dm2 Extractable antigenic protein Optional n/a Only for rubber gloves content (ASTM D6499) Mandatory to indicate the type of sterilization EN 455-4 refers to on the packaging; Pass EN ISO 11607 (sterile gloves should be Sterility (US Pharmacopeia) barrier integrity tested according to the during shelf-life) methodology described in Annex C of Portaria N° 485 (2021) 153 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 6.3.2 Surgical gloves Surgical gloves are regulated as medical devices in Brazil (see 3.4.1). The Brazilian standard ABNT NBR 10282:2014 is identical to ISO 10282:2014. For further details on ISO 10282 see 4.3.2.1. Table 6.6 shows the requirements for surgical gloves in the Brazilian market compared to those of the EU and US markets. Table 6.6: Comparison between EU, US, and Brazilian standards for surgical gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.2.3 of this guide. Color code: Green: Products made to the Brazilian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Brazilian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Brazilian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. US COMPARISON/COMMENTS EU Brazil (Market) ASTM D3577-19 EN 455 series ABNT NBR 10282:2015 standard Type 1: Natural rubber INMETRO PORTARIA N° 485 Type 2: Synthetic rubber (2021) also applies Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method AQL = 0.65 AQL = 1.5 Freedom from holes AQL = 0.65 (EN 455-1:2020) (ASTM D5151) AQL = 4.0 (Before ageing) In the EU, instead of AQL the Type 1: Latex (natural) median of 13 samples is used AQL = 4.0 ≥12.5 N/elongation In general, the tensile ≥700%/force at 300% Type 1: Latex (natural) ≤ 2N properties and their limits ≥18MPa/elongation ≥560% specified in the Brazilian Force at break (N) / All materials standards are an amalgam Type 2: Synthetic Tensile strength rubber ≥9.0N/ of the EU/US ones ≥ 9.0N (MPa), elongation (%) elongation ≥600%/ Type 2: Synthetic rubber force at 300% ≤ 3N EU and Brazilian standards (EN 455-2:2015, method ≥12Mpa/elongation ≥490% (Also, after ageing/ specify minimum absolute A of ISO 23529:2010) (After ageing) challenge) force (N) for samples taken from the glove (varies with Type 1: Latex (natural) thickness); ASTM standards ≥9.5 N/elongation (ASTM D412, ASTM D573 [ageing]) specify in terms of tensile ≥550% strength (MPa—force per Type: Synthetic rubber unit area) ≥9.0N/elongation ≥500% Pass; gloves should be Pass previously evaluated as Pass Biocompatibility (EN ISO 10993-5 and -10) safe for use in contact (FDA regulations) with human skin ≤ 2.0 mg/glove ≤ 2.0mg/glove Powder residue (EN 455-3, EN ISO n/a content (ASTM D6124) 21171:2006) Gloves containing “Manufacturer shall natural rubber latex ≤ 200 µg/dm2 Aqueous soluble monitor the content in must be subjected NRL gloves and shall try to operations and (ASTM D5712) protein content to minimize it” (EN 455-3, processing that ensure Annex A) the reduction of protein content 154 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US COMPARISON/COMMENTS EU Brazil (Market) ASTM D3577-19 EN 455 series ABNT NBR 10282:2015 standard Type 1: Natural rubber INMETRO PORTARIA N° 485 Type 2: Synthetic rubber (2021) also applies Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method ≤ 10 µg/dm2 Extractable antigenic Optional n/a protein content (EN 455-3, Annex B) (ASTM D6499) Mandatory to indicate the type of sterilization EN 455-4 refers to EN on the packaging; Pass ISO 11607 (sterile barrier gloves should be Sterility (US Pharmacopeia) integrity during shelf- tested according to the life) methodology described in Annex C of Portaria N° 485 (2021) 6.4 Clothing 6.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) The currently applicable standard is the nationally developed Brazilian standard ABNT NBR 16693:2018, “Textile products for health—non-surgical gowns and private clothing used for non-surgical procedure —requirements and test methods.” This is currently undergoing revision and will professionals and patients­ be replaced by a new standard to be based on ANSI/AAMI PB70. Table 6.7 shows the requirements for protective clothing in the Brazilian market compared to those of the EU and US markets. It should be noted that NBR 16693 makes a distinction between the requirements for garments to be used by health care professionals and those for patients in a non-surgical setting. The comparisons shown relate only to the requirements for health care professionals. 155 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 6.7: Comparison between EU, US, and Brazilian standards for protective clothing Notes: For a more detailed comparison of EU and US standards (including test methods), see 4.4.1 of this guide. For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components, such as visors, are not included) For protection against infective agents only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection—Type 4), Type 6 (limited protection against liquid chemicals) and Type PB [6] (partial-body protection—Type 6) Color code: Green: Products made to the Brazilian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Brazilian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Brazilian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Market EU Brazil US COMPARISON/ Requirement/testing Requirement/testing Requirement/testing COMMENTS Property method method method I. General EN ISO ABNT NBR 16693 is ABNT NBR 16693:2018 NFPA 1999:2018 requirements 13688:2013+A1:2021 currently under revision No harmful substances present Innocuousness n/a no specific requirements No azo dyes present Acceptable (section 6.1) Note: Design requirements only ≥650 g/(m224 h) Note: In the US for single-use garments/ Acceptable Not mentioned in NBR ensembles “moisture Design and vapor transmission rate” is (Annex C) 16693, but required by comfort specified ANVISA regulations (section 8.28 and ASTM E96) ≥450 W/m2 Note: In the US for multiple- use garments/ensembles “total heat loss test” is specified (section 8.32 and ASTM F1868) EN 14126:2003 & EN II. Protection 14605:2005+A1:2009 (for Types 4 and PB [4]) or EN ABNT NBR 16693:2018 NFPA 1999:2018 against infective 13034:2005+A1:2009 (for agents Types 6 and PB [6]) 1. Materials requirements a) Mechanical 156 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Brazil US COMPARISON/ Requirement/testing Requirement/testing Requirement/testing COMMENTS Property method method method Abrasion resistance Class 1 to 6 (highest) is considered as a precondition to barrier Abrasion resistance (cl. 4.4 of EN 14325 and EN n/a performance of materials ISO 12947-2) (ASTM D4157) Class 1 to 6 (highest) Flex fatigue is considered Flex cracking as a precondition to barrier (cl. 4.5, 4.6 EN 14325 and EN n/a resistance performance of materials ISO 7854, method B) (ASTM F392) Single-use: “Tear resistance-test two” ≥17 N (section 8.38 and ASTM Class 1 to 6 (highest) ≥10 N Trapezoidal tear D5733 for non-woven) (ABNT NBR 13351 for non- (EN 14325 & EN ISO 9073- resistance woven; ASTM D 1424 for 4:1997) Multiple-use: “Tear- woven) resistance test one” ≥36 N (section 8.7 & ASTM D5587 for woven) ≥50 N (section 8.4 and ASTM ≥20 N D5034) Class 1 to 6 (highest) (ABNT NBR 13041 for non- Tensile strength (cl. 4.9 of EN 14325 and EN woven; ABNT NBR 14727 or Also bursting strength: ISO 13934-1) ABNT NBR ISO 13934-1 for ≥66N (single-use) woven) ≥222.5N (multiple-use) (section 8.5 and ASTM D3787) ≥12N (single-use) Class 1 to 6 (highest) ≥25N (multiple-use) Puncture resistance (cl. 4.10 of EN 14325 and EN n/a 863) (section 8.6 and ASTM D2572) b) Chemical resistance Permeation by Class 1 to 6 (highest) chemicals (EN ISO 6529, method A for n/a n/a (applicable to Types liquids) 4 and PB [4]) Repellency to liquids ≤30% Class 1 to 3 (highest) n/a (section 8.31) (applicable to Types (ISO 6530) 6 and PB [6]) Penetration by ≥ 100 cm H2O liquids Class 1 to 3 (highest) (EN 20811) n/a (applicable to Types (ISO 6530) 6 and PB[6]) c) Flammability Resistance to Pass or min. Class 1 (cl. 4.14 Flame spread time≥3.5 s ignition or flame EN 14325 and EN 13274-4, n/a (section 8.39 and ASTM (more stringent) method 3) D1230) d) Penetration by infective agents Pass Contaminated Class 1 to 6 (highest) BFE ≥ 99% Note: In the US the “bio- liquids under (ABNT NBR 14873 for non- penetration test one” (cl. 4.1.4.1 of EN 14126, ISO hydrostatic woven and ASTM F2101 for applies 16603 and ISO 16604) woven) (section 8.3 and ASTM pressure F1671) 157 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Brazil US COMPARISON/ Requirement/testing Requirement/testing Requirement/testing COMMENTS Property method method method Mechanical contact with contaminated Class 1 to 6 (highest ) liquids (wet (cl. 4.1.4.2 of EN 14126 and EN n/a n/a bacterial ISO 22610) penetration) (Biologically) Class 1 to 3 (highest) contaminated n/a n/a (cl. 4.1.4.3 of EN 14126) liquid aerosols Contaminated As above solid particles (cl. 4.1.4.4 of EN 14126 and n/a n/a (dry microbial ISO 22612) penetration) 2. Whole-suit requirements Pass Pass (EN ISO 17491-4 (method A) (Section 8.2) Mist test (Type 6) n/a Note: In the US the “liquid as modified by cl. 5.2 of EN tight integrity test one” 13034) applies Pass Liquid spray test (cl. 4.3.4.2 etc. of EN 14605 Pass n/a (section 8.2) (Type 4) and EN ISO 17491-4 [method B]) Demonstration of garment Pass functionality is included Practical (EN 14605/EN 13034—”seven Not mentioned in NBR as part of the liquid 16693, but required by performance movements” sequence while integrity testing applied to ANVISA regulations garments wearing the suit) (ASTM F1154) 158 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 6.4.2 Gowns ABNT NBR 16064:2021, “Textiles for health—surgical drapes and gowns—requirements and test methods,” is based on EN 13795-1:2019. It covers single-use and reusable gowns as well as drapes that are used as medical devices for patients, staff, and equipment, and also provides performance requirements and guidelines to users and buyers. The standard includes a recommendation for manufacturers to operate a quality management system meeting the requirements of ISO 13485. Table 6.8 shows the requirements for gowns in the Brazilian market compared to those of the EU and US markets. Table 6.8: Comparison between EU, US, and Brazilian standards for gowns Note: For a more detailed comparison of EU and US standards (including test methods), see 4.4.2.3 of this guide. Color code: Green: Products made to the Brazilian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Brazilian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Brazilian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. US Brazil EU ANSI/AAMI PB70:2012, (Market) COMPARISON/ EN 13795-1:2019 ASTM F2407-20 (surgical standard ABNT NBR 16064:2021 COMMENTS Surgical gowns gowns) and ASTM F3352-19 Surgical gowns (isolation gowns) Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method Resistance to ≤ 300 CFU (less critical ≤ 300 CFU (less critical areas) areas) dry microbial n/a penetration (EN ISO 22612:2005) (ISO 22612) IB ≥ 2.8 (critical areas, IB ≥ 2.8 (critical areas, standard performance) standard performance) Resistance to wet bacterial IB = 6.0 (critical areas, high IB = 6.0 (critical areas, high n/a penetration performance) performance) (EN ISO 22610:2006) (ISO 22610) Pass (AQL 4%, RQL=20%) Viral/blood n/a n/a (AAMI Level 4) penetration (ASTM F1671) Cleanliness ≤ 300 CFU/100 cm2 ≤ 300 CFU/100 cm2 n/a microbial/bioburden (EN ISO 11737-1:2018) (ISO 11737-1) Log10 (lint count) ≤ 4.0 Log10 (lint count) ≤ 4.0 Particle release Optional (EN ISO 9073-10:2004) (ISO 9073-10) 159 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US Brazil EU ANSI/AAMI PB70:2012, (Market) COMPARISON/ EN 13795-1:2019 ASTM F2407-20 (surgical standard ABNT NBR 16064:2021 COMMENTS Surgical gowns gowns) and ASTM F3352-19 Surgical gowns (isolation gowns) Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method ≥ 20 cm H2O ≥ 20 cm H2O (critical areas, standard (critical areas, standard ≥ 20 cm H2O performance) performance) (AAMI Level 2) ≥ 100 cm H2O ≥ 100 cm H2O Water resistance ≥ 50 cm H2O (hydrostatic (critical areas, high (critical areas, high pressure) performance) performance) (AAMI Level 3) ≥ 10 cm H2O ≥ 10 cm H2O (AQL 4%, RQL=20%) (AATC 127) (Less critical areas) (Less critical areas) (EN ISO 811:2018) (ISO 811) ≤ 4.5 g (AAMI Level 1) Water resistance ≤ 1.0 g (AAMI Levels 2 and 3) n/a n/a (impact penetration) (AQL 4%, RQL=20%) (AATC 42 or NWSP 80.3) ≥ 40 kPa ≥ 40 kPa Bursting strength (dry) ≥ 40 kPa (critical areas) ≥ 40 kPa (critical areas) n/a (wet) (EN ISO 13938:1:1999) (ISO 13938:1) ≥ 20 N ≥ 20 N Tensile strength (dry) ≥ 30 N ≥ 20 N (critical areas) ≥ 20 N (critical areas) (ASTM D 5034) (EN 29073-3:1992) (EN 29073-3) (wet) Pass Pass Pass and report results Biocompatibility (ANSI/ AAMI BE78 or ISO (EN ISO 10993-1:2009) (ISO 10993-1) 10993-10) Packaging for terminally Packaging for sterilized Assurance level of sterilized medical devices Sterility gowns required to meet sterilization process: at least is recommended according 10-6 ISO 11607 series to EN ISO 11607 series Manufacturer to provide Manufacturer to provide Class 1 Flammability fire risk information fire risk information (16 CFR 1610) Optional: Comfort (depends on - Water vapor transmission Comfort (depends on a a variety of properties Other criteria to variety of properties) including thermophysical Rate (ASTM D6701) consider and ergonomic factors) - Evaporative resistance (ASTM F1868, Part B) - etc. 160 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 7 PRODUCT-SPECIFIC COMPARISONS (CANADA) 7.1 Masks 7.1.1 Respirators No comparison is provided since Canada references the National Institute for Occupational Safety and Health (NIOSH) approval that is covered under 42 Code of Federal Regulations (CFR) Part 84 in the United States (see 4.1.1.2). 7.1.2 Medical face masks No comparison is provided since Canada references ASTM F2100, as used in the United States (see 4.1.2.2). If a visor is attached to the medical face mask, it must conform to the applicable criteria in the standard CSA Z94.3.1 (see 7.2). 7.1.3 Community face coverings No Canadian standards for community face coverings have been identified. According to Health Canada,63 “Health Canada has not set out or endorsed any standards for face coverings at this time. We are actively monitoring the development of standards for face coverings and may revise our position when new information becomes available.” A number of reference documents outline the preferred material, design, and best practices for wearing face coverings. These include: • AFNOR Spec: Barrier masks V1.0 by the French Standardization Association • CWA 17553:2020: “Community face coverings—guide to minimum requirements, methods of testing, and use” by the European Committee for Standardization • Québec Standards Bureau (BNQ) Attestation document 1922­ –900, an attestation program for face coverings established by the province of Québec and certified by “le Bureau de Normalisation du Québec.” Table 7.1 shows the requirements for community face coverings defined in the BNQ 1922-900 standard compared to those of the EU and US markets. 63 https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/personal-protective-equipment/ medical-masks-respirators/face-covering-classifications-notice.html. 161 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 7.1: Comparison between EU, US, and Canadian (Province of Québec) standards for community face coverings Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.3 of this guide. Color code: Green: Products made to the BNQ 1922-900 standard are likely to meet or exceed the EU or US standard Yellow: Products made to the BNQ 1922-900 standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the BNQ 1922-900 standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Canada Québec Province EU (Market) Spec 1922-900/2020 US CWA 17553:2020 COMPARISON/COMMENTS standard (including mod. 2, 2021- ASTM F3502-21 08-03) Characteristic/ Requirement/testing Requirement/testing Requirement/testing No National Canadian property method method method Standard ≤ 70 Pa/cm2 EN 13274-3 (inhalation ≤ 6 mm H2O/cm2 Subpart K of 42 CFR Part 84, In the EU, either breathing Breathing resistance of 2.4 mbar; modified by § 8.2 (59 Pa/cm ) 2 resistance or air permeability resistance exhalation resistance 3 EN 14683:2019, Annex C (Level 1 ≤ 15 mm H2O are measured mbar) Level 2 ≤ 5 mm H2O) EN 14683:2019, Annex C (≥ 96 l/s/m2 @ 100 Pa) Air permeability n/a n/a EN ISO 9237 (Level 90% ≥ 90% ≥ 80% filtration efficiency Level 70% ≥ 70%) Test for filtration of 3 μm Particle filtration for particles of 20–800nm Subpart K of 42 CFR Part 84, Particle size 3 (± 0.5) μm particles is optional in Québec efficiency (PFE) modified by § 8.1 EN 13274-7 using NaCl EN ISO 16890-2 or (≥95%), Annex A, as modified; Annex A (as modified) (Level 1 ≥20%; Level 2 ≥ 50%) EN ISO 21083-1:2018 or limit is stricter than in EU BFE (see below) (Level 90% ≥ 90%; Manufacturer may choose Bacterial filtration efficiency (BFE) to provide the BFE results In the EU, either PFE or BFE Level 70% ≥ 70%) n/a (as per ASTM F 2101) along are measured EN 14683:2019 with PFE 162 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 7.2 Eye and face protection There are two relevant Canadian publications: a national standard, CSA Z94.3-20 (revised May 2021) “Eye and face protectors,” and a guideline, CSA Z94.3.1-16, “Guideline for selection, use, and care of eye and face protectors.” The standard CSA Z94.3-20 defines seven classes of protectors; the relevant ones for the purposes of this guide are: Class 1 (spectacles), 2 (goggles) and 6 (face shields). The standard contains general requirements (applicable to all classes) and class-specific requirements, while testing methods are included in Chapter 12 of the standard. The additional guideline mentioned complements the standard, providing advice for the proper selection of eye and face protection in relation to the specific hazardous activity involved. Table 7.2 shows the requirements for eye and face protection in the Canadian market compared to those of the EU and US markets. Table 7.2: Comparison between EU, US, and Canadian standards for eye and face protection Notes: • In general, requirements for lenses (only) have not been included. • For a more detailed comparison of EU and US standards (including test methods), see 4.2.1 of this guide. Color code: Green: Products made to the Canadian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Canadian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Canadian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Canada (Market) EU US COMPARISON/ standard EN 166:2001 CSA Z94.3-20, revised ANSI/ISEA Z87.1:2020 COMMENTS May 2021 Requirement/testing Requirement/testing Requirement/testing Characteristic/property method method method No specific testing done in Construction and Pass Pass n/a the CSA; covered by other materials (ANSI Z80.1) characteristics Headband Pass n/a n/a Called “general Basic (EU)/fundamental   requirements” in the   (US) requirements CSA (Class 1, 2) Called “field of view” in CSA Pass Field of vision ≥40° horizontally & n/a Different limits/method than (EN 168) ≥80° vertically in EU Min. dimensions are Not a requirement, provided in cl. 6.8 Ellipse with axes ≥40 mm Called “size” in CSA. Min. coverage area except for special uses (Classes 1, 2) and cl. and ≥ 33mm Generally same as in US 10.2.1 (Class 5) (Classes 1,2 and 6) ≥85% ≥78% (for double Transmittance of oculars > 74.4% ≥ 85% (or ≥ 78% if relaxed Limits/method similar as in glazed) without filtering action (EN 167) optics) US Clause 12.8.5 ≤2% (Classes 1, 2) ≤3% Same or stricter Haze n/a ≤3% (Class 6) (ASTM D1003-13) requirements as in US ASTM D1003 163 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Canada (Market) EU US COMPARISON/ standard EN 166:2001 CSA Z94.3-20, revised ANSI/ISEA Z87.1:2020 COMMENTS May 2021 Requirement/testing Requirement/testing Requirement/testing Characteristic/property method method method Pass Called “impact resistance” in Pass Increased robustness Pass CSA; using different steel ball (EN 168) Clauses 6.1, 12.2 diameter/speed than in EU Pass Not a requirement unless for Thermal stability n/a n/a (EN 168) use at extreme temperatures Pass Resistance to corrosion n/a Pass (EN 168) Pass Pass Very similar method to EU/ Resistance to ignition Pass (EN 168) Clause 12.3 US Particular requirements     (EU) No color present for No color present for goggles goggles No specific testing done Droplets and splashes of n/a in the CSA; covered by liquid Face shields pass the Face shields pass the area construction characteristics area coverage test coverage test (EN 168) (Classes 1, 2) Pass Called “side protection” in Lateral protection Pass Pass CSA; similar limits/different (optional) (EN 168) method than EU Clause 6.9 Optional requirements (EU) Resistance to fogging Time without fogging Time without fogging ≥ (only for oculars, not ≥8s n/a 8s complete eye protectors) (EN 168) Eye/face protection equipment used in health care settings are regulated as Class I medical devices in Canada, see 3.5.1. 7.3 Gloves 7.3.1 Medical examination gloves No comparison is made since Canada references ISO 11193-1 (the 2008 edition, even though recently a 2020 edition was issued), as well as ASTM D3578 used in the United States for rubber examination gloves. It also references ISO 11193-2:2006 for PVC gloves as well as ASTM standards for gloves made of other materials (for details of the ISO standards, see 4.3.1.1). In Canada, all medical gloves are Class II medical devices. 7.3.2 Surgical gloves No comparison is made since Canada references ISO 10282 (the 2002 edition, even though a 2014 edition exists), as well as ASTM D3577-19 (for details of the ISO standard, see 4.3.2.1). In Canada, all medical gloves are Class II medical devices. 164 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 7.4 Clothing 7.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) No comparison is made since Canada references EN 14126 (see 4.4.1.1 on EU market requirements). 7.4.2 Gowns In Canada the relevant standard is CSA Z314-2018, “Canadian medical device reprocessing” which, among others, replaced two standards on gowns: Z314.10.1, “Selection and use of gowns and drapes intended for use in health care facilities’, and Z314.10.2, “Laundering, maintenance, and preparation of reusable gowns, drapes, and wrappers for health care settings and laundries.” This standard is intended to address the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow, including, among others: • Selection and use of gowns and drapes (in Chapter 19) • Laundering, maintenance, and preparation of reusable gowns, drapes, and wrappers (in Chapter 20). The standard contains requirements from the applicable standard in the United States (ANSI/AAMI PB 72) regarding barrier properties and also explicit requirements for flammability and biocompatibility. Regarding other material properties, there are general requirements such as having sufficient strength to maintain integrity and sterility during normal handling and distribution, and resistance to tears and punctures during use but without reference to specific limits or testing methods. In this aspect it is noted that Health Canada accepts conformance to ASTM F2407-20 and recognizes EN 13795-1. Both standards cover single-use and reusable gowns; for details on their requirements see 4.4.2. Finally, while CSA Z314 addresses both surgical and isolation gowns, it does not address single-use or disposable gowns. Table 7.3 shows the requirements for medical gowns in the Canadian market compared to those of the EU and US markets. 165 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 7.3: Comparison between EU, US, and Canadian standards for gowns Note: For a more detailed comparison of EU and US standards (including test methods), see 4.4.2.3 of this guide. Color code: Green: Products made to the Canadian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Canadian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed —products made to the Canadian standard are not likely to meet the Red: Significantly different criteria­ EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. US Canada ANSI/AAMI PB70:2012 EU CSA Z314-2018 (all gowns) (Market) COMPARISON/ EN 13795-1:2019 (only reusable ASTM F2407-20 standard COMMENTS Surgical gowns surgical/isolation (surgical gowns) and gowns) ASTM F3352-19 (isolation gowns) Requirement/testing Requirement/testing Requirement/testing Characteristic/property method method method ≤ 300 CFU (less critical areas) AAMI PB 70 standard Note: For critical product specifically excludes dry Resistance to dry areas, wet bacterial n/a n/a microbial penetration microbial penetration from penetration limits apply instead its scope EN ISO 22612:2005 IB ≥ 2.8 (critical areas, standard performance) US requires (only for Level Resistance to wet 4) a stricter characteristic IB = 6.0 (critical areas, n/a n/a bacterial penetration (viral penetration; see next high performance) row in table) EN ISO 22610:2006 Pass (AQL 4%, Pass (AQL 4%, RQL=20%) RQL=20%) Viral penetration n/a (AAMI Level 4) (AAMI Level 4) ASTM F1671 ASTM F1671 ≤ 300 CFU/100 cm 2 Cleanliness microbial/ n/a n/a bioburden EN ISO 11737-1:2018 Health Canada accepts Log10 (lint count) ≤ 4.0 Requirement included by reference the limits/ Particle release but no limits or testing Optional in the US methods in the EN and EN ISO 9073-10:2004 methods are specified ASTM standards For critical areas/zones, US limits are the same ≥ 20 cm H2O (critical ≥ 20 cm H2O (AAMI ≥ 20 cm H2O (AAMI Level as EU ones (for standard areas, std. performance) Level 2) 2) performance) or lower (for ≥ 100 cm H2O (critical ≥ 50 cm H2O (AAMI ≥ 50 cm H2O (AAMI Level high performance) Water resistance areas, high performance) Level 3) 3) Limits in the US apply only (hydrostatic pressure) ≥ 10 cm H2O (less critical to critical zone components (AQL 4%, RQL=20%) (AQL 4%, RQL=20%) areas) (akin to critical areas in the AATC 127 AATC 127 EU); EN ISO 811:2018 EU and US methods are similar 166 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US Canada ANSI/AAMI PB70:2012 EU CSA Z314-2018 (all gowns) (Market) COMPARISON/ EN 13795-1:2019 (only reusable ASTM F2407-20 standard COMMENTS Surgical gowns surgical/isolation (surgical gowns) and gowns) ASTM F3352-19 (isolation gowns) Requirement/testing Requirement/testing Requirement/testing Characteristic/property method method method ≤ 4.5 g (AAMI Level 1) ≤ 4.5 g (AAMI Level 1) Limits in the US apply only to critical zone components ≤ 1.0 g (AAMI Level 2 ≤ 1.0 g (AAMI Level 2 Water resistance (impact and 3) and 3) (akin to critical areas in the n/a penetration) EU) (AQL 4%, RQL=20%) (AQL 4%, RQL=20%) AATC 42 or NWSP 80.3 AATC 42 or NWSP 80.3 ≥ 40 kPa Bursting strength (dry) ≥ 40 kPa (critical areas) n/a n/a (wet) EN ISO 13938:1:1999 Health Canada accepts by reference the limits/ methods in the EN and ASTM standards. ≥ 20 N In the US, additionally, Tensile strength (dry) ≥ 20 N (critical areas) Requirement included ≥ 30 N limits are set for tear but no limits/testing (wet) EN 29073-3:1992 methods specified ASTM D5034 strength (≥ 10 N per ASTM D5587 or D5733) and seam strength (≥ 30 N per ASTM D1683/D1683M); physical property limits are same for all barrier levels per AAMI Pass Pass Pass Biocompatibility ANSI/AAMI BE78 or ISO EN ISO 10993-1:2009 ISO 10993-1:2009 10993-10 Packaging for terminally sterilized medical Typically, reusable Assurance level of Sterility devices is recommended gowns will be sterilized sterilization process: at According to EN ISO 11607 after purchase/use least 10-6 series Manufacturer to provide Class 1 Class 1 Flammability fire risk information 16 CFR 1610 16 CFR 1610 Canadian standard states: “Gowns should, to the greatest extent possible, be comfortable” Optional: Note: The comfort and - Water vapor Comfort (depends on a usability of gowns can be transmission rate influenced by a number of Other criteria to consider variety of properties) Optional (ASTM D6701) factors, including design, - Evaporative resistance fit, breathability, weight, (ASTM F1868, Part B) “hand” (that is, the overall - etc. feel of the material), electrostatic properties, light reflectance (glare), and odor” Surgical/isolation gowns are regulated as Class I medical devices in Canada; see 3.5.1. 167 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 8 PRODUCT-SPECIFIC COMPARISONS (COLOMBIA) 8.1 Masks 8.1.1 Respirators The relevant Colombian standards for respiratory protection devices (RPD) are: • NTC 3852:2020, “Respiratory protection devices—filtering half-masks protection against particles­ — requirements, tests, marking,” which is identical to EN 149:2001+A1:2009 (current) • NTC 6486:2020: “Respiratory protective devices,” a comprehensive native standard which covers devices for protection against harmful atmospheres or escape from them, powered or not. Among others, this standard adopts the requirements in US 42 Code of Federal Regulations (CFR) Part 84 for N series respirator masks • Lastly, NTC 6435:2020, “Standard practice for respiratory protection” is an adoption of ASTM F3387-19, which is not a product standard but provides guidance on the selection, proper use, and maintenance of RPD. Table 8.1 shows the requirements for respirators in the Colombian market compared to those of the EU and US markets. 