1.1 本规范涵盖了用于提供医疗服务（如手术和患者护理）的医用口罩的制造材料的测试和要求。 1.1.1 本规范涉及带领带的医用口罩（外科口罩）和耳环（手术口罩或隔离口罩）。 1.2 本规范规定了医用面罩材料性能的分类。医用面罩材料的性能基于对细菌过滤效率、压差、亚微米微粒过滤效率、抗合成血液渗透性和可燃性的测试。 1.3 本规范未涉及医用面罩设计和性能的所有方面。 本规范没有具体评估医用面罩设计的有效性，因为它与整体屏障和透气性财产有关。 1.3.1 本规范不包括医用面罩的任何具体设计标准；然而，外科口罩的区别在于，与使用耳环将口罩固定在佩戴者面部的手术口罩或隔离口罩相比，外科口罩具有允许调整医用口罩尺寸的系带。 1.4 本规范未涉及某些医疗保健服务和暴露于吸入危害时可能需要的呼吸器等受管制呼吸防护设备的要求。 注1: 42 CFR第84部分描述了NIOSH批准的N95呼吸器的性能要求。FDA和NIOSH之间的谅解备忘录中描述了NIOSH批准的用于医疗保健环境的N95呼吸器的其他要求。FDA/NIOSH MOU 225-18-0062017年11月和NIOSH致制造商的符合性评估函，NIOSH CA 2018-10102018年11月。 1.5 以国际单位制表示的值应视为标准值。本标准不包括其他测量单位。 1.6 以下预防性警告仅适用于测试方法部分，第节 9 ，本规范: 本标准并不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建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.7 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《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。

1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care. 1.1.1 This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks). 1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. 1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to their overall barrier and breathability properties. 1.3.1 This specification does not include any specific design criteria for medical face masks; however, surgical masks are differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which use ear loops to affix the mask to the wearer’s face. 1.4 This specification does not address requirements for regulated respiratory protection devices such as respirators, which may be necessary for some healthcare services and exposure to inhalation hazards. Note 1: Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 The following precautionary caveat pertains only to the test methods portion, Section 9 , of this specification: 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. 1.7 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.