1.1 This guide describes options for conformity assessment (CA) requirements relating to personal protective clothing and equipment (hereafter referred to as PPE). This guide can optionally be used to define conformity assessment requirements in a PPE specification standard or a companion ASTM conformity assessment standard practice document 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 EquipmentConformity 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 (as 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 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 guide to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 1.9 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 projects 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.
A conformity assessment scheme is a means for managing hazards and risks associated with a nonconforming product. This requires participation by the conformity assessment stakeholders. Conformity assessment stakeholders can include other organizations such as suppliers, purchasers, certification bodies, testing laboratories, regulatory bodies, trade associations, labor associations, and so forth. Standards-writing groups are encouraged to engage in a thorough and thoughtful discussion of the advantages and disadvantages of independence and robustness of conformity assessment activities required to meet hazard/risk assessed. Conformity assessment activities with greater independence and requirements robustness can sometimes have unintended negative consequences, including being time consuming and expensive, and may not deliver proportional benefits to the user community. Conversely, conformity assessment activities with less independence and robustness, while cost effective, are reliant on claims from the manufacturer and may not be robust enough to serve stakeholder needs.
Keywordscertification; conformity assessment; hazard; personal protective clothing and equipment; PPE; quality assurance; risk; supplier declaration; third-party testing
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top