168 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 8.1: Comparison between EU, US, and Colombian standards for respirators Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 of this guide. Color code: Green: Products made to the Colombian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Colombian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Colombian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. EU Colombia Colombia US EN 149:2001 (Market) NTC 3852:2020, NTC 6486:2020, 42 CFR Part 84, COMPARISON/ +A1:2009, standard Classes FFP2 and Series/Levels N95 Series/Levels N95 COMMENTS Classes FFP2 and FFP3 and N99 and N99 FFP3 The two Colombian standards are identical Characteristic/ Requirement/ Requirement/ Requirement/ Requirement/ adoptions of EN 149 and property testing method testing method testing method testing method US Federal regulations, respectively N95 and N99 respirators according to NTC 6486 Practical Pass Pass Pass Pass cannot be magenta in performance color (reserved for P100 ones) FFP2 FFP2 ≤ 11% (individual) ≤ 11% (individual) n/a n/a ≤ 8% (mean) ≤ 8% (mean) Total inward leakage FFP3 FFP3 ≤ 5% (individual) ≤ 5% (individual) n/a n/a ≤ 2 % (mean) ≤ 2 % (mean) FFP2 FFP2 N95 N95 ≥ 94% @ 95 L/min ≥ 94% @ 95 L/min ≥ 95% @ 85 L/min ≥ 95% @ 85 L/min (NaCl and paraffin (NaCl and paraffin (NaCl only) (NaCl only) oil— EN 13274-7) oil—EN 13274-7) Filtering efficiency N99 N99 FFP3 FFP3 ≥ 99%@ 85 L/min ≥ 99%@ 85 L/min ≥ 99% @ 95 L/min ≥ 99% @ 95 L/min (NaCl only) (NaCl only) (NaCl and paraffin (NaCl and paraffin oil— EN 13274-7) oil—EN 13274-7) Compatibility with Pass Pass n/a n/a skin Flammability Pass Pass n/a n/a Average ≤ 1% by Average ≤ 1% by Carbon dioxide volume in “dead volume in “dead n/a n/a content space” space” Field of vision Pass Pass Pass Pass FFP2 FFP2 N95 ≤ 70 Pa @ 30 L/min N95 In NTC 6486 limit is ≤ 70 Pa @ 30 L/min ≤ 343 Pa @ 85 L/ ≤ 240 Pa @ 95 L/min ≤ 343 Pa @ 85 L/min specified as 35 mm H2O Breathing ≤ 240 Pa @ 95 L/min min resistance N99 (inhalation) FFP3 FFP3 N99 ≤ 343 Pa @ 85 L/ ≤ 100 Pa @ 30 L/min ≤ 100 Pa @ 30 L/min ≤ 343 Pa @ 85 L/min As above min ≤ 300 Pa @ 95 L/min ≤ 300 Pa @ 95 L/min Breathing FFP2 and FFP3 FFP2 and FFP3 N95 and N99 N95 and N99 In NTC 6486 limit is resistance ≤ 300 Pa @160 L/ ≤ 300 Pa @160 L/ ≤ 245 Pa @ 85 L/min ≤ 245 Pa @ 85 L/min specified as 25 mm H2O (exhalation) min min 169 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 8.1.2 Medical face masks In Colombia there are national adoptions of both the EN and ASTM standards, namely NTC 1733:2020, “Surgical masks—requirements and test methods,” identical to EN 14683:2019, and NTC 6436:2020, “Standard specification for the performance of the materials used in medical masks,” identical to ASTM F2100-19 (since revised as ASTM F2100-21). Table 8.2 shows the requirements for medical face masks in the Colombian market compared to those of the EU and US markets. Table 8.2: Comparison between EU, US, and Colombian standards for medical face masks Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.2 of this guide. Color code: Green: Products made to the Colombian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Colombian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Colombian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. EU Colombia Colombia US (Market) COMPARISON/ EN 14683:2019 NTC 1733:2020 NTC 6436:2020 ASTM F2100–21 standard COMMENTS Types I, II and IIR Types I, II and IIR Levels 1, 2 and 3 Levels 1, 2 and 3 National adoptions of Characteristic/ Requirement/ Requirement/ Requirement/ Requirement/ both EN 14683 and ASTM property testing method testing method testing method testing method F2100 exist ≥ 95% (Type I) ≥ 95% (Type I) ≥ 95% (Level 1) ≥ 95% (Level 1) Bacterial filtration ≥ 98% (Types II, IIR) ≥ 98% (Types II, IIR) ≥ 98% (Levels 2,3) ≥ 98% (Levels 2,3) efficiency (BFE) Using ASTM F2101 Using ASTM F2101 <49 Pa/cm2 (Level 1) <49 Pa/cm2 (Level < 40 Pa/cm (Type 2 < 40 Pa/cm (Type 2 1) I, II) I, II) <58.8 Pa/cm2 Differential pressure < 60 Pa/cm < 60 Pa/cm2 (Type 2 <58.8 Pa/cm2 (Type IIR) IIR) (Levels 2 and 3) (Levels 2 and 3) (Tested at 8L/ (Tested at 8L/min min flowrate) flowrate) Using EN 14683 Using EN 14683 Sub-micron ≥ 95 (Level 1) ≥ 95 (Level 1) particulate filtration ≥ 98 (Levels 2,3) ≥ 98 (Levels 2,3) efficiency n/a n/a Both at 0.1 Both at 0.1 micron, micron, using ASTM F2299 using ASTM F2299 Not required ≥ 10.7 kPa (Level 1) ≥ 10.7 kPa (Level 1) (Types I, II) Not required (Types I, II) ≥16 kPa (Level 2) ≥16 kPa (Level 2) Splash-resistance ≥21.4 kPa (Level 3) ≥21.4 kPa (Level 3) pressure ≥ 16.0 kPa (Type IIR) ≥ 16.0 kPa (Type IIR) Using ISO Using ISO 22609:2004 Using ASTM F1862 Using ASTM F1862 22609:2004 ≤ 30 CFU/g ≤ 30 CFU/g Microbial cleanliness Using EN ISO 11737- Using EN ISO 11737- n/a n/a 1:2018 1:2018 Pass Pass Pass Pass Biocompatibility Using ISO EN 10993- Using EN ISO 10993- Using FDA Using ISO 10993-1 1:2009 1:2009 regulations Class 1 Class 1 Flame spread n/a n/a Using 16 CFR Part Using 16 CFR Part 1610 1610 170 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 8.1.3 Community face coverings The Colombian standard is NTC 6449:2020, “Masks (face masks) for use in environments other than the health sector.” The standard specifies the basic characteristics of bacterial filtration efficiency (BFE), breathing resistance (differential pressure), splash resistance and dimensions, and makes reference to EN as well as ASTM/AATC standards. Table 8.3 shows the requirements for community face coverings in the Colombian market compared to those of the EU and US markets. Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.3 of this guide. Table 8.3: Comparison between EU, US, and Colombian standards for community face coverings Color code: Green: Products made to the Colombian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Colombian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Colombian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Colombia (Market) EU US COMPARISON/ NTC 6449:2020 standard CWA 17553:2020 ASTM F3502-21 COMMENTS Requirement/testing Characteristic/ Requirement/testing Requirement/testing Method property method method EN 14683:2019, Annex C Subpart K of 42 CFR Part 84, For the EU, either Differential pressure ≤60 modified by §8.2 (≤ 70 Pa/cm2) breathing resistance or air Breathing Pa/cm2; (NTC 1733 or EN (Level 1 ≤ 15 mm H2O permeability is measured; resistance EN 13274-3 (Inhalation 14683:2019) NTC 1733 is identical to EN resistance of 2.4 mbar; Level 2 ≤ 5 mm H2O) 14683 exhalation resistance 3 mbar) EN ISO 9237 Air permeability n/a n/a (≥ 96 l/s/m2 @ 100 Pa) EN 13274-7:2019 Subpart K of 42 CFR Part 84, For the EU, either PFE or OR modified by §8.1 BFE is measured while for Particle EN ISO 16890-2 OR filtration EN ISO 21083-1:2018, Colombia only BFE; for efficiency (PFE) or measure BFE (see below) n/a PFE, the CEN Workshop (Level 1 ≥ 20%; Agreement (CWA) (Level 90% ≥ 90% Level 2 ≥ 50%) Level 70% ≥ 70%) provides for alternative Particle size 3 (± 0.5) μm methods Bacterial EN 14683:2019 Manufacturer may choose filtration ≥ 90% to provide the BFE results NTC equals or exceeds the efficiency (BFE) (Level 90% ≥ 90% (NTC 1733 or EN 14683 or ASTM (as per ASTM F 2101) along requirements in the EU F2101) Level 70% ≥ 70%) with PFE Passes Splash (AATC 42/ISO 18695 or Only required in Colombia n/a n/a resistance AATC 22/ISO 4920 or ASTM F1862) 171 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 8.2 Eye and face protection In Colombia there are national adoptions of both the EN and US standards, namely NTC 6493:2020, “Individual eye protection—specifications,” identical to EN 166:2001 and NTC 3610:2020, “Eye and face personal protection devices at work and education,” identical to ANSI/ISEA Z87.1:2015 (there is now a 2020 edition). Table 8.4 shows the requirements for eye and face protection in the Colombian market compared to those of the EU and US markets. Table 8.4: Comparison between EU, US, and Colombian standards for eye and face protection Notes: • In general, requirements for lenses (only) have not been included. • For a more detailed comparison of EU and US standards (including test methods), see 4.2.1 of this guide. Color code: Green: Products made to the Colombian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Colombian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Colombian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. US (Market) EU Colombia Colombia ANSI/ISEA COMPARISON/COMMENTS standard EN 166:2001 NTC 6493:2020 NTC 3610:2020 Z87.1:2020 National adoptions of both EN Characteristic/ Requirement/ Requirement/ Requirement/ Requirement/ 166 and ANSI/ISEA Z87.1 (2015 property testing method testing method testing method testing method edition) exist Construction and Pass Pass Pass Pass materials (ANSI Z80.1) (ANSI Z80.1) Headband Pass Pass n/a n/a Basic (EU)/ fundamental (US)         requirements Pass Pass Field of vision (EN 168) (EN 168) Not a Not a requirement, requirement, Ellipse with axes Ellipse with axes Min. coverage area ≥40 mm and ≥ 33 ≥40 mm and ≥ 33 except for special except for special mm mm uses uses Transmittance of > 74.4% > 74.4% ≥ 85% (or ≥ 78% if oculars without ≥ 85% (EN 167) (EN 167) relaxed optics) filtering action ≤3% ≤3% Haze n/a n/a (ASTM D1003-13) (ASTM D1003-13) Pass Pass Increased robustness Pass Pass (EN 168) (EN 168) Pass Pass Thermal stability n/a n/a (EN 168) (EN 168) Resistance to Pass Pass Pass Pass corrosion (EN 168) (EN 168) Pass Pass Resistance to ignition Pass Pass (EN 168) (EN 168) 172 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US (Market) EU Colombia Colombia ANSI/ISEA COMPARISON/COMMENTS standard EN 166:2001 NTC 6493:2020 NTC 3610:2020 Z87.1:2020 National adoptions of both EN Characteristic/ Requirement/ Requirement/ Requirement/ Requirement/ 166 and ANSI/ISEA Z87.1 (2015 property testing method testing method testing method testing method edition) exist Particular requirements         (EU) No color present No color present No color present No color present for for goggles for goggles for goggles goggles Droplets and splashes Face shields pass Face shields pass Face shields pass Face shields pass of liquid the area coverage the area coverage the area coverage the area coverage test test test test (EN 168) (EN 168) Lateral protection Pass Pass Pass Pass (optional) (EN 168) (EN 168) Optional requirements (EU) Resistance to fogging Time without Time without n/a n/a (only for oculars, US requirement (same as in EU) fogging ≥ 8 s (EN fogging ≥ 8 s (EN not complete eye 168) was added in the 2020 edition 168) protectors) 8.3 Gloves 8.3.1 Medical examination gloves The relevant standards are NTC-ISO 11193-1:2020 (for gloves made of rubber/latex), identical to ISO 11193- 1:2008 (last revised in 2020) and NTC-ISO 11193-2:2020 (made of PVC), identical to ISO 11193-2:2006 (current). For details on the ISO standards, see 4.3.1.1. For completeness, the standards NTC 6492:2020, “Protection gloves­ —general requirements and test methods,” identical to EN 420:2004+A1:2010 (since replaced by EN ISO 21420), and NTC ISO 374-5:2020, “Protective gloves against dangerous chemicals and micro-organisms—Part 5: Terminology and performance requirements for micro-organisms risks,” identical to ISO 374-5:2016 (current), are also mentioned. As it has been analyzed in section 4.3.1.1 on EU requirements for examination gloves, standards on “protective gloves” (as opposed to “medical gloves”) will not be further detailed. Table 8.5 shows the requirements for medical examination gloves in the Colombian market compared to those of the EU and US markets. 173 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 8.5: Comparison between EU, US, and Colombian standards for medical examination gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.1.3 of this guide. Color code: Green: Products made to the Colombian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Colombian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Colombian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Colombia US Material-specific ASTM material specific EU (Market) NTC-ISO 11193-1:2020 D6319 (nitrile) COMPARISON/ EN 455 series standard (rubber) D3578 (rubber) COMMENTS NTC-ISO 11193-2:2020 D5250 (PVC) (PVC) D6977 (polychloroprene) Requirement/ Requirement/testing Requirement/testing Characteristic/property testing method method method AQL =1.5 AQL =2.5 AQL =2.5 Freedom from holes (EN 455-1:2020) (ASTM D5151) AQL = 4.0 In the EU, instead of Non-thermoplastic AQL, the median of 13 materials samples is used Nitrile ≥ 14MPa/elongation ≥6.0N AQL = 4.0 ≥400% For rubber In general, the tensile ≥ 6.0 N Latex (natural) properties and their Elongation ≥ 500% (Type 1) ≥ 14MPa / limits specified in the and ≥ 400% (Type 2) Colombian standards Force at break (N) / elongation ≥ 500% are an amalgam of the Tensile strength (MPa), EU/US ones elongation at break (%) Polychloroprene Thermoplastic ≥ 14MPa/elongation ≥ (Also, after ageing/ materials (PVC, PE) challenge) 400% Colombian and EU ≥ 3.6N standards specify For PVC PVC ≥ 11MPa/elongation ≥ minimum absolute force ≥ 7.0 N 300% (N) for samples taken Elongation ≥ 350% from the glove (varies (EN 455-2 :2015, (ASTM D412, ASTM D573 with thickness); ASTM method A of ISO [ageing]) specifies in terms of 23529:2010) tensile strength Pass (EN ISO 10993-5 Biocompatibility No explicit requirements Pass (FDA regulations) and -10) ≤ 2.0mg/glove (powder- The requirement was free gloves) first introduced in the ≤ 2.0 mg/glove 2020 edition of ISO 11193- Powder-residue content (EN 455-3, EN ISO n/a ≤ 10 mg/dm2 (powdered 1, while NTC-ISO 11193-1 21171:2006) gloves) is based on the 2008 (ASTM D6124) edition “Manufacturer shall ≤ 200 µg/dm2 monitor the content Aqueous soluble protein in natural rubber (only for rubber gloves) n/a content latex gloves and (ASTM D5712) shall try to minimize it” (EN 455-3) 174 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Colombia US Material-specific ASTM material specific EU (Market) NTC-ISO 11193-1:2020 D6319 (nitrile) COMPARISON/ EN 455 series standard (rubber) D3578 (rubber) COMMENTS NTC-ISO 11193-2:2020 D5250 (PVC) (PVC) D6977 (polychloroprene) Requirement/ Requirement/testing Requirement/testing Characteristic/property testing method method method ≤ 10 µg/dm2 Extractable antigenic Optional n/a (only for rubber gloves) protein content (ASTM D6499) EN 455-4 refers to If gloves are sterilized, the Pass EN ISO 11607 (sterile nature of the sterilization Sterility (US Pharmacopeia) barrier integrity process shall be disclosed on during shelf-life) request 8.3.2 Surgical gloves There appears to be no relevant NTC standard for surgical gloves, such as an adoption of ISO 10282. Therefore, no comparison to EU/US standards can be provided. 8.4 Clothing 8.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) It is noted that, unlike in most countries/regions covered in this guide, in Colombia there are also native- specific standards for disposable hats/caps and disposable foot covers. These two product types will be dealt with in a separate subsection. 8.4.1.1 Suits, coveralls, and aprons The relevant Colombian standards include the direct use or adoption of the majority of the corresponding ISO and EN ones: • ISO 13688 on general requirements of protective clothing has not been adopted. Instead, in Colombia, reference to the previous version of it, EN 340, is made • NTC 6434:2020, “Protective clothing—requirements and test methods for clothing protection against biological agents,” is identical to EN 14126:2003 (current) • EN 14325 has not been adopted, but the latest edition of it is referenced by NTC 6434 (see above) • NTC-EN 14605:2020, “Protective clothing against liquid chemicals—requirements performance for clothing with liquid-tight seams (Type 3) or with spray-tight joints (Type 4), including garments that offer protection only to certain parts of the body (Types PB [3] and PB [4]),” is identical to EN 14605:2005+A1:2009 (current) • NTC-EN 13034:2020, “Protective clothing against liquid chemicals—requirements performance for chemical protective clothing that offers protection limited against liquid chemicals (Types 6 and PB [6] equipment),” is identical to EN 13034:2005+A1:2009 (current) • The testing standards ISO 16603 (synthetic blood penetration) and ISO 16604 (bacteriophage method) are referenced directly, while the current editions of ISO 22610 (wet bacterial penetration) and ISO 22612 (dry microbial penetration) have been adopted as NTC-ISO ones. Table 8.6 shows the requirements for protective clothing in the Colombian market compared to those of the EU and US markets. 175 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 8.6: Comparison between EU, US, and Colombian standards for suits, coveralls, and aprons Notes: For a more detailed comparison of EU and US standards (including test methods), see 4.4.1 of this guide. For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components, such as visors, are not included). For protection against infective agents only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection­—Type 4), Type 6 (limited protection against liquid chemicals) and Type PB [6] (partial-body protection—Type 6). Color code: Green: Products made to the Colombian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Colombian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Colombian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Market EU Colombia US COMPARISON/ Characteristic/ Requirement/ Requirement/ Requirement/ COMMENTS property testing method testing method testing method I. General EN ISO EN 340:2003 NFPA 1999:2018 requirements 13688:2013+A1:2021 No harmful substances No harmful substances present present Innocuousness No specific requirements No azo dyes present No azo dyes present Acceptable (section 6.1) Note: Design requirements only ≥650 g/(m224 h) Note: In the US for single- use garments/ensembles Acceptable “moisture vapor transmission Design and Acceptable (Annex C) rate” is specified comfort (section 8.28 and ASTM E96) ≥450 W/m2 Note: In the US for multiple- use garments/ensembles “total heat loss test” is specified (section 8.32 and ASTM F1868) EN 14126:2003 and EN NTC 6434:2020 and NTC- II. Protection 14605:2005+A1:2009 (for EN 14605:2020 (for Types Types 4 and PB [4]) or EN 4 and PB[4]) or NTC-EN NFPA 1999:2018 against infective 13034:2005+A1:2009 (for 13034:2020 (for Types 6 agents Types 6 and PB [6]) and PB[6]) 1. Materials requirements a) Mechanical 176 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Colombia US COMPARISON/ Characteristic/ Requirement/ Requirement/ Requirement/ COMMENTS property testing method testing method testing method Abrasion resistance is Class 1 to 6 (highest) Class 1 to 6 (highest) considered as a precondition Abrasion (cl. 4.4 of EN 14325 and (cl. 4.4 of EN 14325 and to barrier performance of resistance EN ISO 12947-2) materials EN ISO 12947-2) (ASTM D4157) Class 1 to 6 (highest) Flex fatigue is considered Flex cracking Class 1 to 6 (highest) as a precondition to barrier (cl. 4.5, 4.6 EN 14325 and (cl. 4.5, 4.6 EN 14325 and resistance performance of materials EN ISO 7854, method B) EN ISO 7854, method B) (ASTM F392) Single-use: “Tear-resistance test two” ≥17 N (section 8.38 and ASTM D5733 Class 1 to 6 (highest) Class 1 to 6 (highest) for non-woven) Trapezoidal tear (EN 14325 and EN ISO (EN 14325 and EN ISO resistance 9073-4:1997) Multiple-use: “Tear- 9073-4:1997) resistance test one” ≥36 N (section 8.7 and ASTM D5587 for woven) ≥50 N (section 8.4 and ASTM Class 1 to 6 (highest) D5034) Bursting strength was Class 1 to 6 (highest) Tensile strength (cl. 4.9 of EN 14325 and EN (cl. 4.9 of EN 14325 and eliminated in EU and also Also bursting strength: ISO 13934-1) EN ISO 13934-1) not present in NTC ≥66N (single-use) ≥222.5N (multiple-use) (section 8.5 and ASTM D3787) ≥12N (single-use) Class 1 to 6 (highest) Class 1 to 6 (highest) Puncture (cl. 4.10 of EN 14325 and (cl. 4.10 of EN 14325 and ≥25N (multiple-use) resistance EN 863) EN 863) (section 8.6 and ASTM D2572) b) Chemical resistance Permeation by Class 1 to 6 (highest) Class 1 to 6 (highest) chemicals (EN ISO 6529, method A (EN ISO 6529, method A (applicable to for liquids) for liquids) Types 4 and PB [4]) Repellency to In the US, it is called liquids ≤30% “water-absorption Class 1 to 3 (highest) Class 1 to 3 (highest) resistance test”; it (section 8.31) (ISO 6530) (ISO 6530) (applicable to applies only to multiple- Types 6 and PB [6]) use garments/ensembles Penetration by liquids Class 1 to 3 (highest) Class 1 to 3 (highest) (ISO 6530) (ISO 6530) (applicable to Types 6 and PB [6]) c) Flammability Resistance to Pass or min. class 1 (cl. Flame spread time≥3.5 s Pass or min. class 1 (cl. ignition or flame 4.14 EN 14325 & EN 13274-4, 4.14 EN 14325 & EN 13274- (section 8.39 and ASTM (more stringent) method 3) 4, method 3) D1230) d) Penetration by infective agents Contaminated Class 1 to 6 (highest) Pass liquids under Class 1 to 6 (highest) Note: In the US the “bio- (cl. 4.1.4.1 of EN 14126,(cl. 4.1.4.1 of EN 14126, ISO hydrostatic penetration test one” applies ISO 16603 and ISO 16604) 16603 and ISO 16604) (section 8.3 and ASTM F1671) pressure 177 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Colombia US COMPARISON/ Characteristic/ Requirement/ Requirement/ Requirement/ COMMENTS property testing method testing method testing method Mechanical contact with Class 1 to 6 (highest) Class 1 to 6 (highest) contaminated ISO 22610:2018 has been (cl. 4.1.4.2 of EN 14126 and (cl. 4.1.4.2 of EN 14126 and n/a liquids (wet NTC- ISO 22610) adopted as NTC-ISO EN ISO 22610) bacterial penetration) (Biologically) Class 1 to 3 (highest) Class 1 to 3 (highest) contaminated n/a (cl. 4.1.4.3 of EN 14126) (cl. 4.1.4.3 of EN 14126) liquid aerosols Contaminated As above As above solid particles ISO 22612:2006 has been (cl. 4.1.4.4 of EN 14126 and (cl. 4.1.4.4 of EN 14126 and n/a (dry microbial NTC-ISO 22612) adopted as NTC-ISO ISO 22612) penetration) 2. Whole-suit requirements Pass Pass Pass (section 8.2) (EN ISO 17491-4 (method (EN ISO 17491-4 (method Mist test (Type 6) Note: In the US the “liquid A) as modified by cl. 5.2 of A) as modified by cl. 5.2 tight integrity test one” EN 13034) of EN 13034) applies Pass Pass Liquid spray test Pass (cl. 4.3.4.2 etc. of EN (cl. 4.3.4.2 etc. of EN (section 8.2) (Type 4) 14605 and EN ISO 17491-4 14605 and EN ISO 17491-4 [method B]) [method B]) Pass Pass Demonstration of garment Practical (EN 14605/EN (EN 14605/EN functionality is included as 13034—“seven 13034—”seven part of the liquid integrity performance movements” sequence movements” sequence testing applied to garments while wearing the suit) while wearing the suit) (ASTM F1154) 8.4.1.2 Head and shoe covers In Colombia there are national standards specific for disposable head and shoe covers (typically used in health care settings). These are: • NTC 6457:2020, “Disposable hats/caps,” which includes requirements present in EN 14683 (medical face masks) such as splash-resistance and bacterial filtration efficiency, as well as requirements in EN 13795-1 (for surgical gowns), such as particle release and tensile strength • NTC 6451:2020, “Disposable foot covers,” which includes requirements present in EN 14683 (medical face masks) such as splash resistance, as well as requirements in EN 13795-1 (for surgical gowns), such as tensile strength. Because of the above characteristics, comparison of requirements is not made against EU/US standards for protective clothing but against those for gowns (see also 8.4.2). As would be expected, only a few of the requirements for gowns apply to head and shoe covers because of their limited body coverage and less critical areas. It is also emphasized that surgical caps and shoe covers are excluded from the scope of the ANSI/AAMI PB70:2012 and ASTM F2407-20 standards valid in the United States. Therefore, the US column has limited use and is only retained for consistency of format. Table 8.7 shows the requirements for head and shoe covers in the Colombian market compared to those of the EU and US markets. 178 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 8.7: Comparison between EU, US, and Colombian standards for head and shoe covers Notes: For a more detailed comparison of EU and US standards (including test methods), see 4.4.2.3 of this guide. For simplicity, only requirements related to barrier performance of gown materials and seams are specified. Color code: Green: Products made to the Colombian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Colombian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Colombian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Colombia US ANSI/AAMI PB70:2012 EU NTC 6457:2020 (all gowns) (Market) COMPARISON/ EN 13795-1:2019 Head covers ASTM F2407-20 standard COMMENTS Surgical gowns (surgical gowns) NTC 6451:2020 and ASTM F3352-19 Shoe covers (isolation gowns) Requirement/testing Requirement/testing Requirement/testing Characteristic/property method method method 1. Only a requirement in For head covers: Colombia ≥12 g/m2 2. The Colombian Density of material n/a n/a For shoe covers: standards specify that ≥30 g/m2 non-woven fabrics must be used ≤ 300 CFU (less critical areas) AAMI PB 70 standard Note: For critical product specifically excludes dry Resistance to dry areas, wet bacterial n/a n/a microbial penetration microbial penetration from penetration limits apply instead its scope EN ISO 22612:2005 IB ≥ 2.8 (critical areas, standard performance) US requires (only for Level Resistance to wet 4) a stricter characteristic IB = 6.0 (critical areas, high n/a n/a bacterial penetration (viral penetration; see next performance) row in table) EN ISO 22610:2006 Pass (AQL 4%, RQL=20%) (AAMI Level 4) Viral penetration n/a n/a ASTM F1671 ≤ 300 CFU/100 cm2 Cleanliness microbial/ n/a n/a bioburden EN ISO 11737-1:2018 For head covers: Optional in the US Log10 (lint count) ≤ 4.0 Log10 (lint count) ≤ 4.0 *Note: It is assumed that Particle release EN ISO 9073-10:2004 ISO 9073-10 the requirement is also not n/a For shoe covers: applicable for shoe covers Note* n/a in the EU 179 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Colombia US ANSI/AAMI PB70:2012 EU NTC 6457:2020 (all gowns) (Market) COMPARISON/ EN 13795-1:2019 Head covers ASTM F2407-20 standard COMMENTS Surgical gowns (surgical gowns) NTC 6451:2020 and ASTM F3352-19 Shoe covers (isolation gowns) Requirement/testing Requirement/testing Requirement/testing Characteristic/property method method method ≥ 20 cm H2O (critical areas, ≥ 20 cm H2O (AAMI Level std. performance) 2) ≥ 100 cm H2O (critical Water resistance ≥ 50 cm H2O (AAMI Level areas, high performance) n/a 3) (hydrostatic pressure) ≥ 10 cm H2O (less critical (AQL 4%, RQL=20%) areas) AATC 127 EN ISO 811:2018 ≤ 4.5 g (AAMI Level 1) Water resistance (impact Test in Colombian standard n/a ≥ 16kPa ≤ 1.0 g (AAMI Levels 2, 3) penetration) used as an alternate to (AQL 4%, RQL=20%) splash resistance (see row ISO 22609 below) AATC 42 or NWSP 80.3 ≥ 16kPa Alternatively, use the Splash resistance n/a n/a water impact penetration ISO 18695 test above For head covers: NTC is identical to Bacterial filtration ≥ 90% efficiency (BFE) EN; in the EU/US this n/a n/a NTC 1733 or EN 14683 requirement applies only to medical face masks For shoe covers: n/a ≥ 20 N In the Colombian ≥ 20 N Tensile strength (dry) ≥ 20 N (critical areas) ≥ 30 N standards, testing only NTC 2600 or ISO 9073-3 in dry state is performed; (wet) EN 29073-3:1992 ASTM D5034 NTC 2600 is identical to ISO 9073-2 For head covers: use Pass materials compatible Pass Biocompatibility with skin EN ISO 10993-1:2009 ANSI/AAMI BE78 or ISO 10993-10 For shoe covers: n/a Class 1 Manufacturer to provide Flammability n/a fire risk information 16 CFR 1610 180 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 8.4.2 Gowns The relevant Colombian Standard, NTC 5623:2020, “Surgical drapes and sheets—requirements and test methods. Part 1: Surgical drapes and gowns,” is identical to EN 13795-1:2019 (current—for details on the EN, see 4.4.2.1). Table 8.8 shows the requirements for gowns in the Colombian market compared to those of the EU and US markets. Table 8.8: Comparison between EU, US, and Colombian standards for gowns Notes: For a more detailed comparison of EU and US standards (including test methods), see 4.4.2.3 of this guide. For simplicity, only requirements related to barrier performance of gown materials and seams are specified. Color code: Green: Products made to the Colombian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Colombian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Colombian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. US ANSI/AAMI PB70:2012 (all EU Colombia (Market) gowns) COMPARISON/ EN 13795-1:2019 NTC 5623:2020 standard ASTM F2407-20 (surgical COMMENTS Surgical gowns Surgical gowns gowns) and ASTM F3352-19 (isolation gowns) Characteristic/ Requirement/testing Requirement/testing Requirement/testing NTC 5623 is an identical property method method method adoption of EN 13795-1 ≤ 300 CFU (less critical ≤ 300 CFU (less critical areas) areas) AAMI PB 70 standard Note: For critical Note: For critical specifically excludes dry Resistance to dry product areas, wet product areas, wet n/a microbial penetration microbial penetration from bacterial penetration bacterial penetration limits apply instead limits apply instead its scope EN ISO 22612:2005 BS EN ISO 22612:2005 IB ≥ 2.8 (critical areas, IB ≥ 2.8 (critical areas, standard performance) standard performance) US requires (only for Level Resistance to wet 4) a stricter characteristic IB = 6.0 (critical areas, IB = 6.0 (critical areas, n/a bacterial penetration (viral penetration; see next high performance) high performance) row in table) EN ISO 22610:2006 EN ISO 22610:2006 Pass (AQL 4%, RQL=20%) Viral penetration n/a n/a (AAMI Level 4) ASTM F1671 ≤ 300 CFU/100 cm2 ≤ 300 CFU/100 cm2 Cleanliness microbial/ n/a bioburden EN ISO 11737-1:2018 EN ISO 11737-1:2018 Log10 (lint count) ≤ 4.0 Log10 (lint count) ≤ 4.0 Particle release Optional in the US EN ISO 9073-10:2004 EN ISO 9073-10:2004 181 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US ANSI/AAMI PB70:2012 (all EU Colombia (Market) gowns) COMPARISON/ EN 13795-1:2019 NTC 5623:2020 standard ASTM F2407-20 (surgical COMMENTS Surgical gowns Surgical gowns gowns) and ASTM F3352-19 (isolation gowns) Characteristic/ Requirement/testing Requirement/testing Requirement/testing NTC 5623 is an identical property method method method adoption of EN 13795-1 For critical areas/zones, US limits are the same as ≥ 20 cm H2O ≥ 20 cm H2O (critical areas, std. (critical areas, std. EU/Colombian ones (for performance) performance) standard performance) ≥ 20 cm H2O (AAMI Level 2) or lower (for high ≥ 100 cm H2O ≥ 100 cm H2O Water resistance ≥ 50 cm H2O (AAMI Level 3) performance). (critical areas, high (critical areas, high (hydrostatic pressure) performance) performance) Limits in the US apply only (AQL 4%, RQL=20%) to critical zone components ≥ 10 cm H2O (less ≥ 10 cm H2O (less AATC 127 critical areas) critical areas) (akin to critical areas in EU/ Colombia). EN ISO 811:2018 EN ISO 811:2018 EU/Colombia and US methods are similar Limits in the US apply only ≤ 4.5 g (AAMI Level 1) to critical zone components Water resistance ≤ 1.0 g (AAMI Levels 2, 3) (akin to critical areas in the n/a n/a (impact penetration) EU/UK) (AQL 4%, RQL=20%) AATC 42 or NWSP 80.3 ≥ 40 kPa ≥ 40 kPa Bursting strength (dry) ≥ 40 kPa (critical areas) ≥ 40 kPa (critical areas) (wet) EN ISO 13938:1:1999 EN ISO 13938:1:1999 Higher limit in the US compared to the EU/UK. Additionally, limits are set ≥ 20 N ≥ 20 N for tear strength (≥ 10 N Tensile strength (dry) ≥ 20 N (critical areas) ≥ 20 N (critical areas) ≥ 30 N per ASTM D5587 or D5733) (wet) EN 29073-3:1992 EN 29073-3:1992 ASTM D5034 and seam strength (≥ 30 N per ASTM D1683/D1683M). Physical property limits are same for all barrier levels per AAMI Pass Pass Pass Biocompatibility ANSI/AAMI BE78 or ISO EN ISO 10993-1:2009 EN ISO 10993-1:2009 10993-10 Packaging for Packaging for terminally sterilized terminally sterilized Assurance level of medical devices medical devices Sterility sterilization process: at is recommended is recommended least 10-6 according to EN ISO according to EN ISO 11607 series 11607 series Manufacturer to Manufacturer to Class 1 Flammability provide fire risk provide fire risk information information 16 CFR 1610 Optional: - Water vapor transmission Comfort (depends on a Comfort (depends on a rate Other criteria to variety of properties) variety of properties) (ASTM D6701) consider - Evaporative resistance (ASTM F1868, Part B) - etc. 182 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 9 PRODUCT-SPECIFIC COMPARISONS (INDIA) 9.1 Masks 9.1.1 Respirators The applicable standard, IS 9473:2002 (reaffirmed 2019), “Respiratory protective devices—filtering half- masks to protect against particles­—specification,” is based on a previous edition (1991) of EN 149. EN 149 has since been revised in a 2001 edition and an amendment was issued in 2009. Table 9.1 shows the main product requirements for respirators in the Indian market compared to those of the EU and US markets. Table 9.1: Comparison between EU, US, and Indian standards for respirators Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 of this guide. Color code: Green: Products made to the Indian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Indian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Indian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. US EU India (Market) 42 CFR Part 84, Series/ EN 149:2001 +A1:2009, IS 9473:2002, COMPARISON/COMMENTS standard Levels N95 and N99 Classes FFP 2 and FFP 3 Classes FFP2 and FFP 3 Note: Other classes of Characteristic/ Requirement/testing Requirement/testing Requirement/testing respirators are not included— property method method method not suitable for COVID-19 context Practical In the US, fit testing before use Pass Pass Pass performance (required by OSHA, not NIOSH) FFP2 FFP2 In the US, not specified in 42 ≤ 11% (individual) ≤ 11% (individual) n/a CFR Part 84 Total inward ≤ 8% (mean) ≤ 8% (mean) leakage FFP3 FFP3 In the US, not specified in 42 ≤ 5% (individual) ≤ 5% (individual) n/a CFR Part 84 ≤ 2 % (mean) ≤ 2 % (mean) 183 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US EU India (Market) 42 CFR Part 84, Series/ EN 149:2001 +A1:2009, IS 9473:2002, COMPARISON/COMMENTS standard Levels N95 and N99 Classes FFP 2 and FFP 3 Classes FFP2 and FFP 3 Note: Other classes of Characteristic/ Requirement/testing Requirement/testing Requirement/testing respirators are not included— property method method method not suitable for COVID-19 context Note 1: Specified as max penetration of 6% Note 2: Specified as max penetration of 2 % FFP2 Different limits apply in India FFP2 N95 ≥ 94% @ 95 L/min (NaCl)— for NaCl and paraffin oil ≥ 94% @ 95 L/min ≥ 95%@ 85 L/min (NaCl Note 1 (stricter) aerosols (NaCl and paraffin oil, EN only) ≥ 98% @ 95 L/min (paraffin Limits are close but not 13274-7) oil)—Note 2 identical between India and the EU Unlike in the EN, method is directly contained in the Indian Filtering standard efficiency Note 3: Specified as max penetration of 3% Note 4: Specified as max penetration 1% FFP 3 Different limits apply in India FFP3 ≥ 97% @ 95 L/min (NaCl)— N99 for NaCl and paraffin oil ≥ 99% @ 95 L/min Note 3 ≥ 99% @ 85 L/min NaCl (stricter) aerosols (NaCl and paraffin oil, EN only) Limits are close but not 13274-7) ≥ 99% @ 95 L/min (paraffin identical between India and oil)—Note 4 the EU Unlike in the EN, method is directly contained in the Indian standard Compatibility Pass Pass n/a with skin Flammability Pass Pass n/a Carbon dioxide Average ≤ 1% by volume in Average ≤ 1% by volume in n/a content “dead space” “dead space” Field of vision Pass Pass Pass Performance criteria same and FFP2 FFP2 test methods similar between N95 ≤ 70 Pa @ 30 L/min ≤ 70 Pa @ 30 L/min EU and India ≤ 343 Pa @ 85 L/min Breathing ≤ 240 Pa @ 95 L/min ≤ 240 Pa @ 95 L/min resistance Performance criteria same and (inhalation) FFP 3 FFP 3 N99 test methods similar between ≤ 100 Pa @ 30 L/min ≤ 100 Pa @ 30 L/min ≤ 343 Pa @ 85 L/min) EU and India ≤ 300 Pa @ 95 L/min ≤ 300 Pa @ 95 L/min Performance criteria same and Breathing test methods similar between FFP2 and FFP3 N95 and N99 resistance ≤ 300 Pa @160 L/min EU and India ≤ 300 Pa @160 L/min ≤ 245 Pa @ 85 L/min (exhalation) Respirators meant to be used in health care settings are regulated as medical devices (Class B) in India; see 3.7.1. 