13.340.30 呼吸保护装置 标准查询与下载

ASTM F3502-22a 障碍面覆盖物的标准规范

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-sarscov2.html.) NOTE 2—There are currently no established methods for measuring outward leakage from a barrier face covering, medical mask, or respirator. 1 This specification is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee F23.65 on Respiratory. Current edition approved July 1, 2022. Published July 2022. Originally approved in 2021. Last previous edition approved in 2022 as F3502 – 22. DOI: 10.1520/ F3502-22A. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 1 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 Labelling 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 following Guide F3050, Annex A3, Model A to issue a declaration of conformity indicating that each barrier face covering labelled as compliant has met all of the requirements of this standard specification including design criteria, performance criteria, test methods, labelling, and user information. Additionally, conformance to this standard requires that sub-micron particulate filtration efficiency and airflow resistance tests have been performed by a laboratory accredited for conducting these tests. 1.3 This specification addresses all barrier face coverings and only barrier face coverings that are intended for either a single use (disposable) or multiple uses (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. NOTE 4—The use of antimicrobial materials, finishes, or mechanisms is generally subject to regulatory oversight by government agencies, including the U.S. Environmental Protection Agency and 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 (

Standard Specification for Barrier Face Coverings

ASTM F3502-22 障碍面覆盖物的标准规范

Standard Specification for Barrier Face Coverings

GSO ASTM F3387:2022 呼吸防护标准实践

1.1 This practice sets forth minimally accepted practices for occupational respirator use; provides information and guidance on the proper selection, use, and maintenance of respirators; and contains requirements for establishing, implementing, and evaluating respirator programs. 1.2 This practice covers the use of respirators to protect persons against the inhalation of harmful air contaminants and oxygen-deficient atmospheres in the workplace. The following are not covered by this practice: 1.2.1 Underwater breathing devices, 1.2.2 Aircraft oxygen systems, 1.2.3 Supplied-air suits, 1.2.4 Use of respirators under military combat conditions, and 1.2.5 Medical inhalators and resuscitators. 1.3 Units—The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.4 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. 1.5 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.

Standard Practice for Respiratory Protection

ASTM F3407-21 负压半面罩微粒呼吸器的呼吸器安装能力的标准试验方法

1.1 This standard provides detailed instructions for performing a respirator fit capability test to determine the fit of air-purifying, half-facepiece respirators, which will include both filtering facepiece respirators and elastomeric respirators equipped with any type of particulate filter. The purpose is to increase the probability that available respirators fit a general worker population. The standard provides increased assurance to respirator purchasers and users that respirators that meet the requirement of this standard can be expected to effectively fit persons with various lengths and widths of faces, such as long and narrow or short and wide, when fit tested in the workplace as part of a complete respiratory protection program in accordance with 29 CFR 1910.134. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 It is the responsibility of the investigator to determine whether good laboratory practices (GLP standards—40 CFR, Part 160 of FIFRA) are required and to follow them when appropriate. 1.4 This standard does not address specific product performance standards established by regulatory authorities; see 2.2 for details. 1.5 This standard does not eliminate the need for every wearer to undergo a personal respirator fit test. 1.6 This standard does not guarantee that every respirator wearer will be able to achieve the required fit factor on a particular manufacturer’s single-size or multi-size respirator model. Respirator wearers must always be given the opportunity to try other models or other manufacturers’ respirators. 1.7 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. 1.8 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.

Standard Test Method for Respirator Fit Capability for Negative-Pressure Half-Facepiece Particulate Respirators

ASTM F3537-21 呼吸器配合试验方法的标准指南

1.1 This guide provides guidance on how to conduct fit testing of tight-fitting respirators and appropriate methods to be used. Fit testing is only one element of a complete respiratory protection program. Examples of complete respiratory protection programs are defined in Practice F3387, 29 CFR 1910.134, and so forth. 1.2 Purpose—This guide provides requirements for conducting respirator fit testing and includes: 1.2.1 Qualifications for fit test operators, 1.2.2 Specific fit test methods, 1.2.3 Interpretation of fit test results, 1.2.4 Recordkeeping, and 1.2.5 Methods to validate new fit test methods. 1.3 Should and Shall—The provisions of this guide are mandatory in nature when the word “shall” is used and advisory in nature when the word “should” is used. 1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 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. 1.6 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.

