1.1 本规范旨在帮助确保屏障面罩符合规定要求( 1. )通过减少从佩戴者的鼻子和嘴巴排出到空气中的气溶胶，为个人佩戴者提供源头控制手段；以及( 2. )微粒过滤的程度可能会减少佩戴者吸入的气溶胶量。 注1: 屏障面罩所提供的源头控制/保护取决于本规范中未考虑的几个因素，例如由于佩戴者的挑战（包括出汗、说话、打喷嚏）导致的材料退化，以及佩戴屏障面罩的时间长度。需要进一步的研究来扩大口罩保护效果的证据基础，特别是确定能够最大限度地提高其阻隔和过滤效果以及贴合度、舒适度、耐用性和消费者吸引力的材料组合。（https: //www.cdc.gov/cocoronavirus/2019-ncov/more/masking-science-sars-cov2.html.） 注2: 目前还没有确定的方法来测量屏障面罩、医用口罩或呼吸器的向外泄漏。本规范中没有任何内容涉及或暗示对向外泄漏的定量评估，也不能声称屏障面罩在多大程度上减少了过期的人类产生的气溶胶。 1.2 本规范规定了屏障面罩的最低设计、性能（测试）、标签、用户说明、报告和分类以及合格评定要求。 1.2.1 设计标准包括设置佩戴者鼻子和嘴上的最小面部覆盖面积，禁止打开通风口或阀门，要求有一种将屏障面部覆盖物保持在佩戴者头部的方法，并提供产品尺寸的表示。制造商还需要进行设计分析，以评估屏障面罩的呼出空气泄漏。 允许制造商按照本标准的规定进行定量测试，以补充设计分析。 1.2.2 性能和测试标准定义了最小屏障面覆盖过滤效率和气流阻力性能财产。亚微米颗粒物过滤效率代表了捕获和减少可能含有病毒和细菌的可吸入气溶胶的能力。气流阻力代表佩戴者在佩戴防护面罩时的呼吸舒适性或透气性。重复清洁或清洗对持续性能的影响适用于测量拟重复使用的屏障表面覆盖物的性能财产。制造商还可以提供细菌过滤效率（BFE）的测试结果，作为亚微米颗粒物过滤效率强制性性能测量的补充信息。 注3: 通过测试确定的障碍面覆盖物的主要性能标准是亚微米颗粒过滤效率和气流阻力。定量泄漏评估测试是可选的，用于提供信息，不需要。该测试不太可能代表屏障表面覆盖物的向外泄漏，也不应声称代表表面覆盖物提供的源控制量。细菌过滤效率测试也是可选的，不需要。它与亚微米过滤效率显著不同，BFE测试的结果不能互换或直接比较。本标准的范围不包括屏障面罩的附件。 1.2.3 标签要求规定了屏障表面覆盖物、直接包装以及销售点包装上出现的标签的最低含量。 1. 2.4 需要使用说明书来指导产品的选择和尺寸、正确使用（定位和调整）以及护理，包括清洁或清洗（如果打算重复使用产品）；告知产品注意事项和限制；并描述产品更换和处置程序。 1.2.5 符合性评估通过以下指南中的供应商符合性声明（SDOC）进行证明 功能3050 ，附件A3，模型A。SDOC指出，标记为符合要求的每个障碍面覆盖物都符合本规范的所有要求，包括设计标准、性能标准、测试方法、标签和用户信息。此外，符合本规范要求亚微米颗粒物过滤效率和气流阻力测试由经认证的实验室进行。 注4: 本规范不规定屏障面罩的任何形式的临时、有限或部分符合性，因为它们符合本规范是满足所有性能要求的功能，包括特定的过滤效率和透气性要求，以及所有适用的设计、标签、报告和用户信息要求。 1.3 本规范涉及一次性或可重复使用的屏障面罩。 1.4 本规范未涉及某些应用中存在的屏障面罩的独特附加性能属性，例如在存在火焰、高温、电弧或相关危险的环境中使用的阻燃服装，但建议屏障面罩也符合其他适用标准。 1.5 本规范不涉及抗菌或抗病毒材料、饰面或机制的使用，也不涉及药物、生物制品或纳米颗粒在屏障面罩中的使用。本规范也没有涉及清洁剂或其他化学品对屏障面罩进行清洁、消毒或消毒的功效。 注5: 关于使用抗菌材料、饰面或机制的声明；或在任何产品中使用药物、生物制品或纳米颗粒，使制造商受到包括美国在内的政府机构的监管。 美国食品药品监督管理局对这些产品提出了额外的安全性和有效性要求。看见 5.1.2 用于防护面罩结构中使用的无毒和无刺激性材料的要求。 1.6 本规范未涉及本规范中所涵盖的医用口罩的要求 第2100页 . 1.7 本规范中的任何内容均不得与42 CFR第84部分中规定的空气净化呼吸器标准或29 CFR 1910.134中规定的呼吸器使用要求相矛盾或取代这些标准。 1.8 本规范中的任何内容都不意味着屏障面罩有资格作为批准的呼吸保护装置，或获得美国食品药品监督管理局的批准，可在医疗环境中使用。 1.9 本规范中的任何内容都不意味着应将屏障面罩放置在非常年幼的儿童（<2岁）、任何呼吸困难的人或任何昏迷、丧失行为能力或在没有帮助的情况下无法移除屏障面罩的人身上。 1.10 以国际单位制或其他单位表示的数值应单独视为标准。每个系统中规定的值必须独立使用，不得以任何方式组合值。 1.11 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 注6: 有几个方面与屏障面罩的材料组成和设计有关，本规范中没有涉及这些方面，但需要注意其安全性、健康影响和对环境的影响，包括但不限于:潜在毒性饰面的浸出、材料中可吸入的有毒物质、，以及受监管的生物负载抑制剂。 1.12 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。

1.1 This specification is intended to help ensure barrier face coverings meeting the stated requirements provide ( 1 ) a means of source control for individual wearers by reducing expelled aerosols from the wearer’s nose and mouth into the air; and ( 2 ) a degree of particulate filtration that potentially reduces the amount of aerosols inhaled by the wearer. Note 1: The source control/protection provided by barrier face coverings depends on several factors not considered in this specification, such as material degradation from wearer challenges including perspiration, talking, sneezing, and the length of time the barrier face covering is worn. Further research is needed to expand the evidence base for the protective effect of face coverings and, in particular, to identify the combinations of materials that maximize both their blocking and filtering effectiveness, as well as fit, comfort, durability, and consumer appeal. (https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html.) Note 2: There are currently no established methods for measuring outward leakage from a barrier face covering, medical mask, or respirator. Nothing in this specification addresses or implies a quantitative assessment of outward leakage and no claims can be made about the degree to which a barrier face covering reduces expired human-generated aerosols. 1.2 This specification establishes minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings. 1.2.1 Design criteria include setting minimum areas of face coverage over the wearer’s nose and mouth, prohibiting open vents or valves, requiring a means for retaining the barrier face covering on the wearer’s head, and providing a representation of product sizing. Manufacturers are further required to perform a design analysis for assessing leakage of exhaled air from the barrier face covering. Manufacturers are permitted to conduct quantitative testing as specified in this standard to supplement the design analysis. 1.2.2 Performance and testing criteria define minimum barrier face covering filtration efficiency and airflow resistance performance properties. Sub-micron particulate filtration efficiency represents the ability to capture and reduce respirable aerosols that potentially contain viruses and bacteria. Airflow resistance represents the wearer’s ease of breathing or breathability while wearing the barrier face covering. The impact of repeated cleaning or laundering on continued performance is applied for measuring performance properties for those barrier face coverings that are intended for reuse. Manufacturers are permitted to also provide test results for bacterial filtration efficiency (BFE) as supplemental information to the mandatory performance