184 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 9.1.2 Medical face masks The relevant standard is IS 16289:2014 (reaffirmed 2019), “Medical textiles—surgical face masks— specification.” The scope of the standard covers not only masks used during surgical procedures, but also encompasses other health services. The standard defines three Classes (1, 2, and 3) of masks. Class 1 has min. 95 percent bacterial filtration efficiency (BFE), while Classes 2 and 3 have min. 98 percent BFE. Unlike in the United States, only the highest class (3) has splash-resistance properties, and it is also the only class where requirements for sub-micron particulate filtration efficiency are defined. The testing methods are defined in the standard itself with the exception of BFE testing, which is done according to IS 16288:2014 (reaffirmed 2019), similar to corresponding US/ISO methods. Table 9.2 shows the requirements for medical face masks in the Indian market compared to those of the EU and US markets. Table 9.2: Comparison between EU, US, and Indian standards for medical face masks Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.2 of this guide Color code: Green: Products made to the Indian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Indian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Indian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. EU India US (Market) EN 14683:2019 IS 16289:2014 ASTM F2100–21 COMPARISON/COMMENTS standard Types I, II and IIR Classes 1, 2 and 3 Levels 1, 2 and 3 Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method ≥ 95% (Class 1) Bacterial filtration ≥ 95% (Type I) ≥ 95% (Level 1) Essentially the same to both EU/US ≥ 98% (Types II, IIR) ≥ 98% (Levels 2,3) Using (for corresponding types) efficiency (BFE) ≥ 98% (Classes 2, 3) ASTM F2101 Using IS 16288:2014 < 29.4 Pa/cm2 < 40 Pa/cm2 (Type (Classes 1, 2) <49 Pa/cm2 (Level 1) I, II) Indian standards are same or Differential < 49 Pa/cm2 stricter than EU/US equivalents for < 60 Pa/cm2 (Types (Class 3) <58.8 Pa/cm2 different categories (that is, same pressure IIR) (Levels 2, 3) or better breathability) (Tested at 8L/min (Tested at 8L/min flowrate) Using EN 14683 flowrate) Not required (Classes ≥ 95 (Level 1) Sub-micron 1, 2) Classes 1 and 2 of Indian standard particulate not required to be tested; Class filtration efficiency n/a ≥ 98% (Class 3) ≥ 98 (Levels 2,3) 3 has same requirements as US Level 3 Using latex spheres Both at 0.1 micron, using ASTM F2299 Not required (Classes ≥ 10.7 kPa (Level 1) 1, 2) Note 1 - specified as ≥120 mm Hg Not required (Types ≥16 kPa (Level 2) Splash-resistance I, II) ≥16 kPa (Class 3) ≥21.4 kPa (Level 3) pressure ≥ 16.0 kPa (Type IIR) Note 1 Using ISO 22609:2004 Using ISO 22609:2004 Using ASTM F1862 Microbial ≤ 30 CFU/g Using EN ISO 11737- n/a n/a cleanliness 1:2018 185 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets EU India US (Market) EN 14683:2019 IS 16289:2014 ASTM F2100–21 COMPARISON/COMMENTS standard Types I, II and IIR Classes 1, 2 and 3 Levels 1, 2 and 3 Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method Pass Pass Biocompatibility Using ISO EN 10993- n/a Using ISO 10993-1 1:2009 Class 1 Flame spread n/a n/a Using 16 CFR Part 1610 Medical face masks are regulated as medical devices (Class B) in India; see 3.7.1. 9.1.3 Community face coverings There is not yet a relevant standard or specification in India (under development). Therefore, no comparison to EU or US requirements can be made. 9.2 Eye and face protection IS 5983:1980 (reaffirmed in 2018),“Specification for eye protectors,” is based on (but is not identical to) ISO 4849 “Personal eye protectors—specifications,” ISO 4850 (welding applications), and ISO 4851 (protection against UV radiation). These three ISO standards were replaced in 2021 by the ISO 16321 series of standards (three parts). IS 5983 references two testing standards: IS 7524-1:1980 (reaffirmed 2018) for non-optical methods and IS 7524-2:1979 (reaffirmed 2018) for optical methods, based on ISO 4855 and ISO 4854, respectively. These ISO standards were replaced in 2020 by the ISO 18526 series of standards (four parts) and, following that, the IS 7524 series of standards (Parts 1 to 4) were issued/revised, being identical to the corresponding parts of ISO 18526. Nevertheless, in the table below, the previous editions of IS 7524-1 and IS 7524-2 are used, as they are dated references in IS 5983. Additionally, there is another relevant product standard, IS 8521-1:1977 (reaffirmed 2018), “Specification for industrial face shields—Part I: With plastic visor.” This standard, among others, contains requirements for impact and penetration resistance, flammability, and disinfection. Table 9.3 shows the requirements for eye and face protection in the Indian market (using only IS 5983) compared to those of the EU and US markets. 186 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 9.3: Comparison between EU, US, and Indian standards for eye and face protection Notes: • In general, requirements for lenses (only) have not been included. • Requirements only for the following uses of eye protectors in the Indian standard are included: “general purpose” and “splashes.” For a more detailed comparison of EU and US standards (including test methods), see 4.2.1 of this guide. Color code: Green: Products made to the Indian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Indian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Indian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. EU India US (Market) EN 166:2001 IS 5983:1980 ANSI/ISEA Z87.1-2020 COMPARISON/COMMENTS standard (reaffirmed 2018) Characteristic/property Requirement/ Requirement/testing Requirement/testing testing method method method Pass Construction and materials Pass (ANSI Z80.1) Headband Pass Width ≥ 10mm n/a Basic (EU)/fundamental Called “general requirements” in     (US) requirements India Pass Temporal (downward) Ellipse with axes ≥40 Field of vision field of vision ≥50° (EN 168) mm and ≥ 33mm (≥60°), respectively Transmittance of oculars > 74.4% Within limits for shade ≥ 85% or ≥ 78% (if Limits/method not directly without filtering action (EN 167) number 1.2 relaxed optics) comparable with EU/US ≤3% Haze n/a (ASTM D1003-13) Pass Increased robustness Pass (EN 168) Pass Pass Thermal stability n/a Similar limits/method as in EU (EN 168) (Clause 3 of IS 7524-1) Pass Pass Resistance to corrosion Pass As above (EN 168) (Clause 6 of IS 7524-1) Similar limits/method as in EU Pass Pass Requirement belongs to the Resistance to ignition Pass (EN 168) specific requirements category (Clause 8.1 of IS 7524-1) below but is listed here for ease of comparison Pass Suitability for disinfection n/a n/a An Indian requirement only (Clause 7 of IS 7524-1) Particular requirements Called “specific requirements” in     (per EU) India No color present for No color present for No color present for goggles goggles eye protectors Droplets and splashes of Testing in IS also covers fine Face shields pass the liquid Face shields pass the droplets area coverage area coverage (EN 168) (Clause 12 of IS 7524-1) Pass Not an explicit Lateral protection (optional) requirement for the Pass (EN 168) uses included Eye and face protection equipment meant to be used in health care settings are regulated as medical devices (Class A) in India; see 3.7.1. 187 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 9.3 Gloves 9.3.1 Medical examination gloves There are two Indian standards for medical examination gloves: IS 15354-1:2018 (for gloves made of rubber/ latex), identical to ISO 11193-1:2008 (now superseded by the 2020 edition) and IS 15354-2:2018 (for gloves made of PVC) which is identical to ISO 11193-2:2006. For details of the ISO standards, see 4.3.1.1. For completeness, it is mentioned that in 2021 ISO standards on protective gloves were adopted in India as the IS 6994 series. In particular, IS 6994-5:2021 “Protective gloves against dangerous chemicals and micro- organisms—Part 5: Terminology and performance requirements for micro-organisms risks,” is identical to ISO 374-5:2016 and IS 6994-7:2021, “Protective gloves—general requirements and test methods,” is identical to ISO 21420:2020. As mentioned in section 4.3.1.1 on EU and ISO requirements for medical examination gloves, standards on “protective gloves” (as opposed to “medical gloves”) will not be further detailed. Table 9.4 shows the requirements for medical examination gloves in the Indian market compared to those of the EU and US markets. Table 9.4: Comparison between EU, US, and Indian standards for medical examination gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.1 of this guide Color code: Green: Products made to the Indian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Indian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Indian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. US India ASTM—material specific EU Material specific (Market) D6319 (nitrile) EN 455 series IS 15354-1:2018 COMPARISON/COMMENTS standard D3578 (rubber) (rubber) D5250 (PVC) IS 15354-2:2018 (PVC) D6977 (polychloroprene) Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method AQL =1.5 AQL =2.5 AQL =2.5 Freedom from holes (EN 455-1:2020) (ASTM D5151) Non-thermoplastic AQL = 4.0 materials In the EU, instead of AQL, the ≥6.0N AQL = 4.0 Nitrile ≥ 14MPa/elongation median of 13 samples is used ≥400% For rubber ≥ 6.0 N Latex (natural) In general, the tensile properties Force at break (N) / ≥ 14MPa / and their limits specified in the Elongation ≥ 500% Indian standards are an amalgam Tensile strength (Type 1) and ≥ 400% Elongation ≥ 500% of the EU/US ones (MPa), elongation at (Type 2) break (%) Thermoplastic Polychloroprene materials (PVC, PE) ≥ 14MPa/elongation ≥ 400% (Also, after ageing/ Indian and EU standards specify For PVC challenge) ≥ 3.6N minimum absolute force (N) for ≥ 7.0 N PVC ≥ 11MPa/elongation ≥ Samples taken from the glove 300% Elongation ≥ 350% (varies with thickness); ASTM specifies in terms of tensile (EN 455-2 :2015, (ASTM D412, ASTM D573 strength method A of ISO (ageing)) 23529:2010) 188 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US India ASTM—material specific EU Material specific (Market) D6319 (nitrile) EN 455 series IS 15354-1:2018 COMPARISON/COMMENTS standard D3578 (rubber) (rubber) D5250 (PVC) IS 15354-2:2018 (PVC) D6977 (polychloroprene) Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method Pass (EN ISO 10993-5 No explicit Biocompatibility Pass (FDA regulations) and -10) requirements ≤ 2.0mg/glove (powder-free gloves) The requirement was first ≤ 2.0mg/glove Powder residue introduced in the 2020 edition of (EN 455-3, EN ISO n/a ≤ 10 mg/dm2 (powdered content ISO 11193-1 while IS 15354-1 is based 21171:2006) gloves) on the 2008 edition (ASTM D6124) ≤ 200 µg/dm2 “Manufacturer shall Aqueous soluble monitor the content Only for rubber gloves in natural rubber latex n/a protein content gloves and shall try to (ASTM D5712) minimize it” (EN 455-3) ≤ 10 µg/dm2 Extractable antigenic protein Optional n/a Only for rubber gloves content (ASTM D6499) If gloves are sterilized, EN 455-4 refers to Pass the nature of the EN ISO 11607 (sterile Sterility sterilization process (US Pharmacopeia) barrier integrity shall be disclosed on during shelf-life) request Medical examination gloves are regulated as medical devices (Class A) in India: see 3.7.1. 9.3.2 Surgical gloves IS 13422:1992 (reaffirmed 2018) is based on ASTM D3577-88 (the current edition is 2019). For details on the ASTM standard see 4.3.2.2. There is also IS 4148:1989 (reaffirmed 2017) on reusable surgical gloves. The main difference in the last standard is the testing of properties after autoclaving (for repeated sterilizations). Table 9.5 shows the requirements for surgical gloves in the Indian market (single-use only) compared to those of the EU and US markets. 189 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 9.5: Comparison between EU, US, and Indian standards for surgical gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.2.3 of this guide Color code: Green: Products made to the Indian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Indian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Indian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. US EU India (Market) ASTM D3577-19 EN 455 series IS 13422:1992 COMPARISON/COMMENTS standard Type 1: Natural rubber (reaffirmed 2018) Type 2: Synthetic rubber Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method *Note: Instead of AQL, IS 13422 specifies sample sizes and acceptance numbers for various Freedom from AQL = 0.65 Note* AQL = 1.5 lots holes (EN 455-1:2020) (ASTM D5151) Instead of watertightness (most commonly used today) IS 13422 specifies air tightness In the EU, instead of AQL, the median of 13 samples is used AQL = 4.0 Type 1: Latex (natural) ≥18MPa/elongation Type 1: Latex (natural) In general, the tensile properties Force at break (N) ≥560% ≥18MPa/elongation ≥560% and their limits specified in the All materials Indian standards are an amalgam Tensile strength of the EU/US ones (MPa), elongation ≥ 9.0N (%) Type 2: Synthetic rubber (EN 455-2 :2015, method ≥12Mpa/elongation ≥490% Type 2: Synthetic rubber (Also, after A of ISO 23529:2010) EU standards specify minimum ≥12Mpa/elongation ageing/challenge) absolute force (N) for samples ≥490% taken from the glove (varies (ASTM D412, ASTM D573 with thickness); ASTM and IS (ageing)) standards specify in terms of tensile strength (MPa—force per unit area) Pass No explicit Pass Biocompatibility (EN ISO 10993-5 and -10) requirements (FDA regulations) ≤ 2.0 mg/glove ≤ 2.0mg/glove Powder residue No explicit (EN 455-3, EN ISO content requirements (ASTM D6124) 21171:2006) “Manufacturer shall Aqueous soluble monitor the content in ≤ 200 µg/dm2 No explicit NRL gloves and shall try protein content requirements to minimize it” (EN 455-3, (ASTM D5712) Annex A) Extractable ≤ 10 µg/dm2 Optional No explicit antigenic protein content (EN 455-3, Annex B) requirements (ASTM D6499) EN 455-4 refers to EN Pass ISO 11607 (sterile barrier According to Indian Sterility (US Pharmacopeia) integrity during shelf- Pharmacopeia life) Surgical gloves are regulated as medical devices (Class B) in India; see 3.7.1. 190 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 9.4 Clothing 9.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) IS 17423:2020, “Medical textiles—coveralls for COVID-19—specification,” was developed rapidly to meet the urgent needs of the COVID-19 pandemic and had performance requirements only for blood resistance. It was revised in October 2021 and renamed “Medical textiles—bio-protective coveralls—specification,” while the 2020 edition may continue to be used for some time. The revised standard incorporates some characteristics of the standard for surgical gowns, IS 17334:2019, discussed in section 9.4.2. The scope of IS 17423 has been modified to include multiple use/reusable bio-protective coveralls. As for surgical gowns, four levels of performance are defined for bio-protective coveralls. Coveralls may or may not be supplied in a sterile package. In addition to IS 17423, there is also the standard IS 15071:2002 (reaffirmed 2014) on chemical protective clothing which is a largely design-oriented standard including protection Type 4 but not directly relatable to EN/ISO standards. This standard is not included in the comparison as it does not address protection against infective agents. Table 9.6 shows the requirements for protective clothing in the Indian market compared to those of the EU and US markets. Table 9.6: Comparison between EU, US, and Indian standards for protective clothing (bio-protective coveralls) Notes: • For a more detailed comparison of EU and US standards (including test methods), see 4.4.1 of this guide. • For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components, such as visors, are not included). • For protection against infective agents only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection— Type 4), Type 6 (limited protection against liquid chemicals) and Type PB [6] (partial-body protection—Type 6) Color code: Green: Products made to the Indian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Indian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Indian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. Market EU India US COMPARISON/ Requirement/testing Requirement/testing Requirement/testing COMMENTS Property method method method I. General EN ISO IS 17423:2021 NFPA 1999:2018 requirements 13688:2013+A1:2021 Levels 1 to 4 No harmful substances present Made from non-irritant Innocuousness No specific requirements material No azo dyes present 191 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU India US COMPARISON/ Requirement/testing Requirement/testing Requirement/testing COMMENTS Property method method method Acceptable (section 6.1) Meets manufacture Note: Design requirements requirements of only Clause 4 (coverall with integrated hood, shoe ≥650 g/(m224 h) covers, and so on) Note: In the US for single-use garments/ Acceptable Water vapor ensembles “moisture Design and transmission rate ≥1200 vapor transmission rate” is (Annex C) comfort g/(m224 h) for Levels 1 specified and 2 (section 8.28 and ASTM E96) ≥ 800 g/(m224 h) for ≥450 W/m2 Levels 3 and 4 Note: In the US, for multiple- use garments/ensembles (Annex F, IS 16390) “total heat loss test” is specified (section 8.32 and ASTM F1868) EN 14126:2003 & EN II. Protection 14605:2005+A1:2009 (for Types 4 and PB [4]) or EN No requirements in IS NFPA 1999:2018 against infective 13034:2005+A1:2009 (for agents Types 6 and PB [6]) 1. Materials requirements No requirements for a) Mechanical mechanical properties Abrasion resistance is Class 1 to 6 (highest) considered as a precondition Abrasion to barrier performance of (cl. 4.4 of EN 14325 & EN ISO n/a resistance materials 12947-2) (ASTM D4157) Class 1 to 6 (highest) Flex fatigue is considered Flex cracking as a precondition to barrier (cl. 4.5, 4.6 EN 14325 & EN n/a resistance performance of materials ISO 7854, method B) (ASTM F392) Single-use: “Tear-resistance test two” ≥17 N (section 8.38 and ASTM Class 1 to 6 (highest) D5733 for non-woven) Trapezoidal tear (EN 14325 & EN ISO 9073- n/a resistance Multiple-use: “Tear- 4:1997) resistance test one” ≥36 N (section 8.7 and ASTM D5587 for woven) ≥50 N ≥ 20 N for Levels 1 and 2 (section 8.4 and ASTM ≥ 40 N for Levels 3 and 4 D5034) Class 1 to 6 (highest) (both dry and wet) Tensile strength (cl. 4.9 of EN 14325 & EN Also bursting strength: (IS 15891 Part 3 for non- ISO 13934-1) ≥66N (single-use) woven, ≥222.5N (multiple-use) IS 1969 Part 1 for (section 8.5 and ASTM woven) D3787) ≥ 40 kPa for Level 1 to 4 ≥66N (single-use) (both dry and wet) ≥222.5N (multiple-use) Bursting strength was Bursting strength n/a (IS 1966 [Part 1]) (section 8.5 and ASTM eliminated in EU D3787) ≥12N (single-use) Class 1 to 6 (highest) Puncture ≥25N (multiple-use) (cl. 4.10 of EN 14325 and n/a resistance EN 863) (section 8.6 and ASTM D2572) No requirements for b) Chemical chemical resistance resistance properties 192 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU India US COMPARISON/ Requirement/testing Requirement/testing Requirement/testing COMMENTS Property method method method Permeation by Class 1 to 6 (highest) chemicals (EN ISO 6529, method A for n/a liquids) (applicable to Types 4 and PB [4]) Repellency to liquids In the US it is called “water- Class 1 to 3 (highest) ≤30% absorption resistance test”; n/a (section 8.31) (ISO 6530) it applies only to multiple- (applicable to use garments/ensembles Types 6 and PB[6]) Penetration by liquids Class 1 to 3 (highest) (applicable to n/a (ISO 6530) Types 6 and PB [6]) No requirements for c) Flammability flammability Resistance to Pass or min. class 1 (cl. Flame spread time ≥3.5 s ignition or flame 4.14 EN 14325 & EN 13274-4, n/a (section 8.39 and ASTM (more stringent) method 3) D1230) d) Penetration by infective agents Synthetic blood penetration resistance: Pass. Use procedure D of IS IS 16546 is identical to ISO 16546 (for pressure cycle 16603 up to 1.75 kPa for Level 1, Contaminated 3.5kPa for Level 2, 7 kPa Pass Note: Compared to the 2020 Class 1 to 6 (highest) for Level 3) Note: In the US the “bio- liquids under edition of IS 17423, testing (cl. 4.1.4.1 of EN 14126, ISO penetration test one” hydrostatic Viral penetration applies per IS 16545 (identical to 16603, and ISO 16604) pressure resistance: n/a for (section 8.3 and ASTM F1671) ISO 16604-bloodborne Levels 1 and 2, pass (for pathogens) is specified for pressure cycle up to 3.5 kPa for level 3, 7 kPa for Levels 3 and 4 Level 4). Use procedure D of IS 16545 Mechanical contact with Class 1 to 6 (highest) contaminated (cl. 4.1.4.2 of EN 14126 and n/a n/a liquids (wet EN ISO 22610) bacterial penetration) (Biologically) Class 1 to 3 (highest) contaminated n/a n/a (cl. 4.1.4.3 of EN 14126) liquid aerosols Contaminated n/a for Levels 1 and 2 As above solid particles log (CFU) < 1 for Levels 3 (cl. 4.1.4.4 of EN 14126 and n/a (dry microbial and 4 ISO 22612) penetration) (IS 16548) e) Other properties 193 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU India US COMPARISON/ Requirement/testing Requirement/testing Requirement/testing COMMENTS Property method method method Same limits/method as for surgical gowns Can be also supplied in sterile Cleanliness- ≤ 300 CFU/100 cm2 n/a n/a packaging (in which case, microbial (ISO 11737-1) the listed IS/ISO standards and Medical Device Rule, 2017 have to be followed) No cytotoxicity (IS/ISO 10993-5) Same limits/method as for Non-irritant and non- Biocompatibility n/a n/a surgical gowns sensitizer (IS/ISO 10993-10) 2. Whole-suit No requirements for requirements whole suits Pass Pass (EN ISO 17491-4 (method A) (section 8.2) Mist test (Type 6) n/a Note: In the US the “liquid as modified by cl. 5.2 of EN tight integrity test one” 13034) applies Pass Liquid spray test (cl. 4.3.4.2 etc. of EN Pass n/a (section 8.2) (Type 4) 14605 and EN ISO 17491-4 [method B]) Pass Demonstrate garment (EN 14605/EN 13034— functionality is included as Practical “seven movements” n/a part of the liquid integrity performance testing applied to garments sequence while wearing (ASTM F1154) the suit) 194 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 9.4.2 Gowns The relevant standard in India is IS 17334:2019, “Medical textiles—surgical gowns and surgical drapes— specification.” IS 17334 specifies characteristics from both the EN and US standards. In it, gowns of Level 0 to 3 are defined, roughly corresponding to Level 1 to 4 in the United States. Table 9.7 shows the requirements for gowns in the Indian market compared to those of the EU and US markets. Table 9.7: Comparison between EU, US, and Indian standards for gowns Note: For a more detailed comparison of EU and US standards (including test methods), see 4.4.2.3 of this guide. Color code: Green: Products made to the Indian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Indian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Indian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing methods are only mentioned separately when they are not defined in the product standard. US India EU ANSI/AAMI PB70:2012, ASTM (Market) IS 17334:2019 COMPARISON/ EN 13795-1:2019 F2407-20 (surgical gowns) standard Surgical gowns COMMENTS Surgical gowns and ASTM F3352-19 (isolation gowns) Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method ≤ 300 CFU (Level 1) Resistance to ≤ 300 CFU (less critical areas) ≤ 300 CFU (Level 2, for Similar limits/method as dry microbial less critical zones) n/a in EU penetration (EN ISO 22612:2005) (IS 16548) IB ≥ 2.8 (critical areas, standard performance) Resistance to IB = 6.0 (for critical zones), wet bacterial IB = 6.0 (critical areas, high Level 2 n/a penetration (IS 16549) performance) (EN ISO 22610:2006) Pass (Level 3) Additional “blood- IS 16546 (blood) Pass (AQL 4%, RQL=20%) Viral/blood resistance” test compared n/a (AAMI Level 4) penetration to US where only “viral Pass (Level 3) (ASTM F1671) resistance” is needed IS 16545 (viral) Cleanliness ≤ 300 CFU/100 cm2 ≤ 300 CFU/100 cm2 Same limits/method as microbial/ n/a (EN ISO 11737-1:2018) (ISO 11737-1) in EU bioburden Log10 (lint count) ≤ 4.0 Log10 (lint count) Limits same as in EU Particle release ≤ 4.0 Optional (method similar to EN ISO) (EN ISO 9073-10:2004) (IS 15891-10) ≥ 20 cm H2O (critical areas, standard ≥ 20 cm H2O ≥ 20 cm H2O performance) (Level 1) (AAMI Level 2) ≥ 100 cm H2O Water resistance ≥ 50 cm H2O ≥ 50 cm H2O Limits same as for the US (hydrostatic (critical areas, high pressure) (Level 2) (AAMI Level 3) (same method as in EU) performance) ≥ 10 cm H2O (ISO 811) (AQL 4%, RQL=20%) (AATC 127) (less critical areas) (EN ISO 811:2018) 195 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US India EU ANSI/AAMI PB70:2012, ASTM (Market) IS 17334:2019 COMPARISON/ EN 13795-1:2019 F2407-20 (surgical gowns) standard Surgical gowns COMMENTS Surgical gowns and ASTM F3352-19 (isolation gowns) Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method ≤ 4.5 g (AAMI Level 1) ≤ 4.5 g (Level 0) Water resistance ≤ 1.0 g (AAMI Levels 2 and 3) (impact n/a (ISO 16895) penetration) (AQL 4%, RQL=20%) (AATC 42 or NWSP 80.3) ≥ 40 kPa ≥ 40 kPa Bursting strength (both dry and wet) (dry) ≥ 40 kPa (critical areas) n/a Same limits as in the EU (wet) (EN ISO 13938:1:1999) (IS 1966 Part 1) ≥ 20 N ≥ 20 N Tensile strength (both dry and wet) (dry) ≥ 30 N ≥ 20 N (critical areas) (IS 15891 Part 3 for non- (ASTM D 5034) (EN 29073-3:1992) (wet) woven; IS 1969 Part 1 for woven) Pass Pass Pass Similar methodology as in Biocompatibility (IS/ISO 10993-5 (ANSI/ AAMI BE78 or ISO (EN ISO 10993-1:2009) EU/US IS/ISO 10993-10) 10993-10) Packaging for terminally For packaging and sterilized medical sterilization, the Medical Assurance level of sterilization Sterility devices is recommended Device Rule, 2017 shall be process: at least 10 -6 according to EN ISO 11607 followed series Manufacturer to provide Class 1 Flammability fire risk information (16 CFR 1610) Optional: - Water vapor transmission Other criteria to Comfort (depends on a consider variety of properties) Rate (ASTM D6701) - Evaporative resistance (ASTM F1868, Part B) 196 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 10 PRODUCT-SPECIFIC COMPARISONS (JORDAN) As indicated in section 3.8, some Jordanian standards are denominated as “technical standards” making their application mandatory (equivalent to “technical regulations”). 10.1 Masks 10.1.1 Respirators There is a Jordanian “technical (mandatory) standard,” JS 1937:2011, “Respiratory protective devices—valved filtering half-masks to protect against gases or gases and particles—requirement, testing, marking,” identical to EN 405:2001+A1:2009. However, this standard covers respirators other than the FFP class, which is typically used in situations where user protection in health care settings is desired. The applicable Jordanian standard, JS 1943:2011, “Respiratory protective devices-filtering half masks to protect against particles—requirements, testing and marking” is identical to EN 149:2001 (without the amendment A1 that was issued in the EU in 2009). Table 10.1 shows the requirements for respirators in the Jordanian market compared to those of the EU and US markets. Table 10.1: Comparison between EU, US, and Jordanian standards for respirators Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 of this guide Color code: Green: Products made to the Jordanian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Jordanian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Jordanian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US EU Jordan (Market) 42 CFR Part 84, EN 149:2001 +A1:2009, JS 1943:2011, COMPARISON/COMMENTS standard Series/Levels N95 and Classes FFP2 and FFP3 Classes FFP2 and FFP3 N99 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method Pass (based on two Pass (based two Fit testing before use Practical subjects performing subjects performing (required by OSHA, not performance various tasks) various tasks) NIOSH) 197 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US EU Jordan (Market) 42 CFR Part 84, EN 149:2001 +A1:2009, JS 1943:2011, COMPARISON/COMMENTS standard Series/Levels N95 and Classes FFP2 and FFP3 Classes FFP2 and FFP3 N99 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method FFP2 FFP2 ≤ 11% (individual) ≤ 11% (individual) Not specified ≤ 8% (mean) ≤ 8% (mean) Total inward leakage FFP3 FFP3 ≤ 5% (individual) ≤ 5% (individual) Not specified ≤ 2 % (mean) ≤ 2 % (mean) FFP2 N95 In Jordan, as in the EU, FFP2 ≥ 94% @ 95 L/min (NaCl ≥ 95% penetration of filtering material, ≥ 94% @ 95 L/min (NaCl and paraffin oil—EN @ 85 L/min (NaCl only) is specified (100%-filtering and paraffin oil) 13274-7) efficiency) There are some variations Filtering efficiency FFP3 between the JS 1943 and EN test FFP3 N99 ≥ 99% @ 95 L/min method requirements; the JS ≥ 99% @ 95 L/min ≥ 99% (NaCl and paraffin oil— requires testing according to EN (NaCl and paraffin oil) @ 85 L/min EN 13274-7) 143, while testing specified by (NaCl only) EN 149 (as amended in 2009) is according to EN 13274-7 Compatibility with Pass Pass n/a skin Flammability Pass Pass n/a Carbon dioxide Average ≤ 1% by volume Average ≤ 1% by volume n/a content in “dead space” in “dead space” Pass (in the practical Pass (in the practical Field of vision Pass performance test) performance test) FFP2 FFP2 N95 ≤ 70 Pa @ 30 L/min ≤ 70 Pa @ 30 L/min Breathing ≤ 343 Pa @ 85 L/min ≤ 240 Pa @ 95 L/min ≤ 240 Pa @ 95 L/min resistance FFP 3 FFP 3 (inhalation) N99 ≤ 100 Pa @ 30 L/min ≤ 100 Pa @ 30 L/min ≤ 343 Pa @ 85 L/min ≤ 300 Pa @ 95 L/min ≤ 300 Pa @ 95 L/min Breathing FFP2 and FFP3 FFP2 and FFP3 N95 and N99 resistance ≤ 300 Pa @160 L/min ≤ 300 Pa @160 L/min ≤ 245 Pa @ 85 L/min (exhalation) 198 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 10.1.2 Medical face masks The Jordanian technical standard for medical face masks is JS 1745:2007, “Disposable surgical masks- requirement and test methods.” The standard is based on EN 14683:2005 (since revised). There is also a draft technical standard, WD 115:2022, which will be aligned to the current EN 14683:2019. Additionally, two Jordanian standards that adopt ASTM testing methods for face masks exist: • JS 1753:2022 equivalent to ASTM F1862:2017 (splash resistance) • JS 1754:2022 equivalent to ASTM F2101:2019 (BFE testing method) Table 10.2 shows the requirements for medical face masks in the Jordanian market compared to those of the EU and US markets. Table 10.2: Comparison between EU, US and Jordanian standards for medical face masks Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.2 of this guide. Color code: Green: Products made to the Jordanian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Jordanian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Jordanian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. EU Jordan US (Market) EN 14683:2019 JS 1745:2007 ASTM F2100–21 COMPARISON/COMMENTS standard Types I, II and IIR Types I, II and IIR Levels 1, 2 and 3 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method Tensile strength of Only a requirement in Jordan n/a ≥20 N n/a strap (dimensional limits also apply) For adults: Other limits apply for young Width: 170 – 195 mm Dimensions n/a n/a children and children; additional Depth: 90 – 100 mm design requirements apply ≥ 95% (Types I) ≥ 95% (Type I) ≥ 95% (Level 1) Bacterial filtration ≥ 98% (Types II, IIR) ≥ 98% (Types II, IIR) ≥ 98% (Levels 2,3) Using efficiency (BFE) ASTM F2101 < 40 Pa/cm2 (Types < 40 Pa/cm (Types I, II) 2 <49 Pa/cm2 (Level 1) I, II) Differential < 60 Pa/cm2 (Type IIR) < 60 Pa/cm2 (Type <58.8 Pa/cm2 (Levels 2, 3) pressure IIR) (Tested at 8L/min (Tested at 8L/min Using EN 14683 flowrate) flowrate) Sub-micron ≥ 95 (Level 1) particulate filtration ≥ 98 (Levels 2,3) n/a n/a efficiency Both at 0.1 micron, using ASTM F2299 199 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets EU Jordan US (Market) EN 14683:2019 JS 1745:2007 ASTM F2100–21 COMPARISON/COMMENTS standard Types I, II and IIR Types I, II and IIR Levels 1, 2 and 3 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method ≥ 14.7 kPa (Level 1) Not required (Types I, II) Not required (Types ≥16 kPa (Level 2) I, II) Splash-resistance ≥ 16. 