Standard Guide for Respirator Fit Testing Methods

BS ISO 17420-5:2021 呼吸保护装置 性能要求 特殊应用消防和救援服务 提供可呼吸气体RPD和过滤RPD

Respiratory protective devices. Performance requirements. Special application fire and rescue services. Supplied breathable gas RPD and filtering RPD

BS PD ISO/TS 17420-8:2021 呼吸保护装置 性能要求 特殊应用化学、生物、放射性和核（CBRN）过滤和放射性核（RN）过滤RPD

Respiratory protective devices. Performance requirements. Special application chemical, biological, radiological and nuclear (CBRN) filtering and radiological-nuclear (RN) filtering RPD

ISO/TS 17420-8:2021 呼吸防护装置.性能要求.第8部分:特殊应用化学、生物、放射性和核（CBRN）过滤和放射性核（RN）过滤RPD

Respiratory protective devices — Performance requirements — Part 8: Special application chemical, biological, radiological and nuclear (CBRN) filtering and radiological-nuclear (RN) filtering RPD

ISO/TS 17420-9:2021 呼吸防护装置.性能要求.第9部分：特殊应用化学、生物、放射性和核（CBRN）提供的可呼吸RPD

Respiratory protective devices - Performance requirements - Part 9: Special application chemical, biological, radiological and nuclear (CBRN) supplied breathable RPD

BS ISO 16900-6:2021 呼吸保护装置 试验方法和试验设备 部件和连接的机械阻力/强度

Respiratory protective devices. Methods of test and test equipment. Mechanical resistance/strength of components and connections

T/SZBX 039-2021 随弃式防护口罩

本文件规定了随弃式防护口罩的术语与定义、分级和标记、技术要求、检测方法、产品标识和检验规则。

Disposable protective mask

21/30426351 DC BS ISO 16976-3 呼吸防护装置 人为因素 第 3 部分：呼吸环境中氧气的生理反应和限制以及二氧化碳的限制

BS ISO 16976-3. Respiratory protective devices. Human factors - Part 3. Physiological responses and limitations of oxygen and limitations of carbon dioxide in the breathing environment

21/30426345 DC BS ISO 16976-1 呼吸防护装置 人为因素 第 1 部分：代谢率和呼吸流速

BS ISO 16976-1. Respiratory protective devices. Human factors - Part 1. Metabolic rates and respiratory flow rates

ISO 16900-6:2021 呼吸保护装置 - 测试和测试设备的方法 - 第6部分:组件和连接的机械阻力/强度

This document specifies the method of test for the mechanical resistance and strength of components of respiratory protective devices.

Respiratory protective devices — Methods of test and test equipment — Part 6: Mechanical resistance/strength of components and connections

T/TTGA 003-2021 “领跑者” 标准评价要求 民用防护口罩

1 范围 本文件规定了民用防护口罩“领跑者”标准评价的术语和定义、评价指标体系、评价方法及等级划分。 本文件适用于民用防护口罩的企业标准水平评价。企业在制定企业标准时可参照使用，相关机构在制定企业标准“领跑者”评估方案时可参照使用。 本文件不适用于缺氧环境、水下作业、逃生、消防等特殊行业用呼吸防护用品，也不适用于婴幼儿呼吸防护用品。 2 规范性引用文件 3 术语和定义 4 评价指标体系 5 评价方法及等级划分

Assessment requirements for forerunner standards— Civil protective mask

T/TTGA 004-2021 “领跑者”标准评价要求 民用卫生口罩

1 范围 本文件规定了民用卫生口罩“领跑者”标准评价的术语和定义、评价指标体系、评价方法及等级划分。 本文件适用于民用卫生口罩的企业标准水平评价。企业在制定企业标准时可参照使用，相关机构在制定企业标准“领跑者”评估方案时可参照使用。 本文件不适用于缺氧环境、水下作业、逃生、消防等特殊行业用呼吸卫生用品，也不适用于婴幼儿呼吸卫生用品。 2 规范性引用文件 3 术语和定义 4 评价指标体系 5 评价方法及等级划分

Assessment requirements for forerunner standards— Civil sanitary mask

UNI EN 14387-2021 呼吸保护装置 气体过滤器和组合过滤器 要求、测试、标记

Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking

UNI EN 143-2021 呼吸保护装置 微粒过滤器 要求、测试、标记

Respiratory protective devices - Particle filters - Requirements, testing, marking

PN-EN 143-2021-07 E 呼吸保护装置 微粒过滤器 要求、测试、标记

Respiratory protective devices -- Particle filters -- Requirements, testing, marking

PN-EN 14387-2021-07 E 呼吸保护装置 气体过滤器和组合过滤器 要求、测试、标记

Respiratory protective devices -- Gas filter(s) and combined filter(s) -- Requirements, testing, marking