1.1 本标准提供了进行呼吸器适配能力测试的详细说明，以确定空气净化、半面罩式呼吸器的适配性，其中包括过滤面罩式呼吸器和配备任何类型颗粒过滤器的弹性呼吸器。目的是增加可用呼吸器适合普通工人群体的可能性。本标准向呼吸器购买者和使用者提供了更高的保证，即当根据29 CFR 1910.134在工作场所进行适合性测试时，符合本标准要求的呼吸器可以有效地适合面部不同长度和宽度的人，如长和窄或短和宽，作为完整呼吸保护计划的一部分。 1.2 以国际单位制表示的数值应视为标准值。 本标准不包括其他计量单位。 1.3 研究者有责任确定是否需要良好的实验室实践（GLP标准-40 CFR，FIFRA第160部分），并在适当时遵循这些规范。 1.4 本标准不涉及监管机构制定的具体产品性能标准；看见 2.2 详细信息。 1.5 本标准并不免除每位佩戴者进行个人呼吸器适配测试的必要性。 1.6 本标准并不保证每个呼吸器佩戴者都能够在特定制造商的单尺寸或多尺寸呼吸器型号上达到所需的匹配系数。口罩佩戴者必须始终有机会试用其他型号或其他制造商的口罩。 1.7 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户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。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 在美国，当《联邦法规》第42卷第84部分（42 CFR 84）于1995年颁布时，按照《联邦法规》第30卷第11部分的规定，对某些颗粒物进行乙酸异戊酯气密性试验- 取下呼吸器。这些微粒去除呼吸器设计用于防止:( 1. )空气污染水平不低于0.05的各种金属烟雾 毫克/米 3. ，和( 2. )空气污染水平低于0.05的灰尘、烟雾和薄雾 毫克/米 3. 或放射性核素。醋酸异戊酯测试被取消，因为微粒口罩在测试之前必须进行修改，并且当时没有其他适用于国家职业安全与健康研究所（NIOSH）进行批准测试的适用测试 ( 1. ) . 4. 有人担心，改进后的呼吸器可能与市场上销售的型号具有不同的装配特性。据NIOSH称，取消这一要求还可以进一步研究认证匹配测试方法的有效性 ( 1. ) . 5.2 NIOSH在2008年和2009年期间对市场上的101种呼吸器型号进行了基准测试，使用了与本文所述类似的测试 ( 2. ) . 对结果进行分析，以制定关键测试参数和通过/失败标准选项，用于半面罩空气净化颗粒物呼吸器的呼吸器匹配能力测试 ( 3. ) . 据NIOSH称，大约30 % 测试的模型中有个没有良好的拟合特性 ( 2. ) . 这也得到了已发表研究的支持 ( 4. , 5. ) . 本标准制定了一项性能要求，称为呼吸器适配能力，以评估呼吸器的面部密封特性。 5.3 本标准可用于评估佩戴者群体中的所有微粒去除呼吸器。符合适配能力要求的呼吸器模型将能够适配其设计的面部尺寸和形状。 为了实现这一目标，该方法有必要在通过符合本标准规定的合格/不合格标准的良好口罩的同时，拒绝佩戴不合适的口罩。据认为，该标准将增加满足该要求的呼吸器在适当适合测试、佩戴和使用时适用于各种预期佩戴者的可能性。

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. ====== Significance And Use ====== 5.1 In the U.S., when 42 Code of Federal Regulations Part 84 (42 CFR 84) was promulgated in 1995, the isoamyl acetate tightness test as described in 30 Code of Federal Regulations Part 11 for certain particulate-removing respirators was removed. These particulate-removing respirators were designed as protection against: ( 1 ) fumes of various metals having an air contamination level not less than 0.05 mg/m 3 , and ( 2 ) dusts, fumes, and mists having an air contamination level less than 0.05 mg/m 3 or radionuclides. The isoamyl acetate test was removed because particulate respirators had to be modified before they could be tested and there were no other available fit tests suitable to the National Institute for Occupational Safety and Health (NIOSH) for approval testing at the time ( 1 ) . 4 There was a concern that the modified respirators may have had different fitting characteristics from the versions marketed. According to NIOSH, removing this requirement also allowed for further research on the effectiveness of certification fit testing methods ( 1 ) . 5.2 NIOSH conducted benchmark testing of 101 respirator models on the market during 2008 and 2009, using a similar test to that described herein ( 2 ) . The results were analyzed to develop key test parameters and pass/fail criteria options for a respirator fit capability test for half-facepiece air-purifying particulate respirators ( 3 ) . According to NIOSH, approximately 30 % of the models tested did not have good fitting characteristics ( 2 ) . This was also supported by published research ( 4 , 5 ) . This standard establishes a performance requirement called respirator fit capability to assess respirator face-sealing characteristics. 5.3 This standard can be used to evaluate all particulate-removing respirators on a population of wearers. A respirator model meeting the fit capability requirement will be capable of fitting the facial sizes and shapes for which it was designed. To achieve this goal, it is necessary for the method to reject poor-fitting respirators, while still passing well-fitting respirators meeting the pass/fail criteria established in this standard. It is thought that this standard will increase the likelihood that respirators meeting this requirement will fit a wide variety of their prospective wearers when properly fit tested, donned, and used.