0 kPa (Type IIR) Using ISO 22609:2004 ≥21.4 kPa (Level 3) pressure ≥ 16 kPa (Type IIR) Using ISO 22609 Using ASTM F1862 Microbial ≤ 30 CFU/g ≤ 30 CFU/g n/a cleanliness Using EN ISO 11737-1:2018 Using ISO 11737-1 Pass Pass Pass Biocompatibility Using ISO EN 10993-1:2009 Using ISO 10993-1 Using ISO 10993-1 Class 1 Flame spread n/a n/a Using 16 CFR Part 1610 10.1.3 Community face coverings In Jordan, there is currently a normative document under development,64 FDJS 2339:2022, based on ASTM F3502-21 (for details on the ASTM standard, see 4.1.3.2). As a result, no comparison to EU or ASTM standards can be made at this time. 64 February 2022. Communication with JSMO. 200 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 10.2 Eye and face protection The relevant technical standard, JS 268:2008, “Personal eye protection—specifications,” is an identical adoption of EN 166 (for details, see 4.2.1). Table 10.3 shows the requirements for eye and face protection in the Jordanian market compared to those of the EU and US markets. Table 10.3: Comparison between EU, US, and Jordanian standards for eye and face protection Notes: • In general, requirements for lenses (only) have not been included. • For a more detailed comparison of EU and US standards (including test methods), see 4.2.1 of this guide. Color code: Green: Products made to the Jordanian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Jordanian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Jordanian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. Jordan (Market) EU US JS 268:2002 COMPARISON/COMMENTS standard EN 166:2001 ANSI/ISEA Z87.1:2020 Characteristic/ Requirement/ Requirement/ JS is an identical adoption of Requirement/testing method property testing method testing method EN 166 Construction and Pass Pass Pass materials (ANSI Z80.1) Headband Pass Pass n/a Basic (EU)/ fundamental (US)       requirements Pass Pass Field of vision (EN 168) (EN 168) Not a requirement, Not a requirement, Ellipse with axes ≥40 mm and ≥ Min. coverage area except for special except for special 33 mm uses uses Transmittance of > 74.4% > 74.4% oculars without filtering ≥ 85% (or ≥ 78% if relaxed optics) (EN 167) (EN 167) action ≤3% Haze n/a n/a (ASTM D1003-13) Pass Pass Increased robustness Pass (EN 168) (EN 168) Pass Pass Thermal stability n/a (EN 168) (EN 168) Pass Pass Resistance to corrosion Pass (EN 168) (EN 168) Pass Pass Resistance to ignition Pass (EN 168) (EN 168) Particular       requirements (EU) 201 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Jordan (Market) EU US JS 268:2002 COMPARISON/COMMENTS standard EN 166:2001 ANSI/ISEA Z87.1:2020 Characteristic/ Requirement/ Requirement/ JS is an identical adoption of Requirement/testing method property testing method testing method EN 166 No color present for No color present for goggles No color present for goggles goggles Droplets and splashes Face shields pass Face shields pass the area Face shields pass the of liquid the area coverage coverage test area coverage test test (EN 168) (EN 168) Lateral protection Pass Pass Pass (optional) (EN 168) (EN 168) Optional requirements (EU) Resistance to fogging Time without Time without Time without fogging ≥ 8 s (only for oculars, US requirement added in the fogging ≥ 8 s (EN fogging ≥ 8 s (EN not complete eye 168) 2020 edition 168) protectors) 10.3 Gloves 10.3.1 Medical examination gloves The relevant technical standards are the JS 809 series adopting the EN 455 series: • JS 809-1:2005 adopting EN 455-1:2000. “Medical gloves for single use—Part 1: requirements and testing for freedom from holes” (not the latest version) • JS 809-2:2014 adopting EN 455-2:2009, “Medical gloves for single use—Part 2: requirements and testing for physical properties” (not the latest version) • JS 809-3:2014 adopting EN 455-3:2006, “Medical gloves for single use—Part 3: requirements and testing for biological evaluation” (not the latest version) • JS 809-4:2014 adopting EN 455-4:2009, “Medical gloves for single use—Part 4: requirements and testing for shelf-life determination” (current) The Jordanian standards apply to surgical gloves and to medical examination gloves. This situation is true in the EU/UK as well, and it differs from the approach taken in ISO or ASTM standards where distinct standards apply for the two uses and different standards cover various materials of construction. Table 10.4 shows the requirements for medical examination gloves in the Jordanian market compared to those of the EU and US markets. 202 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 10.4: Comparison between EU, US, and Jordanian standards for medical examination gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.1 of this guide Color code: Green: Products made to the Jordanian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Jordanian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Jordanian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US ASTM—material specific (Market) EU Jordan D6319 (nitrile) COMPARISON/COMMENTS standard EN 455 series JS 809 series D3578 (rubber) D5250 (PVC) D6977 (polychloroprene) Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method AQL =1.5 AQL =1.5 AQL =2.5 Freedom from holes (EN 455-1:2020) (ASTM D5151) AQL = 4.0 Non-thermoplastic Non-thermoplastic materials materials Nitrile ≥ 14MPa/elongation ≥6.0N ≥6.0N ≥400% Latex (natural) Force at break (N) / ≥ 14MPa / Tensile strength Elongation ≥ 500% (MPa), elongation at break (%) Polychloroprene Thermoplastic ≥ 14MPa/elongation ≥ (Also, after ageing/ materials (PVC, PE) 400% challenge) Thermoplastic materials ≥ 3.6N (PVC, PE) PVC ≥ 11MPa/elongation ≥ ≥ 3.6N 300% (EN 455-2 :2015, method A of ISO (JS 809-2:2014, method (ASTM D412, ASTM D573 23529:2010) A of ISO 23529:2010) (ageing)) Pass (EN ISO 10993-5 Pass Biocompatibility Pass (FDA regulations) and -10) (ISO 10993-5 and -10) ≤ 2.0mg/glove ≤ 2.0mg/glove (powder- (EN 455-3, EN ISO free gloves) Powder residue 21171:2006) ≤ 2.0 mg/glove ≤ 10 mg/dm2 (powdered content gloves) (ASTM D6124) “Manufacturer shall ≤ 200 µg/dm2 Aqueous soluble monitor the content JS 809-3 is in line with the 2006 “ALARP” (as low as in natural rubber latex Only for rubber gloves. edition of EN 455-3 (was more protein content reasonably possible) gloves and shall try to stringent than current version) minimize it” (EN 455-3) (ASTM D5712) Extractable antigenic Optional ≤ 10 µg/dm2 Optional protein content (JS 809-3, Annex B) (EN 455-3, Annex B) (ASTM D6499) 203 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US ASTM—material specific (Market) EU Jordan D6319 (nitrile) COMPARISON/COMMENTS standard EN 455 series JS 809 series D3578 (rubber) D5250 (PVC) D6977 (polychloroprene) Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method EN 455-4 refers to JS 809-4 refers to ISO Pass EN ISO 11607 (sterile 11607 (sterile barrier Sterility barrier integrity integrity during shelf- (US Pharmacopeia) during shelf-life) life) 10.3.2 Surgical gloves As mentioned in section 10.3.1, surgical gloves in Jordan comply with the JS 809 series of technical standards, which also covers medical examination gloves. Table 10.5 shows the requirements for surgical gloves in the Jordanian market compared to those of the EU and US markets. Table 10.5: Comparison between EU, US, and Jordanian standards for surgical gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.2 of this guide. Color code: Green: Products made to the Jordanian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Jordanian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Jordanian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US EU Jordan (Market) ASTM D3577-19 EN 455 series JS 809 series COMPARISON/COMMENTS standard Type 1: Natural rubber Type 2: Synthetic Rubber Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method The 2020 edition of EN 455- AQL = 0.65 AQL = 1.5 Freedom from holes AQL = 1.5 1 has stricter AQL than JS (EN 455-1:2020) (ASTM D5151) 809-1 AQL = 4.0 Type 1: Latex (natural) Force at break (N) / ≥18MPa/elongation ≥560% All materials All materials Tensile strength (MPa), elongation ≥ 9.0N ≥ 9.0N (%) Type 2: Synthetic rubber (EN 455-2:2015, method A (JS 809-2, method A of ≥12Mpa/elongation ≥490% (Also, after ageing/ of ISO 23529:2010) ISO 23529:2010) challenge) (ASTM D412, ASTM D573 (ageing)) Pass Pass Pass Biocompatibility (EN ISO 10993-5 and -10) (ISO 10993-5 and -10) (FDA regulations) ≤ 2.0 mg/glove ≤ 2.0mg/glove Powder residue ≤ 2.0 mg/glove (EN 455-3, EN ISO content (JS 809-3) (ASTM D6124) 21171:2006) 204 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US EU Jordan (Market) ASTM D3577-19 EN 455 series JS 809 series COMPARISON/COMMENTS standard Type 1: Natural rubber Type 2: Synthetic Rubber Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method “Manufacturer shall ≤ 200 µg/dm2 JS 809-3 is in line with the Aqueous soluble monitor the content in “ALARP” (as low as 2006 edition of EN 455-3 NRL gloves and shall try (ASTM D5712) protein content reasonably possible) (was more stringent than to minimize it” (EN 455-3, current version) Annex A) Extractable ≤ 10 µg/dm2 Optional Optional antigenic protein content (EN 455-3, Annex B) (JS 809-3, Annex B) (ASTM D6499) JS 809-4 refers to ISO Pass EN 455-4 refers to EN 11607 (sterile barrier Sterility ISO 11607 (sterile barrier (US Pharmacopeia) integrity during shelf- integrity during shelf-life) life) 10.4 Clothing 10.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) The Jordanian technical standard that could be identified is JS 1899:2009, “Protective clothing for protection against chemicals—classification, labeling and performance requirements,” identical to ISO 16602:2007, since amended in 2012. No adoptions of ISO 13688, “Protective clothin­ g—general requirements,” or the EN series on chemical/infective agent protection (EN 14126, EN 14325, EN 13034, and EN 14605) were found. Similarly, the test method standards ISO 16603 (synthetic blood penetration) and ISO 16604 (bacteriophage method) have not been adopted. Table 10.6 shows the requirements for protective clothing in the Jordanian market compared to those of the EU and US markets. 205 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 10.6: Comparison between EU, US, and Jordanian standards for protective clothing Notes: For a more detailed comparison of EU and US standards (including test methods), see 4.4.1 of this guide. For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components, such as visors, are not included). For protection against infective agents only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection— Type 4), Type 6 (limited protection against liquid chemicals) and Type PB [6] (partial-body protection— Type 6). Color code: Green: Products made to the Jordanian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Jordanian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Jordanian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. Market EU Jordan US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ property testing method testing method testing method I. General EN ISO No No Jordanian standard could be NFPA 1999:2018 identified that is similar to ISO requirements 13688:2013+A1:2021 requirements 13688 (general requirements) No harmful substances present Innocuousness n/a No specific requirements No azo dyes present Acceptable (section 6.1) Note: Design requirements only ≥650 g/(m224 h) Note: In the US, for single-use Acceptable garments/ensembles “moisture vapor transmission rate” is Design & comfort (Annex C) n/a specified (section 8.28 and ASTM E96) ≥450 W/m2 Note: In the US for multiple-use garments/ensembles “total heat loss test” is specified (section 8.32 and ASTM F1868) JS 1899 (ISO 16602) is really about protective clothing against chemicals—not against infective agents Requirements EN 14126:2003 & EN 14605:2005+A1:2009 on mechanical properties and II. Protection chemical resistance of materials (for Type 4 and JS 1899:2009 NFPA 1999:2018 are included, as well as whole-suit against PB [4]) or EN requirements 13034:2005+A1:2009 infective agents (for Types 6 and PB [6]) No Jordanian standard could be identified similar to EN 14126 (protection against infective agents) 1. Materials requirements 206 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Jordan US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ property testing method testing method testing method a) Mechanical Class 1 to 6 (highest) Class 1 to 6 Abrasion resistance is considered Abrasion (highest) as a precondition to barrier EU/JS: Same limits/essentially (cl. 4.4 of EN 14325 & EN resistance performance of materials same method ISO 12947-2) (ISO 12947-2) (ASTM D4157) Class 1 to 6 (highest) Class 1 to 6 Flex fatigue is considered Flex cracking as a precondition to barrier (cl. 4.5, 4.6 EN 14325 and (highest) As above resistance (ISO 7854, performance of materials EN ISO 7854, method B) method B) (ASTM F392) Single-use: “Tear-resistance test two” ≥17 N Class 1 to 6 (section 8.38 and ASTM D5733 for Class 1 to 6 (highest) (highest) non-woven) Trapezoidal tear (EN 14325 & EN ISO 9073- As above resistance Multiple-use: “Tear-resistance 4:1997) (ISO 9073-4) test one” ≥36 N (Section 8.7 and ASTM D5587 for woven) Class 1 to 6 (highest) (ISO 13934-1) ≥50 N (section 8.4 and ASTM D5034) Class 1 to 6 (highest) In the JS/US there is also bursting Tensile strength (cl. 4.9 of EN 14325 & EN Bursting Also bursting strength: strength which was eliminated in strength: ≥66N (single-use) ISO 13934-1) the EU Class 1 to 6 ≥222.5N (multiple-use) (section 8.5 and ASTM D3787) (highest) (ISO 13938-1) Class 1 to 6 ≥12N (single-use) Class 1 to 6 (highest) Puncture (highest) (cl. 4.10 of EN 14325 & EN ≥25N (multiple-use) resistance 863) ISO 13996 (section 8.6 and ASTM D2572) b) Chemical resistance Class 1 to 6 Permeation by Class 1 to 6 (highest) (highest) chemicals (EN ISO 6529, method A (ISO 6529, (applicable to for liquids) method A for Types 4 and PB liquids) [4]) Repellency to JS 607 is identical to ISO 6530. liquids Class 1 to 3 ≤30% Class 1 to 3 (highest) In the US it is called “water- (highest) (section 8.31) (ISO 6530) absorption resistance test”; it (applicable to (JS 607) applies only to multiple-use Type 6 and PB [6]) garments/ensembles Penetration by liquids Class 1 to 3 Class 1 to 3 (highest) (applicable to (highest) (ISO 6530) Types 6 and PB (ISO 6530) [6]) c) Flammability Resistance to Pass or min. class 1 (cl. Pass or Min. Flame spread time ≥3.5 s Requirement has been eliminated ignition or flame 4.14 EN 14325 and EN class 1 (EN 13274- in ISO 16602 AMD1:2012 (not yet (more stringent) 13274-4, method 3) 4, method 3) (section 8.39 and ASTM D1230) adopted in JS) d) Penetration by infective agents 207 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Jordan US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ property testing method testing method testing method Contaminated Class 1 to 6 (highest) Pass liquids under Note: In the US the “bio- Requirement does not apply in JS (cl. 4.1.4.1 of EN 14126, ISO n/a hydrostatic penetration test one” applies 1899 16603 and ISO 16604) (section 8.3 and ASTM F1671) pressure Mechanical contact with Class 1 to 6 (highest) contaminated (cl. 4.1.4.2 of EN 14126 and n/a n/a liquids (wet EN ISO 22610) bacterial penetration) (Biologically) Class 1 to 3 (highest) contaminated n/a n/a (cl. 4.1.4.3 of EN 14126) liquid aerosols Contaminated As above solid particles (cl. 4.1.4.4 of EN 14126 n/a n/a (dry microbial and ISO 22612) penetration) 2. Whole-suit requirements Pass Pass Pass EU/JS: same limits/essentially (EN ISO 17491-4 (method (section 8.2) Mist test (Type 6) ISO 17491-4 A) as modified by cl. 5.2 Note: In the US the “liquid tight same method (method A) of EN 13034) integrity test one” applies Pass Liquid spray test (cl. 4.3.4.2 etc. of EN Pass Pass ISO 17491-4 (section 8.2) As above (Type 4) 14605 and EN ISO 17491-4 (method B) (method B)) Pass Demonstration of garment (EN 14605/EN Pass functionality is included as part of Practical 13034—”seven the liquid integrity testing applied As above performance JS 1899, Annex A to garments movements” sequence (ASTM F1154) while wearing the suit) 10.4.2 Gowns The relevant Jordanian technical standards for gowns are: • JS 983-1:2007, “Surgical drapes, gowns, and clean air suits, used as medical devices, for patients, clinical staff and equipment—Part 1: General requirements for manufacturers, processors, and products,” equivalent to EN 13795-1:2002 (since revised) • JS 983-2:2007, “Surgical drapes, gowns, and clean air suits, used as medical devices, for patients, clinical staff, and equipment­ —Part 2: Test methods,” equivalent to EN 13795-2:2002 (since revised and changed scope) • JS 983-3:2008, “Surgical drapes, gowns, and clean air suits, used as medical devices, for patients, clinical staff, and equipment—Part 3: Performance requirements and performance levels, equivalent to EN 13795- 3:2006 (since withdrawn). It is noted that the EN 13795 series of standards (originally consisting of three parts) was consolidated in a single standard, EN 13795, which was later separated again into two standards, EN 13795-1:2019 and EN 13795- 2:2019. The latest edition of EN 13795-1 contains both requirements and test methods for surgical drapes and gowns, while the latest EN 13795-2 deals only with clean air suits (which are outside the scope of this guide). For details on EN 13795-1:2019, the standard that is relevant to the scope of this guide, see 4.4.2.1. It is noted 208 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets that the alignment of JS 983 series to the current EN 13795 series is in progress.65 Table 10.7 shows the requirements for gowns in the Jordanian market compared to those of the EU and US markets. Table 10.7: Comparison between EU, US, and Jordanian standards for gowns Notes: For a more detailed comparison of EU and US standards (including test methods), see 4.4.2.3 of this guide. For simplicity, only requirements related to barrier performance of gown materials and seams are specified. Color code: Green: Products made to the Jordanian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Jordanian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Jordanian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US ANSI/AAMI Jordan PB70:2012 (all EU (Market) JS 983-1:2007 gowns) EN 13795-1:2019 COMPARISON/COMMENTS standard JS 983-3:2008 ASTM F2407-20 Surgical gowns Surgical gowns (surgical gowns) and ASTM F3352-19 (isolation gowns) JS 983-1 and -3 are adoptions of previous versions of EN 13795-1 Characteristic/ Requirement/testing Requirement/testing Requirement/testing and -3, containing only general property method method method and performance requirements, respectively JS 983-2 is an adoption of a previous version of EN 13795-2 containing only ≤ 300 CFU (less critical ≤ 300 CFU (less critical testing methods areas) areas) Limit in JS expressed as log10(CFU)≤2 Note: For critical Resistance to dry which is considered equivalent to ≤ product areas, wet n/a microbial penetration 300 CFU bacterial penetration limits apply instead AAMI PB 70 standard specifically EN ISO 22612:2005 EN ISO 22612 excludes dry microbial penetration from its scope IB ≥ 2.8 (critical IB ≥ 2.8 (critical areas, areas, standard standard performance) performance) US requires (only for Level 4) a stricter Resistance to wet IB = 6.0 (critical areas, n/a characteristic (viral penetration; see bacterial penetration IB = 6.0 (critical areas, high performance) next row in table) high performance) EN ISO 22610:2006 EN ISO 22610 Pass (AQL 4%, RQL=20%) Viral penetration n/a n/a (AAMI Level 4) ASTM F1671 Cleanliness microbial/ ≤ 300 CFU/100 cm ≤ 300 CFU/100 cm2 2 n/a bioburden EN ISO 11737-1:2018 EN 1174 series 65 February 2022. Communication with JSMO. 209 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US ANSI/AAMI Jordan PB70:2012 (all EU (Market) JS 983-1:2007 gowns) EN 13795-1:2019 COMPARISON/COMMENTS standard JS 983-3:2008 ASTM F2407-20 Surgical gowns Surgical gowns (surgical gowns) and ASTM F3352-19 (isolation gowns) JS 983-1 and -3 are adoptions of previous versions of EN 13795-1 Characteristic/ Requirement/testing Requirement/testing Requirement/testing and -3, containing only general property method method method and performance requirements, respectively Log10 (lint count) ≤ 4.0 Optional in the US Log10 (lint count) ≤ 4.0 Particle release IPM ≤3.5 In EN 13795-1, the Index for Particulate EN ISO 9073-10:2004 Matter (IPM) and the lint count have ISO 9073-10 been combined ≥ 20 cm H2O ≥ 20 cm H2O For critical areas/zones, US limits are (critical areas, std. (critical areas, std. the same as EU/Jordanian ones (for ≥ 20 cm H2O (AAMI performance) performance) Level 2) standard performance) or lower (for ≥ 100 cm H2O ≥ 100 cm H2O high performance) Water resistance ≥ 50 cm H2O (AAMI (critical areas, high (critical areas, high Limits in the US apply only to critical (hydrostatic pressure) performance) Level 3) performance) zone components (akin to critical (AQL 4%, RQL=20%) ≥ 10 cm H2O (less ≥ 10 cm H2O (less areas in the EU/Jordan) critical areas) critical areas) AATC 127 EU/Jordanian and US methods are EN ISO 811:2018 EN 20811 similar ≤ 4.5 g (AAMI Level 1) Limits in the US apply only to critical ≤ 1.0 g (AAMI Levels 2 zone components (akin to critical Water resistance and 3) n/a n/a areas in the EU/Jordan) (impact penetration) (AQL 4%, RQL=20%) AATC 42 or NWSP 80.3 ≥ 40 kPa ≥ 40 kPa Bursting strength (dry) ≥ 40 kPa (critical ≥ 40 kPa (critical areas) areas) (wet) EN ISO 13938-1:1999 EN ISO 13938-1 Higher limit in the US compared to ≥ 20 N ≥ 20 N the EU/Jordan Additionally, limits are Tensile strength (dry) ≥ 20 N (critical areas) ≥ 20 N (critical areas) ≥ 30 N set for tear strength (≥ 10 N per ASTM D5587 or D5733) and seam strength (wet) EN 29073-3:1992 EN 29073-3 ASTM D5034 ((≥ 30 N per ASTM D1683/D1683M) Physical property limits are same for all barrier levels per AAMI Pass Pass Biocompatibility n/a ANSI/AAMI BE78 or EN ISO 10993-1:2009 ISO 10993-10 Packaging for Validated terminally sterilized manufacturing Assurance level of medical devices Sterility and processing sterilization process: is recommended procedures shall be at least 10-6 according to EN ISO used 11607 series Manufacturer to Class 1 No explicit Flammability provide fire risk requirements information 16 CFR 1610 Optional: - Water vapor Comfort (depends on a Comfort (depends on transmission Rate Other criteria to variety of properties) a variety of properties) (ASTM D6701) consider - Evaporative resistance (ASTM F1868, Part B) - etc. 210 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 11 PRODUCT-SPECIFIC COMPARISONS (KENYA) 11.1 Masks 11.1.1 Respirators The relevant Kenyan standard, KS 2409-6:2018, “Health care wastes management commodities— —Part 6: Filtering face masks to protect against particles,” is based on EN 149:2001 (an specification­ amendment of which was issued in 2009). Table 11.1 shows the requirements for respirators in the Kenyan market compared to those of the EU and US markets. Table 11.1: Comparison between EU, US, and Kenyan standards for respirators Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 of this guide. Color code: Green: Products made to the Kenyan standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Kenyan standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Kenyan standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. EU US EN 149:2001 Kenya (Market) 42 CFR Part 84, +A1:2009 KS 2409-6:2018 COMPARISON/COMMENTS standard Series/Levels N95 and Classes FFP2 and Classes FFP2 and FFP3 N99 FFP3 Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method Pass (based on two Fit testing before use Practical Part of the leakage subjects performing (required by OSHA, not performance testing various tasks) NIOSH) FFP2 FFP2 ≤ 11% (individual) ≤ 11% (individual) Not specified Limit in KS is less strict than EN Total inward ≤ 8% (mean) (Annex C) leakage FFP3 FFP3 ≤ 5% (individual); ≤ 2% (individual) Not specified Limit in KS is stricter than EN ≤ 2 % (mean) (Annex C) 211 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets EU US EN 149:2001 Kenya (Market) 42 CFR Part 84, +A1:2009 KS 2409-6:2018 COMPARISON/COMMENTS standard Series/Levels N95 and Classes FFP2 and Classes FFP2 and FFP3 N99 FFP3 Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method FFP2 FFP2 N95 In Kenya, as in the EU, ≥ 94% @ 95 L/min ≥ 94% @ 95 L/min (NaCl ≥ 95% penetration of filtering material (NaCl and paraffin and paraffin oil) @ 85 L/min (NaCl only) is specified (100%-filtering oil—EN 13274-7) (Annex D) efficiency) Filtering Some variations exist between efficiency FFP3 FFP3 N99 KS 2409-6 and EN test method ≥ 99% @ 95 L/min ≥ 99% @ 95 L/min ≥ 99% requirements; KS 2409-6 requires (NaCl and paraffin (NaCl and paraffin oil) @ 85 L/min testing according to Annex D, oil—EN 13274-7) (Annex D) (NaCl only) while testing specified by EN 149 (2009) is according to EN 13274-7 Compatibility Pass n/a n/a with skin Pass Similar methodology, same Flammability Pass n/a (Annex E) requirement as in EU Average ≤ 1% by Carbon dioxide volume in “dead n/a n/a content space” Pass (in the practical Pass Field of vision Pass performance test) FFP2 FFP2 ≤ 70 Pa @ 30 L/min N95 Note 1: Limits in KS specified in ≤ 70 Pa @ 30 L/min ≤ 240 Pa @ 95 L/min ≤ 343 Pa @ 85 L/min mbar (1 mbar = 100 Pa) ≤ 240 Pa @ 95 L/min Note 1 Breathing (Annex F) resistance FFP 3 (inhalation) FFP 3 ≤ 100 Pa @ 30 L/min N99 ≤ 100 Pa @ 30 L/min ≤ 300 Pa @ 95 L/min ≤ 343 Pa @ 85 L/min ≤ 300 Pa @ 95 L/min Note 1 (Annex F) FFP2 and FFP3 Breathing FFP2 and FFP3 ≤ 300 Pa @160 L/min N95 and N99 resistance ≤ 300 Pa @160 L/min Note 1 ≤ 245 Pa @ 85 L/min (exhalation) (Annex F) 11.1.2 Medical face masks The Kenyan standard for medical face masks, KS 2636:2021, “Medical face masks-specification,” is similar to EN 14683 (for details, see 4.1.2.1), but it also contains some additional dimensional/design requirements. Table 11.2 shows the requirements for medical face masks in the Kenyan market compared to those of the EU and US markets. 