1.1 本指南描述了与个人防护服和设备（以下简称“PPE”）相关的合格评定（CA）要求的选项。本指南可选择性地用于定义PPE规范标准或配套ASTM符合性评估标准实践文件中的符合性评估要求 2. 与PPE规范标准相关。据了解，前一种方法不符合ISO指令第2部分第6.7节。 1.2 本指南无意要求对任何PPE规范标准或PPE的组成部分提出额外的合格评定要求。 1.3 本指南定义了符合美国卫生和公众服务部NIOSH国家个人防护装备符合性评估框架-基础设施的符合性评估原则和要求选项，以管理佩戴者因不合格PPE而面临的风险。 1.4 本指南确定了潜在危险和风险评估结果，可为其制定符合性评估方案（通常称为“计划”）以管理评估的风险。 1.5 本指南无意规定PPE或其整体组件的任何特定合格评定要求模型。 1.6 给定合格评定方案中的要求和活动应由合格评定方案所有者确定，或由PPE规范标准编写者定义，并且至少应基于第节中包含的标准 6. 本指南的。 1.7 本指南无意取代任何联邦、州或地方法律或法规。 1.8 本指南提供了有组织的信息收集或一系列选项，并不推荐具体的行动方案。本文件不能取代教育或经验，应与专业判断一起使用。 并非本指南的所有方面都适用于所有PPE情况。本ASTM指南不代表或取代必须根据其判断给定专业服务是否充分的谨慎标准，也不应在不考虑项目的许多独特方面的情况下应用本文件。本文件标题中的“标准”一词仅表示该文件已通过ASTM共识程序获得批准。 1.9 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。 1.10 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 个人防护装备规范的编写者提出了减轻规定的人身安全和健康危害的要求。 5.2 PPE的使用者和佩戴者希望这些产品的性能符合规定的规范，以帮助减轻个人危害。 5.3 合格评定要求是确保个人防护装备符合规范的一种方法。 5.3.1 应定义符合性评估要求，以解决确保个人防护装备为已识别危险提供保护所需的信心。（参见 附件A1 讨论标准应如何通过提供充分保护的性能和其他要求来解决危害和风险。） 5.3.2 合格评定要求是管理不合格PPE风险的一种手段，可以作为不合格产品的成本效益和受伤或疾病风险的平衡。 5.4 合格评定可以包括抽样和测试、检查、供应商声明、认证、监督以及质量和环境系统评估和注册。 它还可以包括表明供应商从第三方获得能力的认证。 5.4.1 符合性评估活动的要求的严格性和方案参与者的独立性可能不同，从供应商符合性声明（SDOC），到第三方独立测试、认证和其他符合性评估要求。 5.5 本指南确定了符合美国卫生和公众服务部NIOSH个人防护装备符合性评估国家框架的符合性评估选项——基础设施，作为管理不合格个人防护装备佩戴者的既定危险和风险的手段。 5.6 本指南进一步确定了可制定符合性评估方案的危险和风险。

1.1 This guide describes options for conformity assessment (CA) requirements relating to personal protective clothing and equipment (hereafter referred to as “PPE”). This guidance can optionally be used to define conformity assessment requirements in a PPE specification standard or in a companion ASTM conformity assessment Standard Practice document 2 associated with the PPE specification standard. It is understood that the former approach is not consistent with ISO Directive, Part 2, Section 6.7. 1.2 This guide is not intended to require additional conformity assessment requirements to any PPE specification standard or to the integral components of the PPE. 1.3 This guide defines conformity assessment principles and requirement options consistent with U.S. HHS NIOSH National Framework for Personal Protective Equipment Conformity Assessment – Infrastructure as a means to manage the risks to wearers to defined hazards from nonconforming PPE. 1.4 This guide identifies potential hazard and risk assessment outcomes for which a conformity assessment scheme (commonly referred to as a “program”) can be developed to manage assessed risks. 1.5 It is not the intent of this guide to prescribe any particular model of conformity assessment requirements for PPE or its integral components. 1.6 The requirements and activities in a given conformity assessment scheme should be determined by a conformity assessment scheme owner or can be defined by the PPE specification standard writers, and should be based, at a minimum, on the criteria contained in Section 6 of this guide. 1.7 This guide is not intended to supersede any federal, state, or local laws or regulations. 1.8 This guide offers an organized collection of information or a series of options and does not recommend a specific course of action. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this guide may be applicable in all PPE circumstances. This ASTM guide is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a project’s many unique aspects. The word “standard” in the title of this document means only that the document has been approved through the ASTM consensus process. 1.9 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. 1.10 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 Writers of PPE specifications produce requirements to mitigate defined personal safety and health hazards. 5.2 The users and wearers of PPE expect that these products will perform in conformance with stated specifications to help mitigate personal hazard(s). 5.3 Conformity assessment requirements are a means to provide confidence that PPE conform to specifications. 5.3.1 Conformity assessment requirements should be defined to address the confidence needed to ensure the PPE will provide protection for the identified hazard. (See Annex A1 for a discussion on how standards should address hazards and risks through performance and other requirements that provide adequate protection.) 5.3.2 Conformity assessment requirements are a means to manage the risks of nonconforming PPE and can serve as a balance of cost effectiveness and risk of injury or illness of a nonconforming product. 5.4 Conformity assessment can include sampling and testing, inspection, supplier’s declaration, certification, surveillance, and quality and environmental system assessment and registration. It can also include accreditation that indicates competence by the provider from a third party. 5.4.1 The requirements’ rigor and scheme participant independence of the conformity assessment activities can vary from a supplier declaration of conformity (SDOC), to third-party independent testing, certification, and other conformity assessment requirements. 5.5 This guide identifies options for conformity assessment consistent with the U.S. HHS NIOSH National Framework for Personal Protective Equipment Conformity Assessment – Infrastructure as a means to manage the defined hazards and risk to wearers of a nonconforming PPE. 5.6 This guide further identifies hazards and risks for which a conformity assessment scheme can be developed.