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.Scope 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 document2 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.