212 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 11.2: Comparison between EU, US, and Kenyan standards for medical face masks Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.2 of this guide. Color code: Green: Products made to the Kenyan standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Kenyan standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Kenyan standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. EU Kenya US (Market) COMPARISON/ EN 14683:2019 KS 2636:2021 ASTM F2100–21 standard COMMENTS Types I, II and IIR Types I, II and IIR Levels 1, 2 and 3 Characteristic/ Requirement/ Requirement/ Requirement/ property Testing method Testing Method Testing method Only a requirement in Tensile strength of n/a ≥20 N n/a Kenya (dimensional limits strap also apply) Other limits apply for For adults: Width: 170–195 mm young children and Dimensions n/a n/a Depth: 90–100 mm children; additional design requirements apply ≥ 95% (Type I) ≥ 95% (Type I) ≥ 95% (Level 1) Bacterial filtration ≥ 98% (Types II, IIR) ≥ 98% (Types II, IIR) ≥ 98% (Levels 2,3) Using efficiency (BFE) ASTM F2101 < 40 Pa/cm2 (Types < 40 Pa/cm (Types I, II) 2 <49 Pa/cm2 (Level 1) I, II) < 60 Pa/cm2 (Type IIR) Differential pressure < 60 Pa/cm2 (Type <58.8 Pa/cm2 (Levels 2, 3) IIR) (Tested at 8L/min (Tested at 8L/min Using EN 14683 flowrate) flowrate) Sub-micron ≥ 95 (Level 1) particulate filtration ≥ 98 (Level 2,3) efficiency n/a n/a Both at 0.1 micron, using ASTM F2299 ≥ 15.7 kPa (Level 1) Not required (Types ≥16 kPa (Level 2) Not required (Types I, II) I, II) Splash-resistance ≥21.4 kPa (Level 3) pressure ≥ 16.0 kPa (Type IIR) ≥ 16 kPa (Type IIR) Using ISO 22609:2004 Using KS ISO 22609 Using ASTM F1862 Microbial ≤ 30 CFU/g ≤ 30 CFU/g n/a cleanliness Using EN ISO 11737-1:2018 Using KS ISO 11737-1 Pass Pass Pass Biocompatibility Using ISO EN 10993-1:2009 Using KS ISO 10993-1 Using ISO 10993-1 Class 1 Flame spread n/a n/a Using 16 CFR Part 1610 213 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 11.1.3 Community face coverings In Kenya, the standard KS 2924:2020, “Personal protective equipment—face masks—masks for public use— specification,” was developed. The standard makes reference to standards for medical face masks from Kenya, the EU, and the United States. Table 11.3 shows the requirements for community face coverings in the Kenyan market compared to those of the EU and US markets. Table 11.3: Comparison between EU, US, and Kenyan standards for community face coverings Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.3.3 of this guide. Color code: Green: Products made to the Kenyan standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Kenyan standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Kenyan standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. (Market) EU Kenya US COMPARISON/COMMENTS standard CWA 17553:2020 KS 2924:2020 ASTM F3502-21 Characteristic/ Requirement/testing Requirement/ Requirement/testing property method testing method method Breaking Only a requirement in Kenya (it appears strength of as a max. limit in the standard; apparently n/a ≥20 N n/a mask band at an error. Also, no details of the method are the joint provided) EN 14683:2019, Annex C Subpart K of 42 CFR (≤ 70 Pa/cm2) or Part 84, modified by For EU, either breathing resistance or Differential Breathing §8.2 air permeability is measured; stricter pressure ≤29.4 Pa/ resistance EN 13274-3 (inhalation limits for breathing resistance in Kenya cm2 resistance of 2.4 mbar; (Level 1 ≤ 15 mm H2O compared to the EU exhalation resistance 3 Level 2 ≤ 5 mm H2O) mbar) EN ISO 9237 Air permeability n/a n/a (≥ 96 l/s/m2 @ 100 Pa) EN 13274-7:2019 Subpart K of 42 CFR or ≥ 90% (salt Part 84, modified by §8.1 EN ISO 16890-2 OR Particle medium) EN ISO 21083-1:2018, For EU, either PFE or BFE is measured; for filtration ≥ 80% (oil medium) or measure BFE (see efficiency (PFE) PFE, the CEN Workshop Agreement (CWA) below) (Level 1 ≥20% provides for alternative methods (Level 90% ≥ 90% Level 2 ≥ 50%) Level 70% ≥ 70%) Particle size 3 (± 0.5) μm Manufacturer may Bacterial EN 14683:2019 filtration choose to provide the In Annex C of the KS, the apparatus efficiency (BFE) (Level 90% ≥ 90% n/a BFE results (as per of measuring BFE is used to measure ASTM F 2101) along with differential pressure Level 70% ≥ 70%) PFE Microbial ≤ 200 CFU/g Limits for specific bacteria/fungi also n/a n/a cleanliness Using KS ISO 11737-1 apply 214 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 11.2 Eye and face protection There are two relevant normative documents in Kenya: KS 2409-8:2018, “Health care wastes management commodities—specification—Part 8: Safety goggles,” and KPAS 2919:2020, “Personal protective equipment— face shield—specification.” The former standard makes reference to the relevant “particular requirements” of Clause 7.2 of KS ISO 4849, such as protection against chemical droplets. The corresponding ISO 4849 has been replaced by ISO 16321- 1:2021 (see 4.2.1. for details). The latter document, KPAS 2919:2020, “Personal protective equipment—face shield—specification,” was developed in response to the COVID-19 pandemic. This document provides the key requirements of a face shield but not a comprehensive list of requirements. Table 11.4 shows the requirements for eye and face protection in the Kenyan market, as incorporated in KPAS 2919, compared to those of the EU and US markets. Table 11.4: Comparison between EU, US, and Kenyan standards for eye and face protection Notes: • In general, requirements for lenses (only) have not been included. • For a more detailed comparison of EU and US standards (including test methods), see 4.2.1 of this guide. Color code: Green: Products made to the Kenyan standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Kenyan standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Kenyan standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. Kenya (Market) EU US COMPARISON/ KPAS 2919:2020 standard EN 166:2001 ANSI/ISEA Z87.1:2020 COMMENTS This specification only addresses face shields and only key requirements. Characteristic/ Requirement/ Requirement/ Requirement/testing method Safety goggles are property Testing method Testing Method addressed in KS 2409-08, based on a since replaced ISO standard Construction and Pass Pass Pass materials (ANSI Z80.1) Headband Pass Pass n/a Basic (EU)/ fundamental (US)       requirements Pass Field of vision n/a n/a (EN 168) Not a requirement, Ellipse with axes ≥40 Ellipse with axes ≥40 mm and ≥ Min. coverage area except for special mm and ≥ 33 mm 33 mm uses Transmittance of > 74.4% oculars without filtering n/a ≥ 85% (or ≥ 78% if relaxed optics) (EN 167) action ≤3% ≤3% Haze n/a (ASTM D1003-13) (ASTM D1003-13) 215 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Kenya (Market) EU US COMPARISON/ KPAS 2919:2020 standard EN 166:2001 ANSI/ISEA Z87.1:2020 COMMENTS This specification only addresses face shields and only key requirements. Characteristic/ Requirement/ Requirement/ Requirement/testing method Safety goggles are property Testing method Testing Method addressed in KS 2409-08, based on a since replaced ISO standard Pass Creased robustness n/a Pass (EN 168) Pass Thermal stability n/a n/a (EN 168) Pass Resistance to corrosion n/a Pass (EN 168) Pass Resistance to ignition n/a Pass (EN 168) Particular     requirements (EU) No color present for No color present for goggles goggles Droplets and splashes Face shields pass the area Face shields pass the No color present of liquid coverage test area coverage test (EN 168) Lateral protection Pass n/a Pass (optional) (EN 168) Optional requirements (EU) US requirement added in the 2020 edition Resistance to fogging Time without fogging ≥ 8 s In the Kenyan (only for oculars, Time without fogging n/a specification, test not complete eye ≥ 8 s (Acc to EN 168) methods are provided in protectors) Annex B (informative) but there is no requirement 11.3 Gloves 11.3.1 Medical examination gloves The relevant standards are KS ISO 11193-1:2020 (for gloves made of rubber/latex), identical to ISO 11193-1:2008 + AMD1:2012 (revised in 2020) and KS ISO 11193-2:2020 (made of PVC), identical to ISO 11193-2:2006 (current). For details on the ISO standards, see 4.3.1.1. For completeness, the normative document KNWA 2409-10:2012, “Health care wastes management commodities—Part 10: Gloves for health care waste handling—specifications,” is also mentioned. This document is related to the EN 374 series (since replaced by the EN ISO 374 series) for protective gloves. As it has been analyzed in part 4.3.1.1 on EU requirements for examination gloves, standards on “protective gloves” as opposed to “medical gloves” will not be further detailed. Table 11.5 shows the requirements for medical examination gloves in the Kenyan market compared to those of the EU and US markets. 216 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 11.5: Comparison between EU, US, and Kenyan standards for medical examination gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.1 of this guide. Color code: Green: Products made to the Kenyan standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Kenyan standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Kenyan standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US Kenya ASTM—material Material specific specific EU (Market) KS ISO 11193-1:2020 D6319 (nitrile) EN 455 series COMPARISON/COMMENTS standard (rubber) D3578 (rubber) KS ISO 11193- D5250 (PVC) 2:2006 (PVC) D6977 (polychloroprene) Requirement/ Requirement/ Requirement/testing Characteristic/property testing method testing method method AQL =1.5 AQL =2.5 AQL =2.5 Freedom from holes (EN 455-1:2020) (ASTM D5151) AQL = 4.0 Non-thermoplastic materials AQL = 4.0 Nitrile ≥ 14MPa/ In the EU, instead of AQL, the ≥6.0N median of 13 samples is used elongation ≥400% For rubber ≥ 6.0 N Latex (natural) In general, the tensile Elongation ≥ 500% ≥ 14MPa / properties and their limits (Type 1) and ≥ 400% Elongation ≥ 500% specified in the Kenyan Force at break (N) / standards are an amalgam of (Type 2) the EU/US ones Tensile strength (MPa), Polychloroprene elongation at break (%) Thermoplastic ≥ 14MPa/elongation ≥ materials (PVC, PE) (Also, after ageing/challenge) 400% Kenyan and EU standards ≥ 3.6N For PVC specify minimum absolute ≥ 7.0 N PVC ≥ 11MPa/ force (N) for samples taken elongation ≥ 300% from the glove (varies with Elongation ≥ 350% (EN 455-2 :2015, thickness); ASTM specifies in (ASTM D412, ASTM D573 terms of tensile strength method A of ISO [ageing]) 23529:2010) Pass (EN ISO 10993-5 No explicit Biocompatibility Pass (FDA regulations) and -10) requirements ≤ 2.0mg/glove The requirement was first (powder-free gloves) ≤ 2.0 mg/glove introduced in the 2020 edition Powder residue content (EN 455-3, EN ISO n/a ≤ 10 mg/dm (powdered of ISO 11193-1 while KS ISO 2 21171:2006) gloves) 11193-1 is based on the previous (ASTM D6124) edition ≤ 200 µg/dm2 “Manufacturer shall Aqueous soluble protein monitor the content Only for rubber gloves in natural rubber latex n/a content gloves and shall try to (ASTM D5712) minimize it” (EN 455-3) 217 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US Kenya ASTM—material Material specific specific EU (Market) KS ISO 11193-1:2020 D6319 (nitrile) EN 455 series COMPARISON/COMMENTS standard (rubber) D3578 (rubber) KS ISO 11193- D5250 (PVC) 2:2006 (PVC) D6977 (polychloroprene) Requirement/ Requirement/ Requirement/testing Characteristic/property testing method testing method method ≤ 10 µg/dm2 Extractable antigenic Optional n/a Only for rubber gloves protein content (ASTM D6499) If gloves are EN 455-4 refers to Pass sterilized, the nature EN ISO 11607 (sterile Sterility of the sterilization (US Pharmacopeia) barrier integrity process shall be during shelf-life) disclosed on request 11.3.2 Surgical gloves The relevant standard, KS ISO 10282:2014 is equivalent to ISO 10282:2014 (current; for details on the ISO standard, see 4.3.2.1). Table 11.6 shows the requirements for surgical gloves in the Kenyan market compared to those of the EU and US markets. Table 11.6: Comparison between EU, US, and Kenyan standards for surgical gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.2 of this guide. Color code: Green: Products made to the Kenyan standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Kenyan standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Kenyan standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. Kenya US (Market) KS ISO 10282:2014 EU ASTM D3577-19 standard Type 1: Natural rubber COMPARISON/COMMENTS EN 455 series Type 1: Natural rubber Type 2: Synthetic Type 2: Synthetic rubber rubber Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method Freedom from AQL = 0.65 AQL = 1.5 AQL = 1.5 holes (EN 455-1:2020) (ASTM D5151) AQL = 4.0 EU standard does not specify AQL AQL = 4.0 Force at break (N) Type 1: Latex (natural) Type 1: Latex (natural) All materials ≥18MPa/elongation ≥18MPa/elongation Tensile strength ≥560% EU standards specify minimum ≥560% (MPa), elongation ≥ 9.0N absolute force (N) for samples (%) Type 2: Synthetic rubber Type 2: Synthetic rubber taken from the glove (varies with (EN 455-2 :2015, method ≥12Mpa/elongation ≥12Mpa/elongation thickness); ASTM and Kenyan (Also, after A of ISO 23529:2010) ≥490% ≥490% standards specify in terms of ageing/challenge) tensile strength (MPa—force per (ASTM D412, ASTM D573 unit area) [ageing]) 218 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Kenya US (Market) KS ISO 10282:2014 EU ASTM D3577-19 standard Type 1: Natural rubber COMPARISON/COMMENTS EN 455 series Type 1: Natural rubber Type 2: Synthetic Type 2: Synthetic rubber rubber Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method Pass Pass Pass KS specifies generally similar Biocompatibility (EN ISO 10993-5 and -10) (FDA regulations) testing methodology with EU/US ≤ 2.0 mg/glove ≤ 2.0mg/glove Powder residue (EN 455-3, EN ISO n/a content (ASTM D6124) 21171:2006) “Manufacturer shall ≤ 200 µg/dm2 Aqueous soluble monitor the content in NRL gloves and shall try n/a (ASTM D5712) protein content to minimize it” (EN 455-3, Annex A) Extractable ≤ 10 µg/dm2 Optional antigenic protein n/a content (EN 455-3, Annex B) (ASTM D6499) Gloves shall be sterilized; the nature of Pass EN 455-4 refers to EN the sterilization process Sterility ISO 11607 (sterile barrier (US Pharmacopeia) shall be disclosed on integrity during shelf-life) request 11.4 Clothing 11.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) 11.4.1.1 Suits and coveralls The standards that could be identified are: • KS ISO 13688:2013, “Protective clothing—general requirements,” identical to ISO 13688:2013 (an amendment to the ISO standard was issued in 2021). KS ISO 13688:2013 only specifies general requirements about (any type of) protective clothing and it supplements standards with requirements for specific protection • KS 2409-07:2018, “Health care wastes management commodities—Part 7: Overall clothing — specification,” is also somewhat relevant, providing design and sizing requirements. It also specifies min. density of 250 g/m2 and seam strength requirements of 185 N for load bearing seams and 135 N for other seams, measured per KS ISO 3935-1. No Kenyan standard could be identified similar to EN 14126 (protection against infective agents). Table 11.7 shows the requirements for protective clothing in the Kenyan market (as expressed in KS ISO 13688:2013) compared to those of the EU and US markets. 219 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 11.7: Comparison between EU, US, and Kenyan standards for suits and coveralls Notes: • For a more detailed comparison of EU and US standards (including test methods), see 4.4.1 of this guide. • For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components, such as visors, are not included). • For protection against infective agents, only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection— Type 4), Type 6 (limited protection against liquid chemicals) and Type PB [6] (partial-body protection­ — Type 6) Color code: Green: Products made to the Kenyan standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Kenyan standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Kenyan standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. Market EU Kenya US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ property testing method testing method testing method No Kenyan standard could be I. General EN ISO identified similar to EN 14126 KS ISO 13688:2013 NFPA 1999:2018 requirements 13688:2013+A1:2021 (protection against infective agents) No harmful substances No harmful substances KS is identical to ISO 13688:2013 present Innocuousness present No specific requirements (without the amendment 1 No azo dyes present issued in 2021) No azo dyes present Acceptable (section 6.1) Note: Design requirements only ≥650 g/(m224 h) Note: In the US for single-use garments/ ensembles “moisture Acceptable vapor transmission rate” is Design and Acceptable Assessment (Annex C) specified comfort in Annex C (section 8.28 and ASTM E96) ≥450 W/m2 Note: In the US for multiple-use garments/ ensembles “total heat loss test” is specified (section 8.32 and ASTM F1868) EN 14126:2003 & EN II. Protection 14605:2005+A1:2009 (for Types 4 and PB [4]) or EN No requirements NFPA 1999:2018 against 13034:2005+A1:2009 (for infective agents Types 6 and PB [6]) 1. Materials requirements No requirements for a) Mechanical mechanical properties 220 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Kenya US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ property testing method testing method testing method Abrasion resistance Class 1 to 6 (highest) is considered as a Abrasion (cl. 4.4 of EN 14325 & EN ISO n/a precondition to barrier resistance performance of materials 12947-2) (ASTM D4157) Class 1 to 6 (highest) Flex fatigue is considered Flex cracking as a precondition to barrier (cl. 4.5, 4.6 EN 14325 & EN n/a resistance performance of materials ISO 7854, method B) (ASTM F392) Single-use: “Tear-resistance test two” ≥17 N (section 8.38 and ASTM Class 1 to 6 (highest) D5733 for non-woven) Trapezoidal tear (EN 14325 and EN ISO 9073- n/a resistance Multiple-use: “Tear- 4:1997) resistance test one” ≥36 N (Section 8.7 and ASTM D5587 for woven) ≥50 N (section 8.4 and ASTM D5034) Class 1 to 6 (highest) Bursting strength was Tensile strength (cl. 4.9 of EN 14325 and EN n/a Also bursting strength: ≥66N (single-use) eliminated in EU ISO 13934-1) ≥222.5N (multiple-use) (section 8.5 and ASTM D3787) ≥12N (single-use) Class 1 to 6 (highest) Puncture ≥25N (multiple-use) (cl. 4.10 of EN 14325 and EN n/a resistance 863) (section 8.6 and ASTM D2572) No requirements for b) Chemical chemical resistance resistance properties Permeation by Class 1 to 6 (highest) chemicals (EN ISO 6529, method A for (applicable to n/a liquids) Types 4 and PB [4]) Repellency to liquids In the US it is called “water- Class 1 to 3 (highest) ≤30% absorption resistance test”; it (applicable to n/a (section 8.31) (ISO 6530) applies only to multiple-use Types 6 and PB garments/ensembles [6]) Penetration by liquids Class 1 to 3 (highest) (applicable to n/a (ISO 6530) Types 6 and PB [6]) No requirements for c) Flammability flammability Resistance to Pass or min. class 1 (cl. 4.14 Flame spread time ≥3.5 s ignition or flame EN 14325 and EN 13274-4, n/a (section 8.39 and ASTM (more stringent) method 3) D1230) d) Penetration Requirement/testing by infective method agents 221 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Kenya US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ property testing method testing method testing method Pass Contaminated Class 1 to 6 (highest) Note: In the US the “bio- liquids under penetration test one” (cl. 4.1.4.1 of EN 14126, ISO n/a hydrostatic applies 16603 and ISO 16604) (section 8.3 and ASTM pressure F1671) Mechanical contact with Class 1 to 6 (highest) contaminated (cl. 4.1.4.2 of EN 14126 and n/a n/a liquids (wet EN ISO 22610) bacterial penetration) (Biologically) Class 1 to 3 (highest) contaminated n/a n/a (cl. 4.1.4.3 of EN 14126) liquid aerosols Contaminated As above solid particles (cl. 4.1.4.4 of EN 14126 and n/a n/a (dry microbial ISO 22612) penetration) 2. Whole-suit No requirements for requirements whole suits Pass Pass (section 8.2) (EN ISO 17491-4 (method A) Mist test (Type 6) n/a Note: In the US the “liquid as modified by cl. 5.2 of EN tight integrity test one” 13034) applies Pass Liquid spray test (cl. 4.3.4.2 etc. of EN 14605 Pass n/a (section 8.2) (Type 4) and EN ISO 17491-4 (method B)) Demonstration of garment Pass functionality is included Practical (EN 14605/EN 13034—”seven as part of the liquid n/a performance movements” sequence integrity testing applied to garments while wearing the suit) (ASTM F1154) 11.4.1.2 Partial-body garments A Kenyan standard for aprons was identified, KS 2409-3:2018, “Health care wastes management commodities—specification—Part 3: Plastic apron.” This standard sets requirements for PVC-coated aprons, among others, for density of materials, dimensions of the apron, and its straps and the strength of its straps. Table 11.8 shows the requirements for aprons in the Kenyan market compared to those of the EU and US markets. 222 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 11.8: Comparison between EU, US, and Kenyan standards for aprons Notes: • For a more detailed comparison of EU and US standards (including test methods), see 4.4.1 of this guide. • For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components, such as visors, are not included). • For protection against infective agents, only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection—Type 4), Type 6 (limited protection against liquid chemicals) and Type PB [6] (partial-body protection—Type 6). Color code: Green: Products made to the Kenyan standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Kenyan standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Kenyan standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. Market EU Kenya US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ property testing method testing method testing method No Kenyan standard could be I. General EN ISO identified similar to EN 14126 KS ISO 13688:2013 NFPA 1999:2018 requirements 13688:2013+A1:2021 (protection against infective agents) No harmful substances No harmful KS is identical to ISO present Innocuousness substances present No specific requirements 13688:2013 (without the No azo dyes present amendment 1 issued in 2021) No azo dyes present Acceptable (section 6.1) Note: Design requirements only ≥650 g/(m224 h) Note: In the US for single- Acceptable use garments/ensembles Design and Acceptable “moisture vapor transmission (Annex C) Assessment in Annex comfort rate” is specified C (section 8.28 and ASTM E96) ≥450 W/m2 Note: In the US for multiple- use garments/ensembles, “total heat loss test” is specified (section 8.32 and ASTM F1868) EN 14126:2003 & EN II. Protection 14605:2005+A1:2009 (for KS 2409-03:2018 Types 4 and PB [4]) or EN (plastic aprons NFPA 1999:2018 against infective 13034:2005+A1:2009 (for only) agents Types 6 and PB [6]) 1. Materials requirements a) Mechanical 223 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Kenya US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ property testing method testing method testing method Abrasion resistance is Class 1 to 6 (highest) considered as a precondition Abrasion (cl. 4.4 of EN 14325 & EN ISO n/a to barrier performance of resistance materials 12947-2) (ASTM D4157) Class 1 to 6 (highest) Flex fatigue is considered Flex cracking as a precondition to barrier (cl. 4.5, 4.6 EN 14325 and n/a resistance performance of materials EN ISO 7854, method B) (ASTM F392) Single-use: “Tear-resistance test two” ≥17 N Meets tear (section 8.38 and ASTM D5733 Note 1: KS 1148-2:1995 Class 1 to 6 (highest) requirements of for non-woven) Trapezoidal tear “Specification for fabrics for (EN 14325 & EN ISO 9073- KS 1148-2 resistance Multiple-use: “Tear-resistance water-resistant clothing—Part 4:1997) Note 1 test one” ≥36 N 2: PVC-coated fabrics” (section 8.7 and ASTM D5587 for woven) ≥50 N (section 8.4 and ASTM D5034) Class 1 to 6 (highest) Bursting strength was Tensile strength (cl. 4.9 of EN 14325 & EN n/a Also bursting strength: ≥66N (single-use) eliminated in EU ISO 13934-1) ≥222.5N (multiple-use) (section 8.5 and ASTM D3787) Density n/a ≥140 g/m2 n/a Only a Kenyan requirement Only a Kenyan requirement; Length: ≥ 900 mm there are also limits for length Dimensions n/a n/a Width: ≥750 mm of waist, shoulder or neck-loop straps ≥ 500 N Strap strength n/a (Annex A and ISO n/a Only a Kenyan requirement 13934-1) ≥12N (single-use) Class 1 to 6 (highest) Puncture (cl. 4.10 of EN 14325 & EN n/a ≥25N (multiple-use) resistance 863) (section 8.6 and ASTM D2572) No requirements for b) Chemical chemical resistance resistance properties Permeation by Class 1 to 6 (highest) chemicals (EN ISO 6529, method A for (applicable to n/a liquids) Types 4 and PB [4]) Repellency to liquids In the US it is called “water- Class 1 to 3 (highest) ≤30% absorption resistance test”; it (applicable to n/a (section 8.31) (ISO 6530) applies only to multiple-use Types 6 and PB garments/ensembles [6]) Penetration by Meets resistance to liquids corrosive elements Class 1 to 3 (highest) requirements of (applicable to (ISO 6530) KS 1148-2 Types 6 and PB [6]) Note 1 No requirements for c) Flammability flammability 224 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Kenya US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ property testing method testing method testing method Resistance to Pass or min. class 1 (cl. Flame spread time ≥ 3.5 s ignition or flame 4.14 EN 14325 & EN 13274-4, n/a (section 8.39 and ASTM (more stringent) method 3) D1230) d) Penetration Requirement/ by infective testing method agents Contaminated Class 1 to 6 (highest) Pass liquids under Note: In the US the “bio- (cl. 4.1.4.1 of EN 14126, ISO n/a hydrostatic penetration test one” applies 16603 and ISO 16604) (section 8.3 and ASTM F1671) pressure Mechanical contact with Class 1 to 6 (highest) contaminated (cl. 4.1.4.2 of EN 14126 and n/a n/a liquids (wet EN ISO 22610) bacterial penetration) (Biologically) Class 1 to 3 (highest) contaminated n/a n/a (cl. 4.1.4.3 of EN 14126) liquid aerosols Contaminated As above solid particles (cl. 4.1.4.4 of EN 14126 and n/a n/a (dry microbial ISO 22612) penetration) 2. Whole-suit No requirements for requirements whole suits Pass Pass (section 8.2) (EN ISO 17491-4 (method A) Mist test (Type 6) n/a Note: In the US the “liquid as modified by cl. 5.2 of EN tight integrity test one” 13034) applies Pass Liquid spray test Pass (cl. 4.3.4.2 etc. of EN n/a (section 8.2) (Type 4) 14605 and EN ISO 17491-4 (method B)) Pass Demonstration of garment (EN 14605/EN functionality is included as Practical 13034—”seven movements” n/a part of the liquid integrity performance testing applied to garments sequence while wearing (ASTM F1154) the suit) 11.4.2 Gowns No Kenyan standard for either surgical or isolation gowns could be identified, therefore no comparison table to EU/US standards can be provided. 225 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 12 PRODUCT-SPECIFIC COMPARISONS (MALAYSIA) 12.1 Masks 12.1.1 Respirators The applicable Malaysian standard, MS 2323:2010, “Respiratory protective devices—filtering half-masks to protect against particles—specification,” is identical to EN 149:2001 (without the amendment A1 that was issued in 2009). Table 12.1 shows the requirements for respirators in the Malaysian market compared to those of the EU and US markets. Table 12.1: Comparison between EU, US, and Malaysian standards for respirators Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 of this guide. Color code: Green: Products made to the Malaysian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Malaysian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Malaysian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. EU Malaysia US (Market) EN 149:2001 +A1:2009, MS 2323:2010, 42 CFR Part 84, COMPARISON/COMMENTS standard Classes FFP2 and FFP3 Classes FFP2 and FFP3 Series/Levels N95 and N99 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method Pass (based on two Pass (based on two Fit testing before use Practical subjects performing subjects performing (required by OSHA, not performance various tasks) various tasks) NIOSH) FFP2 FFP2 ≤ 11% (individual) ≤ 11% (individual) Not specified Total inward ≤ 8% (mean) ≤ 8% (mean) leakage FFP3 FFP3 ≤ 5% (individual) ≤ 5% (individual) Not specified ≤ 2 % (mean) ≤ 2 % (mean) 226 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets EU Malaysia US (Market) EN 149:2001 +A1:2009, MS 2323:2010, 42 CFR Part 84, COMPARISON/COMMENTS standard Classes FFP2 and FFP3 Classes FFP2 and FFP3 Series/Levels N95 and N99 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method FFP2 N95 In Malaysia, as in the EU, FFP2 ≥ 94% @ 95 L/min (NaCl ≥ 95% penetration of filtering material ≥ 94% @ 95 L/min (NaCl and paraffin oil—EN @ 85 L/min (NaCl only) is specified (100%-filtering and paraffin oil) 13274-7) efficiency). Filtering Some variations exist between FFP3 efficiency FFP3 N99 the MS 2323 and EN test method ≥ 99% @ 95 L/min ≥ 99% @ 95 L/min ≥ 99% requirements: MS 2323 requires (NaCl and paraffin oil— (NaCl and paraffin oil) @ 85 L/min testing according to EN 143, EN 13274-7) (NaCl only) while testing specified by EN 149 (2009) is according to EN 13274-7 Compatibility Pass Pass n/a with skin Flammability Pass Pass n/a Carbon dioxide Average ≤ 1% by volume Average ≤ 1% by volume n/a content in “dead space” in “dead space” Pass Pass (in the practical Field of vision (in the practical Pass performance test) performance test) FFP2 FFP2 N95 ≤ 70 Pa @ 30 L/min ≤ 70 Pa @ 30 L/min Breathing ≤ 343 Pa @ 85 L/min ≤ 240 Pa @ 95 L/min ≤ 240 Pa @ 95 L/min resistance FFP 3 FFP 3 (inhalation) N99 ≤ 100 Pa @ 30 L/min ≤ 100 Pa @ 30 L/min ≤ 343 Pa @ 85 L/min ≤ 300 Pa @ 95 L/min ≤ 300 Pa @ 95 L/min Breathing FFP2 and FFP3 FFP2 and FFP3 N95 and N99 resistance ≤ 300 Pa @160 L/min ≤ 300 Pa @160 L/min ≤ 245 Pa @ 85 L/min (exhalation) Respirators meant for health care settings are regulated as Class A medical devices in Malaysia; see section 3.10.3. 12.1.2 Medical face masks The current version of EN 14683:2019 is adopted in Malaysia as MS EN 14683:2021. For details on EN 14683, see 4.1.2.1. Table 12.2 shows the requirements for medical face masks in the Malaysian market compared to those of the EU and US markets. 227 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 12.2: Comparison between EU, US, and Malaysian standards for medical face masks Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.2 of this guide. Color code: Green: Products made to the Malaysian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Malaysian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Malaysian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. EU Malaysia US (Market) EN 14683:2019 MS EN 14683:2021 ASTM F2100 – 21 COMPARISON/COMMENTS standard Types I, II and IIR Types I, II and IIR Levels 1, 2 and 3 Characteristic/ Requirement/ Requirement/ Requirement/ Malaysian standard identical to property testing method testing method testing method current EN standard ≥ 95% (Type I) ≥ 95% (Type I) ≥ 95% (Level 1) Bacterial filtration ≥ 98% (Types II, IIR) ≥ 98% (Types II, IIR) ≥ 98% (Levels 2,3) Using efficiency (BFE) ASTM F2101 < 40 Pa/cm2 (Types < 40 Pa/cm2 (Types I, II) I, II) <49 Pa/cm2 (Level 1) Differential pressure < 60 Pa/cm2 < 60 Pa/cm2 (Type (Types IIR) IIR) <58.8 Pa/cm2 (Levels 2,3) (Tested at 8L/min (Tested at 8L/min flowrate) flowrate) Using EN 14683 ≥ 95 (Level 1) Sub-micron particulate filtration efficiency ≥ 98 (Levels 2,3) n/a n/a Both at 0.1 micron, using ASTM F2299 ≥ 10.7 kPa (Level 1) Not required (Types Not required (Types I, II) I, II) ≥16 kPa (Level 2) Splash-resistance ≥21.4 kPa (Level 3) pressure ≥ 16.0 kPa (Type IIR) ≥ 16.0 kPa (Type IIR) Using ISO 22609:2004 Using ISO 22609:2004 Using ASTM F1862 ≤ 30 CFU/g ≤ 30 CFU/g Microbial cleanliness n/a Using EN ISO 11737- Using EN ISO 11737- 1:2018 1:2018 Pass Pass Pass Biocompatibility Using ISO EN 10993- Using ISO EN 10993- Using ISO 10993-1 1:2009 1:2009 Class 1 Flame spread n/a n/a Using 16 CFR Part 1610 Medical face masks are regulated as Class A medical devices in Malaysia; see 3.10.3. 12.1.3 Community face coverings No standards for community face coverings have been identified in Malaysia, therefore no comparison table can be provided. The closest is a guidance document, “Effectiveness of fabric mask in the community,” published by the Malaysian Health Technology Assessment Section (MaHTAS) of the Ministry of Health in 228 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets June 2020, which specifies the following only: “Non-medical masks should consist of at least three layers of different material as follows: • An innermost layer of a hydrophilic material (for example, cotton or cotton blends) • An outermost layer made of hydrophobic material (for example, polypropylene, polyester, or their blends) which may limit external contamination from penetration through to the wearer’s nose and mouth • A middle hydrophobic layer of synthetic non-woven material such as polypropylene or a cotton layer which may enhance filtration or retain droplets.” A regulation is under development by the Ministry of Domestic Trade and Consumer Affairs, to be based on MS EN 14683.66 12.2 Eye and face protection No standards for eye and face protection in Malaysia have been identified. Therefore, no comparison table can be provided. 12.3 Gloves In Malaysia, as in the EU (and unlike the US or ISO), there are only standards for medical gloves for single-use and no separate standards for medical examination gloves and surgical gloves. Also, there are no separate standards depending on the material of manufacture. The following Malaysian standards are adoptions of EN standards: • MS 2299-1:2010, “Medical gloves for single-use—Part 1: Requirements and testing for freedom from holes” (EN 455-1:2000, revised in 2020) • MS 2299-3:2010, “Medical gloves for single-use­ —Part 3: Requirements and testing for biological evaluation” (EN 455-3:2006, revised in 2015). There are no Malaysian equivalents to the other two standards in the EN 455 series, that is, EN 455-2 (for physical properties) and EN 455-4 (for shelf-life). 12.3.1 Medical examination gloves Table 12.3 compares the (single) set of requirements for “medical gloves” in Malaysia with the EU and US requirements for medical examination gloves. 66 November 2021. Communication with Standards Malaysia. 229 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 12.3: Comparison between EU, US, and Malaysian standards for medical examination gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.1 of this guide. Color code: Green: Products made to the Malaysian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Malaysian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Malaysian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US ASTM—material specific (Market) EU Malaysia D6319 (nitrile) COMPARISON/COMMENTS standard EN 455 series MS 2299 (2010) series D3578 (rubber) D5250 (PVC) D6977 (polychloroprene) Characteristic/ Requirement/ Requirement/testing Requirement/testing Property testing method method method Freedom from AQL =1.5 AQL =1.5 AQL =2.5 holes (EN 455-1:2020) (ASTM D5151) Non-thermoplastic AQL = 4.0 materials Nitrile ≥ 14MPa/elongation ≥6.0N ≥400% Force at break (N) / Latex (natural) ≥ 14MPa / Tensile strength Elongation ≥ 500% (MPa), elongation Not clear if Malaysia references EN at break (%) Thermoplastic n/a 455-2 (or an ISO standard) regarding Polychloroprene materials (PVC, PE) ≥ 14MPa/elongation ≥ tensile properties ≥ 3.6N 400% (Also, after ageing/challenge) PVC ≥ 11MPa/elongation ≥ 300% (EN 455-2 :2015, (ASTM D412, ASTM D573 method A of ISO [ageing]) 23529:2010) Pass (EN ISO 10993-5 Pass Biocompatibility Pass (FDA regulations) and -10) (EN ISO 10993-5 and -10) ≤ 2.0mg/glove (powder- free gloves) Test methods MS 1459 and MS 1450 ≤ 2.0mg/glove Powder residue for powder-free and powdered (EN 455-3, EN ISO ≤ 2.0 mg/glove content ≤ 10 mg/dm2 (powdered gloves, respectively are based on a 21171:2006) gloves) superseded version of ASTM D6124 (ASTM D6124) “Manufacturer shall ≤ 200 µg/dm2 monitor the content This is in line with the 2006 edition Aqueous soluble in natural rubber “ALARP” (as low as Only for rubber gloves of EN 455-3 (was more stringent than protein content latex gloves and shall reasonably possible) try to minimize it” current version) (ASTM D5712) (EN 455-3) Extractable Optional ≤ 10 µg/dm2 Optional antigenic protein (EN 455-3, Annex B) content (EN 455-3, Annex B) (ASTM D6499) EN 455-4 refers to Pass It appears that EN 455-4 has not EN ISO 11607 (sterile been adopted in Malaysia Sterility (US Pharmacopeia) barrier integrity during shelf-life) Medical examination gloves are regulated as Class A medical devices in Malaysia (see 3.10.1). 