measurement of sub-micron particulate filtration efficiency. Note 3: The principal performance criteria for barrier face covering determined by testing are sub-micron particle filtration efficiency and airflow resistance. Quantitative leakage assessment testing is optional for information purposes and is not required. This testing is not likely to be representative of outward leakage from the barrier face covering and should not be claimed to represent the amount of source control offered by the face covering. Bacterial filtration efficiency testing is also optional and not required. It is significantly different than sub-micron filtration efficiency, and the results of BFE testing cannot be interchanged or directly compared. The scope of this standard does not include accessories to barrier face coverings. 1.2.3 Labeling requirements specify the minimum content for labels that appear on the barrier face covering, its immediate packaging, and if different, point-of-sale packaging. 1.2.4 User instructions are required to guide selection and sizing, proper use (positioning and adjustment), and care including cleaning or laundering if product reuse is intended; inform on product cautions and limitations; and describe product replacement and disposal procedures. 1.2.5 Conformity assessment is demonstrated with a Supplier Declaration of Conformity (SDOC) following Guide F3050 , Annex A3, Model A. The SDOC states that each barrier face covering labeled as compliant has met all of the requirements of this specification including design criteria, performance criteria, test methods, labeling, and user information. Additionally, conformance to this specification requires that sub-micron particulate filtration efficiency and airflow resistance tests have been performed by a laboratory accredited for conducting these tests. Note 4: This specification does not provide for any form of provisional, limited, or partial conformance of barrier face coverings since their compliance with this specification is a function of meeting all performance requirements, including specific filtration efficiency and breathability requirements, as well as all applicable design, labeling, reporting, and user information requirements. 1.3 This specification addresses barrier face coverings that are either disposable or reusable. 1.4 This specification does not address the unique additional performance attributes of barrier face coverings that exist for certain applications, such as flame-resistant apparel used in environments where there are flame, high heat, electrical arc, or related hazards, but does recommend that barrier face coverings also conform to other standards as applicable. 1.5 This specification does not address the use of antimicrobial or antiviral materials, finishes, or mechanisms, nor the use of drugs, biologics, or nanoparticles in barrier face coverings. This specification also does not address the efficacy of cleaning agents or other chemicals for cleaning, disinfecting, or sanitizing barrier face coverings. Note 5: Claims made about the use of antimicrobial materials, finishes, or mechanisms; or the use of drugs, biologics, or nanoparticles in any product subject the manufacturer to regulatory oversight by government agencies, including the U.S. Food and Drug Administration in the United States, which applies additional safety and efficacy requirements to these products. See 5.1.2 for the requirement of nontoxic and non-irritating materials used in the construction of barrier face coverings. 1.6 This specification does not address requirements for medical face masks, which are covered in Specification F2100 . 1.7 Nothing in this specification is intended to contradict or replace criteria that are established in 42 CFR Part 84 for air-purifying respirators or requirements for use of respirators in accordance with 29 CFR 1910.134. 1.8 Nothing in this specification is intended to imply that barrier face coverings qualify as approved respiratory protection devices or have FDA clearance for use in a healthcare setting. 1.9 Nothing in this specification is intended to imply that barrier face coverings should be placed on very young children (<2 years), anyone who has trouble breathing, or anyone who is unconscious, incapacitated, or otherwise unable to remove barrier face coverings without assistance. 1.10 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way. 1.11 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Note 6: There are several aspects that relate to the material composition and design of barrier face coverings that are not addressed in this specification but warrant attention relative to their safety, health effects, and impact on the environment, including but not limited to: leaching of potentially toxic finishes, inhalable toxic substances from materials, and bioburden inhibitors subject to regulatory oversight. 1.12 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.