230 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 12.3.2 Surgical gloves Table 12.4 compares the (single) set of requirements for “medical gloves” in Malaysia, with the EU and US requirements for surgical gloves. Table 12.4: Comparison between EU, US, and Malaysian standards for surgical gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.2 of this guide. Color code: Green: Products made to the Malaysian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Malaysian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Malaysian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US Malaysia EU ASTM D3577-19 (Market) MS 2299 (2010) EN 455 series Type 1: Natural rubber COMPARISON/COMMENTS standard series Type 2: Synthetic rubber Characteristic/ Requirement/testing Requirement/ Requirement/testing property method testing method method AQL = 0.65 AQL = 1.5 The 2020 edition of EN 455-1 Freedom from holes AQL = 1.5 (EN 455-1:2020) (ASTM D5151) has stricter AQL AQL = 4.0 Type 1: Latex (natural) ≥18MPa/elongation Force at break (N) / ≥560% All materials Tensile strength Not clear if Malaysia has (MPa), elongation ≥ 9.0N adopted EN 455-2 (or an ISO n/a (%) Type 2: Synthetic rubber standard) regarding tensile (EN 455-2 :2015, method A of ≥12Mpa/elongation properties (Also, after ageing/ ISO 23529:2010) ≥490% challenge) (ASTM D412, ASTM D573 (ageing)) Pass Pass Pass Biocompatibility (EN ISO 10993-5 and (EN ISO 10993-5 and -10) (FDA regulations) -10) Test methods MS 1459 and MS ≤ 2.0mg/glove 1450 for powder-free/powdered Powder residue ≤ 2.0 mg/glove ≤ 2.0 mg/glove gloves, respectively are based content (EN 455-3, EN ISO 21171:2006) (ASTM D6124) on a superseded version of ASTM D6124 “Manufacturer shall monitor ≤ 200 µg/dm2 Aqueous soluble This is in line with the 2006 the content in NRL gloves “ALARP” (as low as (ASTM D5712) edition of EN 455-3 (was more protein content and shall try to minimize it” reasonably possible) stringent than current version) (EN 455-3, Annex A) Extractable ≤ 10 µg/dm2 Optional Optional antigenic protein content (EN 455-3, Annex B) (EN 455-3, Annex B) (ASTM D6499) Pass EN 455-4 refers to EN It appears that EN 455-4 has Sterility ISO 11607 (sterile barrier (US Pharmacopeia) not been adopted in Malaysia integrity during shelf-life) Surgical gloves are regulated as Class A medical devices in Malaysia (see 3.10.1). 231 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 12.4 Clothing 12.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) MS ISO 13688:2020 is identical to the 2013 edition of ISO 13688 (an amendment to ISO 13688 was issued in 2021). The MS only specifies general requirements about (any type of) protective clothing and it supplements standards with requirements for specific protection. No MS could be identified similar to EN 14126 (protection against infective agents) but the latter seems to be accepted by the medical devices authority (MDA) in Malaysia. Table 12.5 shows the requirements for protective clothing in the Malaysian market compared to those of the EU and US markets. Table 12.5: Comparison between EU, US, and Malaysian standards for protective clothing Notes: • For a more detailed comparison of EU and US standards (including test methods), see 4.4.1 of this guide. • For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components, such as visors, are not included). • For protection against infective agents only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection—Type 4), Type 6 (limited protection against liquid chemicals) and Type PB [6] (partial-body protection—Type 6). Color code: Green: Products made to the Malaysian standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Malaysian standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Malaysian standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. Market EU Malaysia US COMPARISON/ Characteristic/ Requirement/testing Requirement/testing Requirement/testing COMMENTS property method method method I. General EN ISO 13688:2013+A1:2021 MS ISO 13688:2020 NFPA 1999:2018 requirements No harmful substances No harmful substances Similar to current ISO present present 13688+AMD 1 (MS contains Innocuousness fewer requirements, No azo dyes present No azo dyes present methods since revised) Acceptable (section 6.1) Note: Design requirements only ≥650 g/(m224 h) Note: In the US, for single-use garments/ ensembles “moisture Acceptable vapor transmission rate” is Similar to current ISO Acceptable Assessment Design and comfort (Annex C) specified in Annex C 13688+AMD 1 (section 8.28 and ASTM E96) ≥450 W/m2 Note: In the US, for multiple-use garments/ ensembles “total heat loss test” is specified (section 8.32 and ASTM F1868) 232 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Malaysia US COMPARISON/ Characteristic/ Requirement/testing Requirement/testing Requirement/testing COMMENTS property method method method EN 14126:2003 & EN II. Protection 14605:2005+A1:2009 (for against infective Types 4 and PB [4]) or EN NFPA 1999:2018 agents 13034:2005+A1:2009 (for Types 6 and PB [6]) 1. Materials requirements No requirements for a) Mechanical mechanical properties Abrasion resistance Class 1 to 6 (highest) is considered as a precondition to barrier Abrasion resistance (cl. 4.4 of EN 14325 & EN ISO n/a performance of materials 12947-2) (ASTM D4157) Flex fatigue is considered Class 1 to 6 (highest) as a precondition to Flex cracking (cl. 4.5, 4.6 EN 14325 and EN n/a barrier performance of resistance materials ISO 7854, method B) (ASTM F392) Single-use: “Tear- resistance test two” ≥17 N (section 8.38 and ASTM Class 1 to 6 (highest) D5733 for non-woven) Trapezoidal tear (EN 14325 and EN ISO 9073- n/a resistance Multiple-use: “Tear- 4:1997) resistance test one” ≥36 N (section 8.7 and ASTM D5587 for woven) ≥50 N (section 8.4 and ASTM D5034) Class 1 to 6 (highest) Bursting strength was Tensile strength (cl. 4.9 of EN 14325 and EN n/a Also bursting strength: ≥66N (single-use) eliminated in EU ISO 13934-1) ≥222.5N (multiple-use) (section 8.5 and ASTM D3787) ≥12N (single-use) Class 1 to 6 (highest) ≥25N (multiple-use) Puncture resistance (cl. 4.10 of EN 14325 and EN n/a 863) (section 8.6 and ASTM D2572) No requirements for b) Chemical chemical resistance resistance properties Class 1 to 6 (highest) Permeation by chemicals (EN ISO 6529, method A for n/a (applicable to Types liquids) 4 and PB [4]) Repellency to liquids In the US, it is called Class 1 to 3 (highest) ≤30% “water- absorption n/a (section 8.31) resistance test”; applies (applicable to Types (ISO 6530) only to multiple-use 6 and PB [6]) garments/ensembles Penetration by liquids Class 1 to 3 (highest) n/a (applicable to Types (ISO 6530) 6 and PB [6]) No requirements for c) Flammability flammability 233 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Malaysia US COMPARISON/ Characteristic/ Requirement/testing Requirement/testing Requirement/testing COMMENTS property method method method Resistance to Pass or min. class 1 (cl. 4.14 EN Flame spread time≥3.5 s ignition or flame 14325 and EN 13274-4, method n/a (section 8.39 and ASTM (more stringent) 3) D1230) d) Penetration by infective agents Pass ISO 16603 and ISO 16604 Contaminated Class 1 to 6 (highest) Note: In the US, the “bio- have both been adopted penetration test one” as Malaysian Standards. liquids under (cl. 4.1.4.1 of EN 14126, ISO n/a applies However, there is no MS hydrostatic pressure 16603 and ISO 16604) (section 8.3 and ASTM product standard referring F1671) to them Mechanical contact ISO 22610:2006 has been with contaminated Class 1 to 6 (highest) adopted as a Malaysian liquids (wet (cl. 4.1.4.2 of EN 14126 and EN n/a n/a Standard. However, there bacterial ISO 22610) is no MS product standard penetration) referring to it (Biologically) Class 1 to 3 (highest) contaminated liquid n/a n/a (cl. 4.1.4.3 of EN 14126) aerosols Contaminated ISO 22612:2006 has been As above adopted as a Malaysian solid particles (cl. 4.1.4.4 of EN 14126 and ISO n/a n/a Standard. However, there (dry microbial 22612) is no MS product standard penetration) referring to it 2. Whole-suit No requirements for requirements whole suits Pass Pass (EN ISO 17491-4 (method A) (section 8.2) Mist test (Type 6) n/a Note: In the US, the “liquid as modified by cl. 5.2 of EN tight integrity test one” 13034) applies Pass Liquid spray test (cl. 4.3.4.2 etc. of EN 14605 Pass n/a (section 8.2) (Type 4) and EN ISO 17491-4 [method B]) Demonstration of Pass garment functionality is Practical (EN 14605/EN 13034—“‘seven included as part of the n/a performance movements” sequence while liquid integrity testing applied to garments wearing the suit) (ASTM F1154) 12.4.2 Gowns No standards for medical gowns in Malaysia have been identified. Therefore, no comparison table can be provided. For international gown standards accepted in Malaysia, see 3.10.2. 234 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 13 PRODUCT-SPECIFIC COMPARISONS (SOUTH AFRICA) 13.1 Masks 13.1.1 Respirators The applicable South African standard (SANS), SANS 50149:2003, “Respiratory protective devices—filtering half-masks to protect against particles­ —requirements, testing, marking,” is identical to EN 149:2001 (without the amendment A1 that was issued in 2009). Several other EN standards on RPD have been adopted by the South African Bureau of Standards (SABS), such as SANS 50132 (EN 132—definition of terms and pictograms), SANS 50143 (EN 143—RPD-particle filters) and SANS 50133 (EN 133—classification of RPD). There is also a standalone national standard, SANS 10220:2010, “The selection, use, and maintenance of respiratory protective equipment.” Table 13.1 shows the requirements for respirators in the South African market compared to those of the EU and US markets. Table 13.1: Comparison between EU, US, and South African standards for respirators Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 of this guide. Color code: Green: Products made to the South African standard are likely to meet or exceed the EU or US standard Yellow: Products made to the South African standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the South African standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US EU South Africa (Market) 42 CFR Part 84, EN 149:2001 +A1:2009, SANS 50149:2003, COMPARISON/COMMENTS standard Series/Levels N95 and Classes FFP2 and FFP3 Classes FFP2 and FFP3 N99 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method Pass (based on two Pass (based on two Fit testing before use Practical subjects performing subjects performing (required by OSHA, not performance various tasks) various tasks) NIOSH) FFP2 FFP2 ≤ 11% (individual) ≤ 11% (individual) Not specified Total inward ≤ 8% (mean) ≤ 8% (mean) leakage FFP3 FFP3 ≤ 5% (individual) ≤ 5% (individual) Not specified ≤ 2 % (mean) ≤ 2 % (mean) 235 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US EU South Africa (Market) 42 CFR Part 84, EN 149:2001 +A1:2009, SANS 50149:2003, COMPARISON/COMMENTS standard Series/Levels N95 and Classes FFP2 and FFP3 Classes FFP2 and FFP3 N99 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method FFP2 N95 In South Africa, as in the EU, FFP2 ≥ 94% @ 95 L/min (NaCl ≥ 95% penetration of filtering material ≥ 94% @ 95 L/min and paraffin oil— @ 85 L/min (NaCl only) is specified (100%-filtering (NaCl and paraffin oil) EN 13274-7) efficiency); some variations exist between Filtering FFP3 the SANS 50149 and EN test efficiency FFP3 N99 ≥ 99% @ 95 L/min method requirements: SANS ≥ 99% @ 95 L/min ≥ 99% (NaCl and paraffin oil— 50149 requires testing according (NaCl and paraffin oil) @ 85 L/min EN 13274-7) to EN 143, while testing specified (NaCl only) by EN 149 (as amended in 2009) is according to EN 13274-7 Compatibility Pass Pass n/a with skin Flammability Pass Pass n/a Carbon dioxide Average ≤ 1% by volume Average ≤ 1% by volume n/a content in “dead space” in “dead space” Pass Pass Field of vision (in the practical (in the practical Pass performance test) performance test) FFP2 FFP2 N95 ≤ 70 Pa @ 30 L/min ≤ 70 Pa @ 30 L/min Breathing ≤ 343 Pa @ 85 L/min ≤ 240 Pa @ 95 L/min ≤ 240 Pa @ 95 L/min resistance FFP 3 FFP 3 (inhalation) N99 ≤ 100 Pa @ 30 L/min ≤ 100 Pa @ 30 L/min ≤ 343 Pa @ 85 L/min ≤ 300 Pa @ 95 L/min ≤ 300 Pa @ 95 L/min Breathing FFP2 and FFP3 FFP2 and FFP3 N95 and N99 resistance ≤ 300 Pa @160 L/min ≤ 300 Pa @160 L/min ≤ 245 Pa @ 85 L/min (exhalation) 13.1.2 Medical face masks In South Africa, the relevant standard is SANS 1866-1:2018, “Medical devices—Part 1: Medical face masks,” which draws heavily on the corresponding US standard, ASTM F2100, and the testing methods used in that standard. For completeness, it is mentioned that there is another part of the standard, SANS 1866-2: 2018, “Medical devices—Part 2: Medical respirators,” which addresses respirators used in health care settings, that is, devices offering increased protection to the persons wearing them. This standard is also based on US standards, that is, ASTM testing standards and 42 Code of Federal Regulations (CFR) Part 84. In SANS 1866- 2 essentially the same characteristics are specified as in SANS 1866-1 with the following main differences: there are stricter limits for filtration efficiency and splash resistance is not always required. Table 13.2 shows the requirements for medical face masks in the South African market (using only SANS 1866-1) compared to those of the EU and US markets. 236 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 13.2: Comparison between EU, US, and South African standards for medical face masks Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 and 4.1.2 of this guide. Color code: Green: Products made to the South African standard are likely to meet or exceed the EU or US standard Yellow: Products made to the South African standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the South African standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. EU South Africa US (Market) EN 14683:2019 SANS 1866-1 ASTM F2100–21 COMPARISON/COMMENTS standard Types I, II and IIR Levels 1, 2 and 3 Levels 1, 2 and 3 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method ≥ 95% (Type I) ≥ 95% (Level 1) ≥ 95% (Level 1) Bacterial filtration ≥ 98% (Level 2,3) In the SANS, both EN and US ≥ 98% (Levels 2,3) efficiency (BFE) methods for BFE are acceptable ≥ 98% (Types II, IIR) Using EN 14683 or ASTM Using ASTM F2101 F2101 < 40 Pa/cm2 <39 Pa/cm2 (Level 1) In the SANS, both EN and US <49 Pa/cm2 (Level 1) (Type I, II) methods for breathing resistance <58.8 Pa/cm2 (differential pressure) are Differential pressure <58.8 Pa/cm2 < 60 Pa/cm2 (Levels 2, 3) Note 1 acceptable (Levels 2,3) (Type IIR) Using EN 14683 or ASTM Note 1: Limits in SANS specified Using EN 14683 (Tested at 8L/min F2100 as 4.0 and 5.0 mm H2O/cm2, flowrate) respectively ≥ 95% (Level 1) ≥ 95% (Level 1) Sub-micron particulate filtration ≥ 98% (Levels 2,3) ≥ 98% (Levels 2,3) n/a efficiency Both at 0.1 micron, Both at 0.1 micron, using ASTM F2299 using ASTM F2299 ≥ 10.7 kPa (Level 1) ≥ 10.7 kPa (Level 1) Not required (Types I, II) ≥16 kPa (Level 2) ≥16 kPa (Level 2) Note 2: Limits in SANS specified Splash-resistance as 80, 120 and 160 mm Hg, pressure ≥ 16.0 kPa (Type IIR) ≥21.4 kPa (Level 3) ≥21.4 kPa (Level 3) respectively Using ISO 22609:2004 Note 2 Using ASTM F1862 Using ASTM F1862 ≤ 30 CFU/g Microbial cleanliness Using EN ISO 11737- n/a n/a 1:2018 Pass Pass Biocompatibility Using ISO EN 10993- n/a Using ISO 10993-1 1:2009 SANS 50149 and 16 CFR Class 1 Flame spread n/a 1610 Using 16 CFR Part 1610 Validated sterilization Validated sterilization Sterility process (optional n/a process (optional requirement) requirement) 13.1.3 Community face coverings There is not yet a relevant standard for community face coverings in South Africa. SANS 2065, “General use face mask—fabric type,” is under development.67 67 January 2022. Communication with SABS. 237 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 13.2 Eye and face protection The relevant standard, SANS 50166, is an identical adoption of EN 166 (for details, see 4.2.1). Similarly, testing method standards SANS 50167 (for optical test methods) and SANS 50168 (for non-optical test methods) are identical adoptions of EN 167 and EN 168, correspondingly. There is also SANS 1404:2009, “Eye protectors for industrial and non-industrial use,” which contains similar requirements with SANS 50166, such as tests for protection against liquid droplets or liquid splashes. Table 13.3 shows the requirements for eye and face protection in the South African market, based on SAN 50166, compared to those of the EU and US markets. Table 13.3: Comparison between EU, US, and South African standards for eye and face protection Notes: • In general, requirements for lenses (only) have not been included. • For a more detailed comparison of EU and US standards (including test methods), see 4.2.1 of this guide. Color code: Green: Products made to the South African standard are likely to meet or exceed the EU or US standard Yellow: Products made to the South African standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the South African standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. South Africa (Market) EU US COMPARISON/ SANS 50166:2018 standard EN 166:2001 ANSI/ISEA Z87.1:2020 COMMENTS SANS 50166 is an Requirement/testing Requirement/ Characteristic/property Requirement/testing method identical adoption of method testing method EN 166 Construction and Pass Pass Pass materials (ANSI Z80.1) Headband Pass Pass n/a Basic (EU)/fundamental       (US) requirements Pass Pass Field of vision (EN 168) (SANS 50168) Not a requirement, Not a requirement, Ellipse with axes ≥40 mm and ≥ Min. coverage area except for special except for special uses 33 mm uses Transmittance of oculars > 74.4% > 74.4% ≥ 85% (or ≥ 78% if relaxed optics) without filtering action (EN 167) (SANS 50167) ≤3% Haze n/a n/a (ASTM D1003-13) Pass Pass Increased robustness Pass (EN 168) (SANS 50168) Pass Pass Thermal stability n/a (EN 168) (SANS 50168) Pass Pass Resistance to corrosion Pass (EN 168) (SANS 50168) Pass Pass Resistance to ignition Pass (EN 168) (SANS 50168) 238 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets South Africa (Market) EU US COMPARISON/ SANS 50166:2018 standard EN 166:2001 ANSI/ISEA Z87.1:2020 COMMENTS SANS 50166 is an Requirement/testing Requirement/ Characteristic/property Requirement/testing method identical adoption of method testing method EN 166 Particular requirements       (EU) No color present for No color present for No color present for goggles goggles goggles Droplets and splashes of Face shields pass the area Face shields pass the Face shields pass the liquid coverage test area coverage test area coverage test (EN 168) (SANS 50168) Lateral protection Pass Pass Pass (optional) (EN 168) (SANS 50168) Optional requirements (EU) Resistance to fogging Time without fogging ≥ Time without Time without fogging ≥ 8 s US requirement added in (only for oculars, not fogging ≥ 8 s (SANS 8 s (EN 168) 50168) the 2020 edition complete eye protectors) 13.3 Gloves 13.3.1 Medical examination gloves The relevant standard is SANS 11193-1:2010 (for gloves made of rubber/latex), identical to ISO 11193-1:2008 (last revised in 2020). There appears not to be a corresponding standard for gloves made of PVC, for example, an adoption of ISO 11193-2. For details on the ISO standards, see 4.3.1.1. Also, there is SANS 50455 series of standards, adopting the EN 455 series as follows: • SANS 50455-1:2019 adopting EN 455-1:2000, “Medical gloves for single-use—Part 1: Requirements and testing for freedom from holes” (not the latest version) • SANS 50455-2:2019 adopting EN 455-2:2015, “Medical gloves for single-use—Part 2: Requirements and testing for physical properties” (current) • SANS 50455-3:2019 adopting EN 455-3:2015, “Medical gloves for single-use—Part 3: Requirements and testing for biological evaluation” (current) • SANS 50455-4:2019 adopting EN 455-4:2009, “Medical gloves for single-use—Part 4: Requirements and testing for shelf-life determination” (current). These South African standards apply to both surgical gloves and medical examination gloves. This situation is true in the EU/UK as well, while it differs from the approach taken in ISO or ASTM standards, where distinct standards apply for the two uses and different standards cover various materials of construction. For completeness, the standalone SANS 416:2021, “Chemical resistant gloves,” is also mentioned but it will not be further detailed. Table 13.4 shows the requirements for medical examination gloves in the South African market, based only on SANS 11193-1, compared to those of the EU and US markets. 239 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 13.4: Comparison between EU, US, and South African standards for medical examination gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.1.3 of this guide. Color code: Green: Products made to the South African standard are likely to meet or exceed the EU or US standard Yellow: Products made to the South African standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the South African standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US South Africa ASTM—material specific EU Material specific (Market) D6319 (nitrile) EN 455 series SANS 11193-1:2010 COMPARISON/COMMENTS standard D3578 (rubber) (rubber) D5250 (PVC) D6977 (polychloroprene) Characteristic/ Requirement/ Requirement/testing Requirement/testing SANS 11193-1:2010 is an adoption of property testing method method method ISO 11193-1:2008 (since revised) Freedom from AQL =1.5 AQL =2.5 AQL =2.5 holes (EN 455-1:2020) (ASTM D5151) AQL = 4.0 Non-thermoplastic materials Nitrile ≥ 14MPa/ ≥6.0N elongation ≥400% In the EU, instead of AQL, the median of 13 samples is used AQL = 4.0 Latex (natural) Force at break ≥ 14MPa / (N) / For rubber In general, the tensile properties Elongation ≥ 500% and their limits specified in the Tensile strength ≥ 6.0 N Indian standards are an amalgam (MPa), elongation of the EU/US ones at break (%) Elongation ≥ 500% (Type 1) Polychloroprene Thermoplastic and ≥ 400% (Type 2) ≥ 14MPa/elongation ≥ materials (PVC, PE) (Also, after 400% SANS and EN standards specify ≥ 3.6N ageing/challenge) minimum absolute force (N) for PVC ≥ 11MPa/elongation samples taken from the glove (varies with thickness); ASTM ≥ 300% specifies in terms of tensile (EN 455-2 :2015, strength (ASTM D412, ASTM D573 method A of ISO [ageing]) 23529:2010) Pass (EN ISO 10993-5 Biocompatibility No explicit requirements Pass (FDA regulations) and -10) ≤ 2.0mg/glove (powder- free gloves) The requirement was first Powder residue ≤ 2.0mg/glove (EN 455- n/a ≤ 10 mg/dm (powdered 2 introduced in the 2020 edition of content 3, EN ISO 21171:2006) gloves) ISO 11193-1 (ASTM D6124) ≤ 200 µg/dm2 “Manufacturer shall Aqueous soluble monitor the content Only for rubber gloves in natural rubber latex n/a protein content gloves and shall try to (ASTM D5712) minimize it” (EN 455-3) 240 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US South Africa ASTM—material specific EU Material specific (Market) D6319 (nitrile) EN 455 series SANS 11193-1:2010 COMPARISON/COMMENTS standard D3578 (rubber) (rubber) D5250 (PVC) D6977 (polychloroprene) Characteristic/ Requirement/ Requirement/testing Requirement/testing SANS 11193-1:2010 is an adoption of property testing method method method ISO 11193-1:2008 (since revised) ≤ 10 µg/dm2 Extractable antigenic protein Optional n/a Only for rubber gloves content (ASTM D6499) EN 455-4 refers to If gloves are sterilized, the Pass EN ISO 11607 (sterile nature of the sterilization Sterility (US Pharmacopeia) barrier integrity during process shall be disclosed shelf-life) on request 13.3.2 Surgical gloves The relevant standard, SANS 68:2003, is equivalent to ISO 10282:2002, though there is a later (2014) version of ISO 10282 (a minor revision; for details on the ISO standard, see 4.3.2.1). Table 13.5 shows the requirements for surgical gloves in the South African market compared to those of the EU and US markets. Table 13.5: Comparison between EU, US, and South African standards for surgical gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.2.3 of this guide Color code: Green: Products made to the South African standard are likely to meet or exceed the EU or US standard Yellow: Products made to the South African standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the South African standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US South Africa ASTM D3577-19 (Market) SANS 68:2003 EU Type 1: Natural standard Type 1: Natural rubber COMPARISON/COMMENTS EN 455 series rubber Type 2: Synthetic Type 2: Synthetic rubber rubber Characteristic/ Requirement/testing Requirement/testing Requirement/ property method method testing method Freedom from AQL = 0.65 AQL = 1.5 AQL = 1.5 holes (EN 455-1:2020) (ASTM D5151) AQL = 4.0 AQL = 4.0 EU standard does not specify AQL Force at break (N) Type 1: Latex Type 1: Latex (natural) All materials (natural) ≥18MPa/ ≥18MPa/elongation Tensile strength elongation ≥560% ≥560% EU standards specify minimum absolute (MPa), elongation ≥ 9.0N (%) Type 2: Synthetic force (N) for samples taken from the (EN 455-2 :2015, method Type 2: Synthetic rubber ≥12Mpa/ glove (varies with thickness); ASTM (Also, after A of ISO 23529:2010) rubber ≥12Mpa/ and SANS standards specify in terms of elongation ≥490% ageing/challenge) elongation ≥490% tensile strength (MPa—force per unit (ASTM D412, ASTM area) D573 (ageing)) 241 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US South Africa ASTM D3577-19 (Market) SANS 68:2003 EU Type 1: Natural standard Type 1: Natural rubber COMPARISON/COMMENTS EN 455 series rubber Type 2: Synthetic Type 2: Synthetic rubber rubber Characteristic/ Requirement/testing Requirement/testing Requirement/ property method method testing method Pass Pass Pass SANS specifies generally similar testing Biocompatibility (EN ISO 10993-5 and -10) (FDA regulations) methodology with EU/US ≤ 2.0 mg/glove ≤ 2.0mg/glove Powder residue (EN 455-3, EN ISO n/a content (ASTM D6124) 21171:2006) “Manufacturer shall ≤ 200 µg/dm2 Aqueous soluble monitor the content in NRL gloves and shall try n/a (ASTM D5712) protein content to minimize it” (EN 455-3, Annex A) Extractable ≤ 10 µg/dm2 Optional antigenic n/a protein content (EN 455-3, Annex B) (ASTM D6499) Gloves shall be EN 455-4 refers to EN Pass sterilized; the nature ISO 11607 (sterile barrier of the sterilization Sterility (US Pharmacopeia) integrity during shelf- process shall be disclosed on request life) 13.4 Clothing 13.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) The following standards were identified: • SANS 434:2018, “General protective clothing,” includes requirements on materials, workmanship, size, and make of various types of suits, coats, and overalls. This will not be further analyzed as the regulatory agency SAHPRA references compliance to ISO 13688:2013,68 “Protective clothing—general requirements” (not yet adopted in South Africa) • SANS 54325:2019, “Protective clothing against chemicals—test methods and performance classification of chemical protective clothing materials, seams, joins, and assemblages” is an adoption of EN 14325:2018 (current). On the other hand, EN 14126, the standard for protection against infective agents and which makes reference to EN 14325, has not been adopted in South Africa. As a result of the above, no comparison between South African and EU/US standards for protective clothing can be made. 13.4.2 Gowns The relevant South African standard, SANS 53795:2015, “Surgical drapes, gowns, and clean air suits, used as medical devices for patients, clinical for manufacturers, processors, and products, test methods, performance requirements, and performance levels,” is an adoption of EN 13795:2011+A1, since superseded by EN 13795-1 (performance requirements and test methods for surgical gowns and drapes) and EN 13795-2 (same, for clean air suits). For details on EN 13795-1, the standard that is relevant to the scope of this guide, see 4.4.2.1. Table 13.6 shows the requirements for gowns in the South African market compared to those of the EU and US markets. 68 January 2022. Communication with SABS. 242 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 13.6: Comparison between EU, US, and South African standards for gowns Notes: • For a more detailed comparison of EU and US standards (including test methods), see 4.4.2.3 of this guide. • For simplicity, only requirements related to barrier performance of gown materials and seams are specified. Color code: Green: Products made to the South African standard are likely to meet or exceed the EU or US standard Yellow: Products made to the South African standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the South African standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US ANSI/AAMI PB70:2012 (all EU South Africa (Market) gowns) EN 13795-1:2019 SANS 53795:2015 COMPARISON/COMMENTS standard ASTM F2407-20 Surgical gowns Surgical gowns (surgical gowns) and ASTM F3352-19 (isolation gowns) SANS 53795 is an adoption of Characteristic/ Requirement/testing Requirement/testing Requirement/testing EN 13795 (since replaced by EN property method method method 13795-1) ≤ 300 CFU (less critical ≤ 300 CFU (less critical The Association for the areas) areas) Advancement of Medical Note: For critical product Note: For critical product Instrumentation (AAMI) PB 70 Resistance to dry areas, wet bacterial areas, wet bacterial n/a microbial penetration standard specifically excludes penetration limits apply penetration limits apply instead instead dry microbial penetration from its scope EN ISO 22612:2005 EN ISO 22612 IB ≥ 2.8 (critical areas, IB ≥ 2.8 (critical areas, standard performance) standard performance) US requires (only for Level 4) Resistance to wet a stricter characteristic (viral IB = 6.0 (critical areas, IB = 6.0 (critical areas, n/a bacterial penetration penetration; see next row in high performance) high performance) table) EN ISO 22610:2006 EN ISO 22610 Pass (AQL 4%, RQL=20%) Viral penetration n/a n/a (AAMI Level 4) ASTM F1671 ≤ 300 CFU/100 cm2 ≤ 300 CFU/100 cm2 Cleanliness microbial/ n/a bioburden EN ISO 11737-1:2018 EN ISO 11737-1 Log10 (lint count) ≤ 4.0 Optional in the US Log10 (lint count) ≤ 4.0 Particle release IPM ≤3.5 In EN 13795-1, the Index for EN ISO 9073-10:2004 Particulate Matter (IPM) and the EN ISO 9073-10 lint count have been combined 243 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US ANSI/AAMI PB70:2012 (all EU South Africa (Market) gowns) EN 13795-1:2019 SANS 53795:2015 COMPARISON/COMMENTS standard ASTM F2407-20 Surgical gowns Surgical gowns (surgical gowns) and ASTM F3352-19 (isolation gowns) SANS 53795 is an adoption of Characteristic/ Requirement/testing Requirement/testing Requirement/testing EN 13795 (since replaced by EN property method method method 13795-1) For critical areas/zones, US limits ≥ 20 cm H2O (critical ≥ 20 cm H2O (critical are the same as EU/South African ≥ 20 cm H2O (AAMI areas, std. performance) areas, std. performance) Level 2) ones (for standard performance) ≥ 100 cm H2O (critical ≥ 100 cm H2O (critical or lower (for high performance); Water resistance ≥ 50 cm H2O (AAMI areas, high performance) areas, high performance) limits in the US apply only to (hydrostatic pressure) Level 3) ≥ 10 cm H2O (less critical ≥ 10 cm H2O (less critical critical zone components (akin (AQL 4%, RQL=20%) areas) areas) to critical areas in the EU/South AATC 127 Africa); EU/South African and US EN ISO 811:2018 EN 20811 methods are similar ≤ 4.5 g (AAMI Level 1) Limits in the US apply only to critical zone components (akin ≤ 1.0 g (AAMI Level 2 Water resistance and 3) to critical areas in the EU/South n/a n/a (impact penetration) Africa) (AQL 4%, RQL=20%) AATC 42 or NWSP 80.3 ≥ 40 kPa ≥ 40 kPa Bursting strength (dry) ≥ 40 kPa (critical areas) ≥ 40 kPa (critical areas) (wet) EN ISO 13938:1:1999 EN ISO 13938:1 Higher limit in the US compared to the EU/South Africa. ≥ 20 N ≥ 20 N Additionally, limits are set for Tensile strength (dry) ≥ 20 N (critical areas) ≥ 20 N (critical areas) ≥ 30 N tear strength (≥ 10 N per ASTM D5587 or D5733) and seam (wet) EN 29073-3:1992 EN 29073-3 ASTM D5034 strength (≥ 30 N per ASTM D1683/ D1683M). Physical property limits are Same for all barrier levels per AAMI Pass Pass Biocompatibility n/a ANSI/AAMI BE78 or EN ISO 10993-1:2009 ISO 10993-10 Packaging for terminally Validated sterilized medical Assurance level of manufacturing and Sterility devices is recommended sterilization process: processing procedures according to EN ISO at least 10-6 shall be used 11607 series Class 1 Manufacturer to provide Flammability No explicit requirements fire risk information 16 CFR 1610 Optional: - Water vapor Comfort (depends on a Comfort (depends on a transmission rate Other criteria to variety of properties) variety of properties) (ASTM D6701) consider - Evaporative resistance (ASTM F1868, Part B) - etc. 244 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 14 PRODUCT-SPECIFIC COMPARISONS (UK) As of December 31, 2021, British (BS EN) standards, which are “designated” under the PPE Regulation and the Medical Device Directive (as applicable in the UK), are identical to the EN “harmonized” ones. This situation may diverge in the future due to the exit of the UK from the EU (see 3.12). At present, however, comparison tables against EU/US requirements are relatively straightforward. 14.1 Masks 14.1.1 Respirators Table 14.1 shows the requirements for respirators in the UK market compared to those of the EU and US markets. Table 14.1: Comparison between EU, US, and UK standards for respirators Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 of this guide. Color code: Green: Products made to the UK standard are likely to meet or exceed the EU or US standard Yellow: Products made to the UK standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the UK standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US EU UK (Market) 42 CFR Part 84, EN 149:2001 +A1:2009, BS EN 149:2001 +A1:2009, COMPARISON/COMMENTS standard Series/Levels N95 and Classes FFP2 and FFP3 Classes FFP2 and FFP3 N99 Characteristic/ Requirement/testing Requirement/testing Requirement/testing British standard is currently property method method method a national adoption of EN 149 Practical Pass Pass Pass performance FFP2 FFP2 ≤ 11% (individual) ≤ 11% (individual) n/a ≤ 8% (mean) ≤ 8% (mean) Total inward leakage FFP3 FFP3 ≤ 5% (individual) ≤ 5% (individual) n/a ≤ 2 % (mean) ≤ 2 % (mean) 245 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US EU UK (Market) 42 CFR Part 84, EN 149:2001 +A1:2009, BS EN 149:2001 +A1:2009, COMPARISON/COMMENTS standard Series/Levels N95 and Classes FFP2 and FFP3 Classes FFP2 and FFP3 N99 Characteristic/ Requirement/testing Requirement/testing Requirement/testing British standard is currently property method method method a national adoption of EN 149 FFP2 FFP2 N95 ≥ 94% @ 95 L/min ≥ 94% @ 95 L/min ≥ 95% @ 85 L/min (NaCl (NaCl and paraffin oil— (NaCl and paraffin oil— BS only) EN 13274-7) EN 13274-7) Filtering efficiency N99 FFP3 FFP3 ≥ 99%@ 85 L/min (NaCl ≥ 99% @ 95 L/min ≥ 99% @ 95 L/min only) (NaCl and paraffin oil— (NaCl and paraffin oil—BS EN 13274-7) EN 13274-7) Compatibility with Pass Pass n/a skin Flammability Pass Pass n/a Carbon dioxide Average ≤ 1% by volume Average ≤ 1% by volume in n/a content in “dead space” “dead space” Field of vision Pass Pass Pass FFP2 FFP2 ≤ 70 Pa @ 30 L/min N95 ≤ 70 Pa @ 30 L/min ≤ 240 Pa @ 95 L/min ≤ 343 Pa @ 85 L/min Breathing resistance ≤ 240 Pa @ 95 L/min (inhalation) FFP 3 FFP 3 N99 ≤ 100 Pa @ 30 L/min ≤ 100 Pa @ 30 L/min ≤ 343 Pa @ 85 L/min ≤ 300 Pa @ 95 L/min ≤ 300 Pa @ 95 L/min Breathing FFP2 and FFP3 FFP2 and FFP3 N95 and N99 resistance ≤ 300 Pa @160 L/min ≤ 300 Pa @160 L/min ≤ 245 Pa @ 85 L/min (exhalation) Respirators are regulated as Category III PPE in the UK. 14.1.2 Medical face masks The UK standard for medical face masks, BS EN 14683:2009, is identical to EN 14683 (for details, see 4.1.2.1). Table 14.2 shows the requirements for medical face masks in the UK market compared to those of the EU and US markets. 246 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 14.2: Comparison between EU, US, and UK standards for medical face masks Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.2 of this guide. Color code: Green: Products made to the UK standard are likely to meet or exceed the EU or US standard Yellow: Products made to the UK standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the UK standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. EU UK US (Market) EN 14683:2019 BS EN 14683:2021 ASTM F2100–21 COMPARISON/COMMENTS standard Types I, II and IIR Types I, II and IIR Levels 1, 2 and 3 British standard is currently Characteristic/ Requirement/testing Requirement/testing Requirement/testing a national adoption of EN property method method method 14683 ≥ 95% (Type I) ≥ 95% (Type I) ≥ 95% (Level 1) Bacterial filtration ≥ 98% (Types II, IIR) ≥ 98% (Types II, IIR) ≥ 98% (Levels 2,3) Using efficiency (BFE) ASTM F2101 < 40 Pa/cm2 (Types <49 Pa/cm2 (Level 1) I, II) < 40 Pa/cm2 (Types I, II) Differential pressure < 60 Pa/cm (Type < 60 Pa/cm2 (Type IIR) 2 <58.8 Pa/cm2 (Levels 2, 3) IIR) (Tested at 8L/min (Tested at 8L/min flowrate) Using EN 14683 flowrate) Sub-micron ≥ 95 (Level 1) particulate filtration ≥ 98 (Levels 2,3) efficiency n/a n/a Both at 0.1 micron, using ASTM F2299 ≥ 10.7 kPa (Level 1) Not required (Types Not required (Types I, II) ≥16 kPa (Level 2) I, II) Splash-resistance ≥21.4 kPa (Level 3) pressure ≥ 16.0 kPa (Type IIR) ≥ 16.0 kPa (Type IIR) Using ISO 22609:2004 Using ASTM F1862 Using ISO 22609:2004 ≤ 30 CFU/g Microbial ≤ 30 CFU/g n/a cleanliness Using BS EN ISO 11737- Using EN ISO 11737-1:2018 1:2018 Pass Pass Pass Biocompatibility Using ISO EN 10993- Using BS EN ISO 10993- Using ISO 10993-1 1:2009 1:2009 Class 1 Flame spread n/a n/a Using 16 CFR Part 1610 Medical face masks are regulated as medical devices in the UK; see part 3.12.3. 14.1.3 Community face coverings In the UK, the specification BSI Flex 5555, Version 2.1 (April 2021), “Community face coverings—specification,” was adapted from the relevant CEN Workshop Agreement (CWA) 17553:2020. Table 14.3 shows the requirements for community face coverings in the UK market compared to those of the EU and US markets. Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.3.3 of this guide 247 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 14.3: Comparison between EU, US, and UK standards for community face coverings Color code: Green: Products made to the UK standard are likely to meet or exceed the EU or US standard Yellow: Products made to the UK standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the UK standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. UK (Market) EU US COMPARISON/ BSI Flex 5555, Version 2.1, standard CWA 17553:2020 ASTM F3502-21 COMMENTS April 2021 Characteristic/ Requirement/ Requirement/testing Requirement/testing method property testing method method EN 14683:2019, Annex Differential pressure ≤60 Pa/cm2 C (BS EN 14683:2019, Annex C) Subpart K of 42 CFR Part 84, or modified by §8.2 For EU, either breathing Breathing (≤ 70 Pa/cm ) 2 Inhalation resistance of 2.4 (Level 1 ≤ 15 mm H2O resistance or air Resistance EN 13274-3 (inhalation mbar; exhalation resistance of 3 permeability is measured resistance of 2.4 mbar; mbar (BS EN 13274-3:2001, Clause Level 2 ≤ 5 mm H2O) exhalation resistance 6, method 1 using a constant 3 mbar) flow of 95 l/min) EN ISO 9237 Air permeability n/a n/a (≥ 96 l/s/m2 @ 100 Pa) EN 13274-7:2019 or ≥ 70% Subpart K of 42 CFR Part 84, EN ISO 16890-2 or modified by §8.1 In accordance with the NaCl test For EU and UK, either PFE Particle EN ISO 21083-1:2018, filtration or measure BFE (see method in BS EN 13274-7:2019, or BFE is measured efficiency (PFE) below) Clause 6 with a flow of 95 l/min, (Level 1 ≥20%; For PFE, the CWA Particle size 3 (± 0.5) μm provides for alternative (Level 90% ≥ 90%; Level 2 ≥ 50%) Level 70% ≥ 70%) methods Particle size 3 (± 0.5) or μm Bacterial EN 14683:2019 filtration Manufacturer may choose to ≥ 95% UK exceeds the efficiency (BFE) Level 90% ≥ 90% provide the BFE results (as per BS EN 14683:2019, Annex B requirements in EU ASTM F 2101) along with PFE Level 70% ≥ 70% 248 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 14.2 Eye and face protection The relevant British Standard, BS EN 166, is currently a national adoption of EN 166 (for details, see 4.2.1). Table 14.4 shows the requirements for eye and face protection in the UK market compared to those of the EU and US markets. Table 14.4: Comparison between EU, US, and UK standards for eye and face protection Notes: • In general, requirements for lenses (only) have not been included. • For a more detailed comparison of EU and US standards (including test methods), see 4.2.1 of this guide. Color code: Green: Products made to the UK standard are likely to meet or exceed the EU or US standard Yellow: Products made to the UK standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the UK standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. UK (Market) EU US COMPARISON/ BS EN 166:2001 standard EN 166:2001 ANSI/ISEA Z87.1:2020 COMMENTS British standard is Characteristic/ Requirement/ Requirement/testing Requirement/testing method currently a national property testing method method adoption of EN 166 Construction and Pass Pass Pass materials (ANSI Z80.1) Headband Pass Pass n/a Basic (EU)/ fundamental (US)       requirements Pass Pass Field of vision (EN 168) (BS EN 168) Not a requirement, Not a requirement, Ellipse with axes ≥40 mm and ≥ Min. coverage area except for special except for special uses 33 mm uses Transmittance of > 74.4% > 74.4% oculars without filtering ≥ 85% (or ≥ 78% if relaxed optics) (EN 167) (BS EN 167) action ≤3% Haze n/a n/a (ASTM D1003-13) Pass Pass Increased robustness Pass (EN 168) (BS EN 168) Pass Pass Thermal stability n/a (EN 168) (BS EN 168) Pass Pass Resistance to corrosion Pass (EN 168) (BS EN 168) Pass Pass Resistance to ignition Pass (EN 168) (BS EN 168) Particular     requirements (EU) No color present for No color present for No color present for goggles goggles goggles Droplets and splashes Face shields pass the area Face shields pass the Face shields pass the of liquid coverage test area coverage test area coverage test (EN 168) (BS EN 168) 249 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets UK (Market) EU US COMPARISON/ BS EN 166:2001 standard EN 166:2001 ANSI/ISEA Z87.1:2020 COMMENTS British standard is Characteristic/ Requirement/ Requirement/testing Requirement/testing method currently a national property testing method method adoption of EN 166 Lateral protection Pass Pass Pass (optional) (EN 168) (BS EN 168) Optional requirements (EU) Resistance to fogging Time without Time without fogging Time without fogging ≥ 8 s US requirement added in (only for oculars, fogging ≥ 8 s (Acc to ≥ 8 s not complete eye the 2020 edition EN 168) (BS EN 168) protectors) 14.3 Gloves The relevant British Standards are currently national adoptions of EN 455 series (four parts); for details see 4.3.1.1. These standards apply to both medical examination gloves and surgical gloves. 14.3.1 Medical examination gloves Table 14.5 shows the requirements for medical examination gloves in the UK market compared to those of the EU and US markets. Table 14.5: Comparison between EU, US, and UK standards for medical examination gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.1 of this guide. Color code: Green: Products made to the UK standard are likely to meet or exceed the EU or US standard Yellow: Products made to the UK standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the UK standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US ASTM – material specific UK (Market) EU D6319 (nitrile) BS EN 455 series COMPARISON/COMMENTS standard EN 455 series D3578 (rubber) D5250 (PVC) D6977 (polychloroprene) Characteristic/ Requirement/ Requirement/testing Requirement/testing British Standards are currently Property testing method method method national adoptions of the EN 455 series Freedom from AQL =1.5 AQL =1.5 AQL =2.5 holes (EN 455-1:2020) (BS EN 455-1:2020) (ASTM D5151) 250 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US ASTM – material specific UK (Market) EU D6319 (nitrile) BS EN 455 series COMPARISON/COMMENTS standard EN 455 series D3578 (rubber) D5250 (PVC) D6977 (polychloroprene) Characteristic/ Requirement/ Requirement/testing Requirement/testing British Standards are currently Property testing method method method national adoptions of the EN 455 series Non-thermoplastic Non-thermoplastic AQL = 4.0 materials materials Nitrile ≥ 14Mpa/ ≥6.0N ≥6.0N elongation ≥400% Force at break (N) / Latex (natural) UK and EU standards specify ≥ 14Mpa / minimum absolute force (N) for Tensile strength Thermoplastic Thermoplastic materials Elongation ≥ 500% (Mpa), elongation materials (PVC, PE) samples taken from the glove (PVC, PE) at break (%) Polychloroprene (varies with thickness); ASTM ≥ 3.6N ≥ 3.6N ≥ 14Mpa/elongation ≥ 400% specifies in terms of tensile strength (Also, after (Mpa— force per unit area) ageing/challenge) PVC ≥ 11Mpa/elongation (EN 455-2 :2015, (BS EN 455-2 :2015, ≥ 300% method A of ISO method A of ISO (ASTM D412, ASTM D573 23529:2010) 23529:2010) [ageing]) Pass (EN ISO 10993-5 Pass (BS EN ISO 10993-5 Biocompatibility Pass (FDA regulations) and -10) and -10) ≤ 2.0mg/glove (powder- free gloves) ≤ 2.0 mg/glove (BS Powder residue ≤ 2.0 mg/glove (EN 455- EN 455-3, BS EN ISO ≤ 10 mg/dm2 (powdered content 3, EN ISO 21171:2006) 21171:2006) gloves) (ASTM D6124) “Manufacturer shall ≤ 200 µg/dm2 “Manufacturer shall monitor the content Aqueous soluble monitor the content Only for rubber gloves in natural rubber latex in natural rubber latex protein content gloves and shall try gloves and shall try to (ASTM D5712) to minimize it” (BS EN minimize it” (EN 455-3) 455-3) ≤ 10 µg/dm2 Extractable antigenic protein Optional Optional Only for rubber gloves content (ASTM D6499) EN 455-4 refers to BS EN 455-4 refers to Pass EN ISO 11607 (sterile BS EN ISO 11607 (sterile Sterility (US Pharmacopeia) barrier integrity during barrier integrity during shelf-life) shelf-life) Medical examination gloves are regulated as Class I medical devices in the UK (see 3.12.1). 14.3.2 Surgical gloves Table 14.6 shows the requirements for surgical gloves in the UK market compared to those of the EU and US markets. 251 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 14.6: Comparison between EU, US, and UK standards for surgical gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.2 of this guide. Color code: Green: Products made to the UK standard are likely to meet or exceed the EU or US standard Yellow: Products made to the UK standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the UK standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US UK (Market) EU ASTM D3577-19 BS EN 455 series COMPARISON/COMMENTS standard EN 455 series Type 1: Natural rubber Type 2: Synthetic rubber Characteristic/ Requirement/ Requirement/ Requirement/testing British standards are currently national property testing method testing method method adoptions of the EN 455 series Freedom from AQL = 0.65 AQL = 0.65 AQL = 1.5 holes (EN 455-1:2020) (BS EN 455-1:2020) (ASTM D5151) AQL = 4.0 Type 1: Latex (natural) Force at break BS and EN standards specify minimum ≥18Mpa/elongation ≥560% absolute force (N) for samples taken (N) / All materials All materials from the glove (varies with thickness); Tensile strength ≥ 9.0N ≥ 9.0N ASTM specifies in terms of tensile (Mpa), elongation Type 2: Synthetic rubber strength (Mpa—force per unit area) (%) (EN 455-2 :2015, (BS EN 455-2 :2015, ≥12Mpa/elongation ≥490% method A of ISO method A of ISO (Also, after 23529:2010) 23529:2010) ageing/challenge) (ASTM D412, ASTM D573 (ageing)) Pass Pass Pass Biocompatibility (EN ISO 10993-5 and (BS EN ISO 10993-5 and -10) (FDA regulations) -10) ≤ 2.0 mg/glove ≤ 2.0 mg/glove ≤ 2.0mg/glove Powder residue (EN 455-3, EN ISO (BS EN 455-3, BS EN content (ASTM D6124) 21171:2006) ISO 21171:2006) “Manufacturer shall “Manufacturer shall monitor the content ≤ 200 µg/dm 2 monitor the content Aqueous soluble in NRL gloves and in NRL gloves and (ASTM D5712) protein content shall try to minimize shall try to minimize it” (EN 455-3, Annex it” (BS EN 455-3, Annex A) A) Extractable ≤ 10 µg/dm2 Optional Optional antigenic protein content (EN 455-3, Annex B) (BS EN 455-3, Annex B) (ASTM D6499) BS EN 455-4 refers EN 455-4 refers to Pass to BS EN ISO 11607 EN ISO 11607 (sterile Sterility (sterile barrier (US Pharmacopeia) barrier integrity integrity during shelf- during shelf-life) life) Surgical gloves are regulated as Class I medical devices in the UK (see 3.12.1) 252 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 14.4 Clothing 14.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) The relevant British standards are currently national adoptions of EN ISO 13688, EN 14126, EN 14605, and EN 13034. Table 14.7 shows the requirements for protective clothing in the UK market compared to those of the EU and US markets. Table 14.7: Comparison between EU, US, and UK standards for protective clothing Notes: • For a more detailed comparison of EU and US standards (including test methods), see 4.4.1 of this guide. • For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components, such as visors, are not included). • For protection against infective agents only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection—Type 4), Type 6 (limited protection against liquid chemicals), and Type PB [6] (partial-body protection—Type 6). Color code: Green: Products made to the UK standard are likely to meet or exceed the EU or US standard Yellow: Products made to the UK standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the UK standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. COMPARISON/ Market EU UK US COMMENTS Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method I. General EN ISO BS EN ISO NFPA 1999:2018 requirements 13688:2013+A1:2021 13688:2013+A1:2021 No harmful No harmful substances substances present present Innocuousness No specific requirements No azo dyes present No azo dyes present Acceptable (Section 6.1) Note: Design requirements only ≥650 g/(m224 h) Note: In the US for single- Acceptable Acceptable use garments/ensembles “moisture vapor transmission Design and comfort (Annex C) (Annex C) rate” is specified (section 8.28 and ASTM E96) ≥450 W/m2 Note: In the US for multiple- use garments/ensembles “total heat loss test” is specified (section 8.32 and ASTM F1868) 253 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets COMPARISON/ Market EU UK US COMMENTS Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method EN 14126:2003 & EN BS EN 14126:2003 & BS 14605:2005+A1:2009 EN 14605:2005+A1:2009 II. Protection (for Types 4 and (for Types 4 and PB [4]) or EN NFPA 1999:2018 against infective PB [4]) or BS EN 13034:2005+A1:2009 13034:2005+A1:2009 (for agents (for Types 6 and PB Types 6 and PB [6]) [6]) 1. Materials requirements a) Mechanical Abrasion resistance is Class 1 to 6 (highest) Class 1 to 6 (highest) considered as a precondition Abrasion resistance (cl. 4.4 of EN 14325 & (cl. 4.4 of BS EN 14325 & BS to barrier performance of EN ISO 12947-2) EN ISO 12947-2) materials (ASTM D4157) Class 1 to 6 (highest) Class 1 to 6 (highest) Flex fatigue is considered Flex cracking (cl. 4.5, 4.6 EN 14325 & (cl. 4.5, 4.6 BS EN 14325 & as a precondition to barrier resistance EN ISO 7854, method BS EN ISO 7854, method performance of materials B) (ASTM F392) B) Single-use: “Tear-resistance test two” ≥17 N (section 8.38 and ASTM D5733 Class 1 to 6 (highest) Class 1 to 6 (highest) for non-woven) Trapezoidal tear (EN 14325 & EN ISO (BS EN 14325 & BS EN ISO resistance 9073-4:1997) Multiple-use: “Tear-resistance 9073-4:1997) test one” ≥36 N (section 8.7 and ASTM D5587 for woven) ≥50 N (section 8.4 and ASTM D5034) Class 1 to 6 (highest) Class 1 to 6 (highest) Bursting strength was Tensile strength (cl. 4.9 of EN 14325 & (cl. 4.9 of BS EN 14325 & BS Also bursting strength: EN ISO 13934-1) ≥66N (single-use) eliminated in EU and UK EN ISO 13934-1) ≥222.5N (multiple-use) (section 8.5 & ASTM D3787) ≥12N (single-use) Class 1 to 6 (highest) Class 1 to 6 (highest) Puncture resistance (cl. 4.10 of EN 14325 & (cl. 4.10 of BS EN 14325 & ≥25N (multiple-use) EN 863) BS EN 863) (section 8.6 and ASTM D2572) b) Chemical resistance Permeation by Class 1 to 6 (highest) Class 1 to 6 (highest) chemicals (EN ISO 6529, method (BS EN ISO 6529, method A (applicable to Types A for liquids) for liquids) 4 and PB [4]) Repellency to liquids In the US it is called “water- Class 1 to 3 (highest) ≤30% absorption resistance test”; Class 1 to 3 (highest) (Section 8.31) (applicable to Types (ISO 6530) (ISO 6530) it applies only to multiple- 6 and PB [6]) use garments/ensembles Penetration by liquids Class 1 to 3 (highest) Class 1 to 3 (highest) (ISO 6530) (applicable to Types (ISO 6530) 6 and PB [6]) c) Flammability Resistance to Pass or min. class 1 Flame spread time≥3.5 s Pass or min. class 1 (cl. ignition or flame (cl. 4.14 EN 14325 & EN 4.14 BS EN 14325 & BS EN (section 8.39 and ASTM (more stringent) 13274-4, method 3) 13274-4, method 3) D1230) 254 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets COMPARISON/ Market EU UK US COMMENTS Characteristic/ Requirement/ Requirement/testing Requirement/testing property testing method method method d) Penetration by infective agents Class 1 to 6 (highest) Contaminated Pass (cl. 4.1.4.1 of EN 14126, Class 1 to 6 (highest) Note: In the US the “bio- liquids under (cl. 4.1.4.1 of BS EN 14126, ISO 16603 and ISO penetration test one” applies hydrostatic pressure ISO 16603 and ISO 16604) (section 8.3 and ASTM F1671) 16604) Mechanical contact with contaminated Class 1 to 6 (highest) Class 1 to 6 (highest) liquids (wet (cl. 4.1.4.2 of EN 14126 (cl. 4.1.4.2 of BS EN 14126 n/a bacterial and EN ISO 22610) and BS EN ISO 22610) penetration) (Biologically) Class 1 to 3 (highest) Class 1 to 3 (highest) contaminated liquid n/a (cl. 4.1.4.3 of EN 14126) (cl. 4.1.4.3 of BS EN 14126) aerosols Contaminated As above As above solid particles (cl. 4.1.4.4 of EN 14126 (cl. 4.1.4.4 of BS EN 14126 n/a (dry microbial and ISO 22612) and ISO 22612) penetration) 2. Whole-suit requirements Pass Pass (EN ISO 17491-4 Pass (Section 8.2) (BS EN ISO 17491-4 Mist test (Type 6) (method A) as Note: In the US the “liquid (method A) as modified by modified by cl. 5.2 of tight integrity test one” cl. 5.2 of BS EN 13034) applies EN 13034) Pass Pass Liquid spray test (cl. 4.3.4.2 etc. of EN Pass (cl. 4.3.4.2 etc. of BS EN (Section 8.2) (Type 4) 14605 and EN ISO 14605 and BS EN ISO 17491-4 [method B]) 17491-4 (method B)) Pass Pass Demonstration of garment (EN 14605/EN 13034— (BS EN 14605/BS functionality is included as Practical “seven movements” EN 13034— “seven part of the liquid integrity performance movements” sequence testing applied to garments sequence while while wearing the suit) (ASTM F1154) wearing the suit) 14.4.2 Gowns The relevant British standard, BS EN 13795-1, is currently a national adoption of EN 13795-1 (for details on the EN, see 4.4.2.1). Table 14.8 shows the requirements for gowns in the UK market compared to those of the EU and US markets. 255 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 14.8: Comparison between EU, US, and UK standards for gowns Notes: • For a more detailed comparison of EU and US standards (including test methods), see 4.4.2.3 of this guide. • For simplicity, only requirements related to barrier performance of gown materials and seams are specified. Color code: Green: Products made to the UK standard are likely to meet or exceed the EU or US standard Yellow: Products made to the UK standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the UK standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US ANSI/AAMI PB70:2012 (all EU UK (Market) gowns) EN 13795-1:2019 BS EN 13795-1:2019 COMPARISON/COMMENTS standard ASTM F2407-20 Surgical gowns Surgical gowns (surgical gowns) and ASTM F3352-19 (isolation gowns) Characteristic/ Requirement/testing Requirement/testing Requirement/ British standard is currently a property method method testing method national adoption of EN 13795-1 ≤ 300 CFU (less critical ≤ 300 CFU (less critical The Association of the areas) areas) Advancement of Medical Note: For critical product Note: For critical Instrumentation (AAMI) PB 70 Resistance to dry areas, wet bacterial product areas, wet n/a microbial penetration standard specifically excludes dry penetration limits apply bacterial penetration instead limits apply instead microbial penetration from its scope EN ISO 22612:2005 BS EN ISO 22612:2005 IB ≥ 2.8 (critical areas, IB ≥ 2.8 (critical areas, standard performance) standard performance) US requires (only for Level 4) Resistance to wet IB = 6.0 (critical areas, IB = 6.0 (critical areas, n/a a stricter characteristic (viral bacterial penetration high performance) high performance) penetration; see next row in table) EN ISO 22610:2006 BS EN ISO 22610:2006 Pass (AQL 4%, RQL=20%) Viral penetration n/a n/a (AAMI Level 4) ASTM F1671 Cleanliness microbial/ ≤ 300 CFU/100 cm ≤ 300 CFU/100 cm2 2 n/a bioburden EN ISO 11737-1:2018 BS EN ISO 11737-1:2018 Log10 (lint count) ≤ 4.0 Log10 (lint count) ≤ 4.0 Particle release Optional in the US EN ISO 9073-10:2004 BS EN ISO 9073-10:2004 ≥ 20 cm H2O ≥ 20 cm H2O (critical (critical areas, std. For critical areas/zones, US limits ≥ 20 cm H2O (AAMI areas, std. performance) performance) are the same as EU/UK ones (for Level 2) standard performance) or lower ≥ 100 cm H2O (critical ≥ 100 cm H2O Water resistance ≥ 50 cm H2O (AAMI (for high performance); limits in areas, high performance) (critical areas, high (hydrostatic pressure) Level 3) performance) the US apply only to critical zone ≥ 10 cm H2O (less critical (AQL 4%, RQL=20%) components (akin to critical areas areas) ≥ 10 cm H2O (less critical areas) in the EU/UK); EU/UK and US AATC 127 EN ISO 811:2018 methods are similar BS EN ISO 811:2018 256 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US ANSI/AAMI PB70:2012 (all EU UK (Market) gowns) EN 13795-1:2019 BS EN 13795-1:2019 COMPARISON/COMMENTS standard ASTM F2407-20 Surgical gowns Surgical gowns (surgical gowns) and ASTM F3352-19 (isolation gowns) Characteristic/ Requirement/testing Requirement/testing Requirement/ British standard is currently a property method method testing method national adoption of EN 13795-1 ≤ 4.5 g (AAMI Level 1) Limits in the US apply only to ≤ 1.0 g (AAMI Levels 2 and 3) critical zone components (akin to Water resistance n/a n/a critical areas in the EU/UK) (impact penetration) (AQL 4%, RQL=20%) AATC 42 or NWSP 80.3 ≥ 40 kPa ≥ 40 kPa Bursting strength (dry) ≥ 40 kPa (critical areas) ≥ 40 kPa (critical areas) (wet) EN ISO 13938:1:1999 BS EN ISO 13938:1:1999 Higher limit in the US compared to the EU/UK. Additionally, limits ≥ 20 N ≥ 20 N are set for tear strength (≥ 10 N per Tensile strength (dry) ≥ 20 N (critical areas) ≥ 20 N (critical areas) ≥ 30 N ASTM D5587 or D5733) and seam (wet) EN 29073-3:1992 BS EN 29073-3:1992 ASTM D5034 strength (≥ 30 N per ASTM D1683/ D1683M). Physical property limits are same for all barrier levels per AAMI Pass Pass Pass Biocompatibility ANSI/AAMI BE78 or EN ISO 10993-1:2009 BS EN ISO 10993-1:2009 ISO 10993-10 Packaging for Packaging for terminally terminally sterilized sterilized medical Assurance level of medical devices Sterility devices is recommended sterilization process: is recommended according to EN ISO at least 10-6 according to BS EN ISO 11607 series 11607 series Manufacturer to Class 1 Manufacturer to provide Flammability provide fire risk fire risk information information 16 CFR 1610 Optional: - Water vapor Comfort (depends on a Comfort (depends on a transmission rate Other criteria to variety of properties) variety of properties) (ASTM D6701) consider - Evaporative resistance (ASTM F1868, Part B) - etc. Surgical gowns are regulated as medical devices in the UK; see 3.12.3. 257 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets PART 15 PRODUCT-SPECIFIC COMPARISONS (VIETNAM) 15.1 Masks 15.1.1 Respirators There is currently no Vietnamese equivalent to EN 149 or to 42 Code for Federal Regulations (CFR) Part 84 for respirators. TCVN 12325:2018, “Requirements and test methods for dust filters,” is derived from EN 143:2000 but is not directly relevant. The test methods of TCVN 7312:2003, “Personal respiratory protective devices— dust masks with filter,” are specified in TCVN 8389-1 (see section on face masks below) but TCVN 7312 is not explicitly mentioned in any COVID-19-related Vietnamese announcements. Therefore, no comparison table to EU/US requirements can be provided. 15.1.2 Face masks In Vietnam the categorization of face masks is not the same as in the EU or the United States. Vietnam has two relevant standards, as follows: • TCVN 8389-1:2010, “Medical face masks—Part 1: Normal medical face masks,” combine some of the characteristics of respirators and surgical masks according to the EU/US classifications. Additional requirements in Vietnam, not commonly found in other standards, are tests for the absence of heavy metals and for the field of vision (according to TCVN 3159) • TCVN 8389-2:2010, “Medical face masks—Part 2: Medical face masks preventing bacteria,” includes all the requirements of “normal” masks but also requires masks to have a bactericide on their external surface, thus giving them a bacterial filtration efficiency (BFE) of almost 100 percent (but measured in a much simpler way than in the EU/United States). They are also sterile. Table 15.1 shows the requirements for medical face masks in the Vietnamese market compared to those of the EU and US markets. 258 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Table 15.1: Comparison between EU, US, and Vietnam standards for medical face masks Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.1 and 4.1.2 of this guide. Color code: Green: Products made to the Vietnamese standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Vietnamese standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Vietnamese standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. EU Vietnam US (Market) EN 14683:2019 TCVN 8389-1 and -2, ASTM F2100–21 COMPARISON/COMMENTS standard Types I, II and IIR Normal and antibacterial Levels 1, 2 and 3 Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method Not required for masks ≥ 95% (Type I) per TCVN 8389-1 ≥ 95% (Level 1) >99.99% for masks Testing method for Vietnam is Bacterial filtration different (simpler) than for EU efficiency (BFE) per TCVN 8389-2 (with ≥ 98% (Levels 2,3) and US ≥ 98% (Types II, IIR) antibacterial surface); tested at 10L/min flowrate Using ASTM F2101 <49 Pa/cm2 (Level 1) Units of measurement for < 40 Pa/cm2 (Types I, II) 89 Pa (specified as 9mm acceptance criteria and test Differential pressure < 60 Pa/cm2 (Type IIR) H2O) <58.8 Pa/cm2– (Levels methods differ significantly from 2,3) those in the EU and US (Tested at 8L/min Using TCVN 7312 with a flowrate of @ 30 l/min using EN 14683 flowrate) ≥ 95% (Level 1) Sub-micron ≥ 90% particulate filtration ≥ 98% (Levels 2,3) n/a efficiency Using TCVN 7312 with a flowrate of 30 l/min Both at 0.1 micron, using ASTM F2299 Not required (Types I, II) n/a ≥ 10.7 kPa (Level 1) ≥16 kPa (Level 2) Splash-resistance ≥ 16.0 kPa (Type IIR) pressure n/a Using ISO 22609:2004 ≥21.4 kPa (Level 3) Using ASTM F1862 Not required for ≤ 30 CFU/g “simple” masks; see Microbial cleanliness Using EN ISO 11737- n/a sterility requirement for 1:2018 antibacterial masks Pass Pass Biocompatibility Using ISO EN 10993- n/a Using ISO 10993-1 1:2009 Class 1 Flame spread n/a n/a Using 16 CFR Part 1610 Limits specified for As, Pb, Heavy metals n/a n/a Hg, Sb and Cd Validated sterilization Requirement only for Validated sterilization Sterility process (optional antibacterial masks; using process (optional requirement) Vietnamese Pharmacopeia requirement) ≥ 94% Field of vision n/a n/a Using TCVN 3159 “Antibacterial” masks are regulated in Vietnam as medical devices; see 3.13.3. The situation for “normal” masks is not clear-cut. 259 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 15.1.3 Community face coverings No directly relevant standard for community face coverings in Vietnam has been identified. However, a technical regulation (decision No. 87z0/QD-BYT dated March 12, 2020, on temporary technical guidelines for fabric anti-droplet and bacteria prevention face masks) provides relevant specifications and makes reference to standards TCVN 8389-1:2010 and TCVN 8389-2:2010 for medical masks. Table 15.2 shows the requirements for community face coverings in the Vietnamese market compared to those of the EU and US markets. Table 15.2: Comparison between EU, US, and Vietnam standards for community face coverings Note: For a more detailed comparison of EU and US standards (including test methods), see 4.1.3 of this guide. Color code: Green: Products made to the Vietnamese standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Vietnamese standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Vietnamese standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. Vietnam (Market) EU US Decision No. 870/ COMPARISON/COMMENTS standard CWA 17553:2020 ASTM F3502-21 QD-BYT Characteristic/ Requirement/ Requirement/ Requirement/ property Testing method Testing method Testing method EN 14683:2019, Annex C Subpart K of 42 CFR Part 84, (≤ 70 Pa/cm2) modified by §8.2 Breathing (Level 1 ≤ 15 mm H2O resistance EN 13274-3 (inhalation ≤9 mm H2O resistance of 2.4 mbar; Level 2 ≤ 5 mm H2O) exhalation resistance 3 mbar) EN ISO 9237 Air permeability n/a n/a (≥ 96 l/s/m2 @ 100 Pa) EN 13274-7 EN ISO 16890-2 Subpart K of 42 CFR Part 84, Particle filtration ≥ 90%; @ 40L/min modified by §8.1 efficiency (PFE) EN ISO 21083-1:2018, using oil mist (Level 1 ≥20%; Level 2 ≥ 50%) (Level 90% ≥ 90%; Level 70% ≥ 70%) Particle size 3 (± 0.5) μm EN 14683:2019 Bacterial filtration Manufacturer may choose to efficiency (BFE) (Level 90% ≥ 90%; n/a provide the BFE results (as per ASTM F 2101) along with PFE Level 70% ≥ 70%) Limits specified for Heavy metals n/a As, Pb, Hg, Sb, and n/a Cd 260 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 15.2 Eye and face protection No standards for eye and face protection in Vietnam have been identified. Therefore, no comparison table to the EU/US ones can be provided. 15.3 Gloves 15.3.1 Medical examination gloves The relevant standards are TCVN 6343-1:2007 (for gloves made of rubber/latex), identical to ISO 11193-1:2002 with A1:2007 (last revised in 2020) and TCVN 6343-2:2007 (made of PVC), identical to ISO 11193-2:2006 (current). For details on the ISO standards, see 4.3.1.1. For completeness, the standard TCVN 12326-5:2018, “Protective gloves against dangerous chemicals and micro-organisms—Part 5: Terminology and performance requirements for micro-organisms risks,” identical to ISO 374-5:2016 (current), is also mentioned. As it has been analyzed in section 4.3.1.1 on EU requirements for examination gloves, standards on “protective gloves” as opposed to “medical gloves” will not be further detailed Table 15.3 shows the requirements for medical examination gloves in the Vietnamese market compared to those of the EU and US markets. Table 15.3: Comparison between EU, US, and Vietnam standards for medical examination gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.1.3 of this guide. Color code: Green: Products made to the Vietnamese standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Vietnamese standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Vietnamese standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. US ASTM—material Vietnam specific TCVN 6343-1:2007 (Market) EU D6319 (nitrile) COMPARISON/ (rubber) standard EN 455 series D3578 (rubber) COMMENTS TCVN 6343-2:2007 D5250 (PVC) (PVC) D6977 (polychloroprene) Requirement/ Requirement/testing Requirement/testing Characteristic/property testing method method method AQL =1.5 AQL =2.5 Freedom from holes AQL =2.5 (EN 455-1:2020) (ASTM D5151) 261 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets US ASTM—material Vietnam specific TCVN 6343-1:2007 (Market) EU D6319 (nitrile) COMPARISON/ (rubber) standard EN 455 series D3578 (rubber) COMMENTS TCVN 6343-2:2007 D5250 (PVC) (PVC) D6977 (polychloroprene) Requirement/ Requirement/testing Requirement/testing Characteristic/property testing method method method AQL = 4.0 AQL = 4.0 Non-thermoplastic materials In general, the tensile Nitrile ≥ 14MPa/ properties and their ≥6.0N elongation ≥400% For rubber limits specified in the Vietnamese standards are ≥ 6.0 N an amalgam of the EU/ Latex (natural) US ones Elongation ≥ 500% (Type ≥ 14MPa / 1), 400% (Type 2) Force at break (N) / Elongation ≥ 500% Tensile strength (MPa), Vietnamese and EU Polychloroprene elongation at break (%) Thermoplastic For PVC standards specify ≥ 14MPa/elongation ≥ materials (PVC, PE) minimum absolute force (Also, after ageing/challenge) ≥ 7.0 N 400% (N) for samples taken ≥ 3.6N Elongation ≥ 350% from the glove (varies PVC ≥ 11MPa/elongation with thickness); ASTM ≥ 300% specifies in terms of (EN 455-2 :2015, tensile strength (MPa— (ASTM D412, ASTM D573 method A of ISO force per unit area) [ageing]) 23529:2010) Pass (EN ISO 10993-5 Biocompatibility No explicit requirements Pass (FDA regulations) and -10) ≤ 2.0mg/glove (powder- free gloves) ≤ 2.0mg/glove Powder residue content (EN 455-3, EN ISO n/a ≤ 10 mg/dm2 (powdered 21171:2006) gloves) (ASTM D6124) “Manufacturer shall ≤ 200 µg/dm2 Aqueous soluble protein monitor the content in NRL gloves and n/a Only for rubber gloves content shall try to minimize it” (EN 455-3) (ASTM D5712) ≤ 10 µg/dm2 Extractable antigenic Optional n/a Only for rubber gloves protein content (ASTM D6499) If gloves are sterilized, EN 455-4 refers to the nature of the Pass EN ISO 11607 (sterile Sterility sterilization process barrier integrity US Pharmacopeia shall be disclosed on during shelf-life) request 262 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 15.3.2 Surgical gloves The relevant standard, TCVN 6344:2007, is equivalent to ISO 10282:2002, though there is a later (2014) version of ISO 10282 (for details on the ISO standard, see 4.3.2.1). Table 15.4 shows the requirements for surgical gloves in the Vietnamese market compared to those of the EU and US markets. Table 15.4: Comparison between EU, US, and Vietnam standards for surgical gloves Note: For a more detailed comparison of EU and US standards (including test methods), see 4.3.2.3 of this guide. Color code: Green: Products made to the Vietnamese standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Vietnamese standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Vietnamese standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. Vietnam US (Market) EU TCVN 6344:2007 ASTM D3577-19 standard COMPARISON/COMMENTS EN 455 series Type 1: Natural rubber Type 1: Natural rubber Type 2: Synthetic rubber Type 2: Synthetic rubber Characteristic/ Requirement/testing Requirement/testing Requirement/testing property method method method Freedom from AQL = 0.65 AQL = 1.5 AQL = 1.5 holes (EN 455-1:2020) (ASTM D5151) EU standard does not specify AQL = 4.0 AQL = 4.0 AQL Force at break (N) Type 1: Latex (natural) All materials Type 1: Latex (natural) ≥18MPa/elongation Tensile strength ≥18MPa/elongation ≥560% ≥560% EU standards specify minimum (MPa), elongation ≥ 9.0N (%) Type 2: Synthetic rubber absolute force (N) for samples (EN 455-2 :2015, method Type 2: Synthetic rubber ≥12Mpa/elongation ≥490% taken from the glove (varies (Also, after A of ISO 23529:2010) ≥12Mpa/elongation with thickness); ASTM and ageing/challenge) ≥490% (ASTM D412, ASTM D573 TCVN standards specify in [ageing]) terms of tensile strength (MPa­—force per unit area) TCVN specifies generally similar Pass Pass Pass Biocompatibility testing methodology with EU/ (EN ISO 10993-5 and -10) (FDA regulations) US ≤ 2.0 mg/glove ≤ 2.0mg/glove Powder residue (EN 455-3, EN ISO n/a content (ASTM D6124) 21171:2006) “Manufacturer shall ≤ 200 µg/dm2 Aqueous soluble monitor the content in NRL gloves and shall try n/a (ASTM D5712) protein content to minimize it” (EN 455-3, Annex A) Extractable ≤ 10 µg/dm2 Optional antigenic n/a protein content (EN 455-3, Annex B) (ASTM D6499) Gloves shall be EN 455-4 refers to EN sterilized; the nature of ISO 11607 (sterile barrier the sterilization process Pass Sterility integrity during shelf- shall be disclosed on US Pharmacopeia request life) 263 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets 15.4 Clothing 15.4.1 Full-body and partial-body garments (other than surgical/isolation gowns) The only standard that could be identified is TCVN 6689:2021, identical to ISO 13688:2013 +AMD1:2021 (current). TCVN 6689 only specifies general requirements about (any kind of) protective clothing and it supplements standards with requirements for specific protection. No TCVN could be identified that is similar to EN 14126 (against infective agents) but the latter is accepted by authorities in Vietnam. Table 15.5 shows the requirements for protective clothing in the Vietnamese market compared to those of the EU and US markets. Table 15.5: Comparison between EU, US, and Vietnam standards for protective clothing Notes: • For a more detailed comparison of EU and US standards (including test methods), see 4.4.1 of this guide. • For simplicity, only requirements for materials and whole suits are included (that is, requirements for seams, joins, assemblages, and integral components, such as visors, are not included). • For protection against infective agents only the following protection types, as defined in the standards, are considered here: Type 4 (spray-tight), Type PB [4] (partial-body protection— Type 4), Type 6 (limited protection against liquid chemicals) and Type PB [6] (partial-body protection—Type 6). Color code: Green: Products made to the Vietnamese standard are likely to meet or exceed the EU or US standard Yellow: Products made to the Vietnamese standard might not meet the European or US standard but are similar. Additional testing may be required if conformity to the EU or US standard is to be claimed Red: Significantly different criteria—products made to the Vietnamese standard are not likely to meet the EU or US standard and/or additional testing will be required Blue: Differences in criteria and/or test methods mean it is not possible to make a direct comparison Note: Testing standard is only mentioned if it is not defined in the product specification. Market EU Vietnam US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ Property Testing method Testing method Testing method No TCVN standard could be identified I. General EN ISO that is similar to EN 14126 (protection TCVN 6689:2021 NFPA 1999:2018 requirements 13688:2013+A1:2021 against infective agents) but EN 14126 seems to be accepted in Vietnam, as well No harmful substances No harmful No specific present Innocuousness substances present TCVN is identical to ISO 13688 + AMD1 No azo dyes present requirements No azo dyes present 264 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Vietnam US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ Property Testing method Testing method Testing method Acceptable (section 6.1) Note: Design requirements only ≥650 g/(m224 h) Note: In the US for single-use garments/ ensembles “moisture Acceptable Acceptable vapor transmission Design and (Annex C) Assessment in Annex rate” is specified comfort C (section 8.28 and ASTM E96) ≥450 W/m2 Note: In the US for multiple-use garments/ ensembles “total heat loss test” is specified (section 8.32 and ASTM F1868) EN 14126:2003 & EN 14605:2005+A1:2009 II. Protection (for Types 4 and PB [4]) or EN No requirements NFPA 1999:2018 against infective 13034:2005+A1:2009 agents (for Types 6 and PB [6]) 1. Materials requirements No requirements a) Mechanical for mechanical properties Abrasion resistance Class 1 to 6 (highest) is considered as Abrasion a precondition to (cl. 4.4 of EN 14325 & EN n/a resistance barrier performance of ISO 12947-2) materials (ASTM D4157) Flex fatigue is Class 1 to 6 (highest) considered as a Flex cracking precondition to (cl. 4.5, 4.6 EN 14325 & n/a resistance barrier performance of EN ISO 7854, method B) materials (ASTM F392) Single-use: “Tear- resistance test two” ≥17 N (section 8.38 and ASTM Class 1 to 6 (highest) D5733 for non-woven) Trapezoidal tear (EN 14325 & EN ISO n/a resistance Multiple-use: ‘tear 9073-4:1997) resistance test one’ ≥36 N (Section 8.7 & ASTM D5587 for woven) ≥50 N (section 8.4 and ASTM D5034) Class 1 to 6 (highest) Tensile strength (cl. 4.9 of EN 14325 & EN n/a Also bursting strength: Bursting strength was eliminated in EU ISO 13934-1) ≥66N (single-use) ≥222.5N (multiple-use) (section 8.5 and ASTM D3787) 265 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Vietnam US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ Property Testing method Testing method Testing method ≥12N (single-use) Class 1 to 6 (highest) Puncture ≥25N (multiple-use) (cl. 4.10 of EN 14325 & n/a resistance EN 863) (section 8.6 and ASTM D2572) No requirements for b) Chemical chemical resistance resistance properties Permeation by Class 1 to 6 (highest) chemicals (EN ISO 6529, method A (applicable to n/a for liquids) Types 4 and PB [4]) Repellency to liquids Class 1 to 3 (highest) ≤30% In the US it is called “water-absorption (applicable to n/a (section 8.31) resistance test”; it applies only to (ISO 6530) multiple-use garments/ensembles Types 6 and PB [6]) Penetration by liquids Class 1 to 3 (highest) (applicable to n/a (ISO 6530) Types 6 and PB [6]) No requirements for c) Flammability flammability Flame spread time Resistance to Pass or min. class 1 ≥3.5 s ignition or flame (cl. 4.14 EN 14325 & EN n/a (more stringent) 13274-4, method 3) (section 8.39 and ASTM D1230) d) Penetration by Requirement/ infective agents testing method Pass Contaminated Class 1 to 6 (highest) Note: In the US the “bio- liquids under (cl. 4.1.4.1 of EN 14126, penetration test one” n/a hydrostatic ISO 16603 and ISO applies (section 8.3 and ASTM pressure 16604) F1671) Mechanical contact with Class 1 to 6 (highest) contaminated (cl. 4.1.4.2 of EN 14126 n/a n/a liquids (wet and EN ISO 22610) bacterial penetration) (Biologically) Class 1 to 3 (highest) contaminated n/a n/a (cl. 4.1.4.3 of EN 14126) liquid aerosols Contaminated As above ISO 22612:2006 has been adopted as solid particles (cl. 4.1.4.4 of EN 14126 n/a n/a TCVN 11539:2016; there is, however, no (dry microbial and ISO 22612) TCVN product standard referring to it penetration) 2. Whole-suit No requirements for requirements whole suits Pass Pass (section 8.2) (EN ISO 17491-4 (method Mist test (Type 6) n/a Note: In the US the A) as modified by cl. 5.2 “liquid tight integrity of EN 13034) test one” applies 266 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets Market EU Vietnam US COMPARISON/COMMENTS Characteristic/ Requirement/ Requirement/ Requirement/ Property Testing method Testing method Testing method Pass Liquid spray test Pass (cl. 4.3.4.2 etc. of EN n/a (section 8.2) (Type 4) 14605 and EN ISO 17491- 4 [method B]) Demonstration of Pass garment functionality Practical (EN 14605/EN 13034— is included as part of “seven movements n/a the liquid integrity performance sequence” while testing applied to wearing the suit) garments (ASTM F1154) 15.4.2 Gowns No standards for medical gowns in Vietnam have been identified. Therefore, no comparison table can be provided. For international gown standards accepted in Vietnam, see 3.13.2. 267 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets ANNEX A OTHER CONSIDERATIONS FOR MANUFACTURERS AND PURCHASERS OF COVID-19-RELATED PPE A1 Sustainability of PPE The increased global use of PPE during the COVID-19 pandemic has brought with it considerable risk to the environment. Many national administrations have mandated the use of PPE (primarily face coverings) as part of front-line measures to prevent the spread of the virus. Non-woven (polymer-based) single-use face coverings are the PPE of choice for many users given their convenience, price, and ease of access. This global uptake in the use and disposal of single-use PPE (masks, gloves, gowns, aprons, and so on) has compromised solid waste management strategies at municipal and national levels in many countries, as waste management administrations and facilities grapple with the sheer volume of discarded PPE and medical waste more generally. The issue is further compounded by increased consumption of other single-use commodities used in the battle against COVID-19 and the fact that recommended practice PPE disposal requirements call for specialist processing that is not available in sufficient capacity at many waste management facilities. In its recent report “Innovation in Manufacturing Personal Protective Equipment—Toward Sustainability and Circularity,” 69 IFC estimates that since the start of the pandemic, the amount of plastic waste generated globally has been 1.6 million tons per day. It is further estimated that 3.4 billion single-use face masks and shields are being discarded every day. 70 These numbers alone are a clear indicator that PPE manufacturers, users/consumers, and governments need to collaborate and strive to be more ecologically conscious when using and disposing of PPE. PPE sustainability and its impact on global pollution levels are urgent priorities that need to be addressed along the PPE lifecycle of resin-to-recycling. This approach will require a rethinking of fundamental strategies around PPE materials, production processes and technology, transportation and distribution, utilization and disposal. Each of these themes is not without its own set of complexities and challenges. And although the analysis of these issues is not the primary focus of this guide, attention does need to be drawn to the critical role that global standards can play toward realizing PPE sustainability objectives. All relevant stakeholders should discuss ways in which sustainability aspects can be incorporated into existing and new PPE standards. 69 https://www.ifc.org/wps/wcm/connect/industry_ext_content/ifc_external_corporate_site/manufacturing/resources/ innovation+in+manufacturing+personal+protective+equipment. 70 https://www.sciencedirect.com/science/article/pii/S2405844021004485. 268 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets During the event hosted by the British Standards Institution (BSI) in 2021 to celebrate the 75th anniversary of the International Organization for Standardization (ISO),71 representatives of all 163 national ISO Members signed the “London Declaration.” 72 The development of this declaration was led by BSI, with the stated intention of considering climate science in every new standard that is created and retrospectively for all existing standards as they are revised. This is precisely where the focus of sustainability in PPE should be directed—making sure that the necessary “sustainable product policy framework” is in place across different governments,“reinventing” or significantly improving the key value chains, and finally, but no less importantly, educating and empowering users. Providing better information to consumers leads to better-informed purchasing and this can certainly be achieved through standards. To do so, sustainability and material efficiency aspects must be included in PPE- related legislation and standardization. Governments should focus on establishing and harmonizing certain policy and standardization must-haves that would enable PPE products to move toward more sustainable options, allowing for their reusability. This technical guide shows that standards and certification for PPE products have so far focused on requirements for safety, health functions, and conformity with the relevant legislation, without containing much data on circularity, reuse, or reprocessing. There is a need to focus on embedding product requirements related to durability, use/reuse, and recyclability into the policies and standards, as well as developing the corresponding testing methods. Sustainability in PPE must be achieved by following common circular economy principles that have proven effective in other sectors (that is, designing products so that the resources needed in their manufacture are kept to a minimum and the life of those resources is extended for as long as possible via reuse, recycling and remanufacture). These principles and approaches should guide future policy development for PPE management after the current pandemic and in the case of any future pandemic. Future standards must, to the extent possible, include aspects on: • Sustainability and material efficiency • Defining performance requirements for the PPE products in a way that manufacturers can offer innovative products that achieve both the necessary protection for users and durability/reusability • Instructions on how to care for reusable products (clear cleaning and maintenance instructions, maximum use time, and similar) • Clear waste and disposal procedures. A2 Diversity and inclusion in PPE In most health care systems, 75—80 percent of staff are women. According to the recent Women in Global Health report, 73 “women [make up] 90 percent of nurses and have been the vast majority of health care workers in patient-facing roles in the pandemic […] Therefore, if medical PPE is not fit for women, it is not fit for the majority of the health workforce.” Most PPE that is available is based on generic anthropometric data. Generally, for those who fall outside the data that are considered to represent 5—95 percent of various user segments, the hope of finding anything to fit them is low, regardless of gender. Additionally, anthropometric data is limited to only a few metrics and does not provide a complete anatomically accurate picture. During the pandemic, health care workers from non-Caucasian populations faced additional challenges with mask fit due to diverse face shapes, whether they may be smaller or larger depending on gender and race. The COVID-19 pandemic further highlighted 71 https://www.bsigroup.com/en-GB/about-bsi/uk-national-standards-body/what-is-the-national-standards-body/iso-week-2021/. 72 https://www.bsigroup.com/en-GB/about-bsi/uk-national-standards-body/london-declaration/. 73 https://www.womeningh.org/fitforwomen. 269 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets major challenges in governance and inequalities particularly among those from black, Asian, and minority ethnic groups. Simply making something a bit bigger or a bit smaller does not address diversity needs. Notwithstanding some efforts from ISO to address such issues for the case of respiratory protection devices with the ISO 16976 series of standards, 74the next challenge to address is that standards written for PPE often fail to take into account a diverse group of end users. With ever more diversity in the workforce, there has been an effort to expand the sizes offered in various types of PPE, and companies are producing PPE such as goggles and coveralls for a larger range of body shapes and sizes. While available information on the degree of design efforts in creating these products is limited, suppliers suggest a growing demand for “diversely sized PPE”. However, producing diversely sized PPE is only the first step. There are other barriers such as problems with supply chains, lack of promotion of diversely sized PPE, a lack of awareness among employers, procurement officials and others of the need for alternative PPE and economics of costs vs. return. The provision of a suitable selection of PPE to meet all sizes and genders is market driven. Historically there was no money to be made by producing customized PPE for a diverse minority of the workforce. 75All these factors hinder getting diversely sized PPE from the manufacturer to the workers who need it. Standards need to play a crucial role in helping the industry deliver on this challenge and make the necessary efforts to develop better methods and processes for ensuring that PPE is more inclusive and diverse. ISO in particular has recognized the need for gender responsive and inclusive standards and aims to create adequate tools for technical committees that ensure standards address these concerns. Launched in 2019, the ISO Gender Action Plan outlines five priority areas that focus on collecting data, creating a network to share best practice and raising awareness of standards in support of gender equality and women’s empowerment. Notwithstanding some efforts by ISO, historically many standardization technical committees have often been made up mostly of men, who have not always considered the specific needs of women or minorities when developing standards. Therefore, promoting diversity in the committees themselves is a step in the right direction. This will ensure that the needs, experiences and concerns of all end users are an integral part of the design and performance of the product, process, or service being standardized. A3 Approaches to conformity assessment and accreditation According to the standard ISO/IEC 17000,76 conformity assessment is “a demonstration that specified requirements are fulfilled.” This can involve, among other things, testing, inspection, and certification of products as well as management system certification. The associated laboratories, inspection agencies and certification bodies are collectively referred to as “conformity assessment bodies” (CABs), and the requirements to be fulfilled are typically defined in regulations, standards, or purchasing specifications. Depending on the regulatory framework covering PPE in a specific market, conformity assessment may sometimes be carried out by the manufacturer itself (resulting in a ‘supplier’s declaration of conformity’) but in other cases can necessitate the use of an independent third-party conformity assessment body designated by the regulatory authority. The conformity assessment body is typically chosen by the manufacturer from a list provided by the regulator (called ‘notified bodies’ in the EU – see 3.1.3). Choosing a suitable conformity assessment body can be sometimes a daunting task, especially in developing economies where there may not be many that are active and/or recognized in any given field. The meaning of “accreditation” in the conformity assessment context is different from that of “hospital accreditation.” The formal definition is “third-party attestation related to a conformity assessment body, conveying formal demonstration of its competence, consistent operation, and impartiality in performing specific conformity assessment activities.” 74 https://www.iso.org/committee/291088/x/catalogue/p/1/u/1/w/0/d/0. 75 BSI.“Diversity in PPE. ” White paper. 76 ISO/IEC 17000:2020.“Conformity assessment—vocabulary and general principles. ” 270 TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT Technical regulations and standards for PPE in select markets There is typically only one formally recognized national accreditation body in each country77 (see Part 3 of this guide). These operate within a global network to facilitate trade across borders. Multilateral recognition arrangements between accreditation bodies are overseen at the global level by the International Laboratory Accreditation Cooperation (ILAC) via its Mutual Recognition Arrangements (MRAs) and the International Accreditation Forum (IAF) via its Multilateral Recognition Arrangements (MLAs)78 and, at the regional level, by organizations such as the Interamerican Accreditation Cooperation, European Accreditation Cooperation, and others. These arrangements are underpinned by peer evaluations against the requirements of the international standard for the operation of accreditation bodies (ISO/IEC 17011) which ensure a consistent approach to accreditation. In this way confidence and trust can be placed in the conformity assessment of products that are manufactured or purchased by organizations located in different parts of the world. Claims made by conformity assessment bodies that they are accredited (and therefore can be relied on to provide valid attestations of conformity) should be verified by consulting the ILAC and IAF websites79 to confirm that the conformity assessment body’s accreditation body is a signatory of the relevant multilateral recognition arrangements and then by confirming via the accreditation body’s website that the conformity assessment body has an appropriate accreditation scope for the services it is providing. Accredited third-party conformity assessment is not the only way to demonstrate conformity, though. Standards such as ASTM F305080 and ISO/IEC 1706781 define different types of conformity assessment approaches that can be applied to PPE, ranging from self-declaration by the supplier (supplier’s declaration of conformity) to formal product certification by an accredited third-party certification body. The cost of conformity assessment services needed for entry into specific markets depends greatly on the scope of the activities to be performed. These might need to include accredited certification of the supplier’s quality management system (based on ISO 9001 for general PPE, or on ISO 13485 for PPE that are covered by medical device regulations), testing of a product sample in an accredited laboratory, or full product certification. It is not realistic to try to provide cost estimates in this guide, because the starting point and the efforts involved are likely to be different for every potential supplier of PPE (taking into consideration any previous experience in manufacturing similar products for other markets and any pre-existing certifications). It is also important also to keep in mind that one important component of the overall cost relates to the internal development costs incurred by the manufacturer itself, to establish reliable systems and processes that ensure the product will consistently meet the relevant requirements over time. These costs can often significantly outweigh the costs of the associated conformity assessment procedures. 77 One notable exception is the United States, where several accreditation bodies operate within a competitive environment. 78 The IAF MLA and the ILAC MRA are based on the same concept, though the terminology used is slightly different. 79 https://ilac.org/signatory-search/ and https://iaf.nu/en/recognised-abs/. ” 80 ASTM F3050-21.“Standard guide for conformity assessment of personal protective clothing and equipment. ” 81 ISO/IEC 17067:2013.“Conformity assessment—fundamentals of product certification and guidelines for product certification schemes. 271 About IFC IFC—a member of the World Bank Group—is the largest global development institution focused on the private sector in emerging markets. We work in more than 100 countries, using our capital, expertise, and influence to create markets and opportunities in developing countries. In fiscal year 2021, we invested $31.5 billion in total commitments, including $23.3 billion in long-term finance and $8.2 billion in short-term finance,to private companies and financial institutions in emerging and developing economies, leveraging the power of the private sector to end extreme poverty and boost shared prosperity. For more information, visit www.ifc.org.