ASTM F3050-17

Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment

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 to 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.
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 28-Feb-2017
• ICS: 13.340.10 - Protective clothing
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.50 - PPE Conformity Assessment, Interoperability and Compatibility

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3050 − 17
Standard Guide for
Conformity Assessment of Personal Protective Clothing and
1
Equipment
This standard is issued under the fixed designation F3050; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.8 This guide offers an organized collection of information
oraseriesofoptionsanddoesnotrecommendaspecificcourse
1.1 This guide describes options for conformity assessment
of action. This document cannot replace education or experi-
(CA) requirements relating to personal protective clothing and
ence and should be used in conjunction with professional
equipment (hereafter referred to as “PPE”). This guidance can
judgment. Not all aspects of this guide may be applicable in all
optionally be used to define conformity assessment require-
PPE circumstances. This ASTM guide is not intended to
mentsinaPPEspecificationstandardorinacompanionASTM
2 representorreplacethestandardofcarebywhichtheadequacy
conformityassessmentStandardPracticedocument associated
of a given professional service must be judged, nor should this
with the PPE specification standard. It is understood that the
document be applied without consideration of a project’s many
former approach is not consistent with ISO Directive, Part 2,
unique aspects. The word “standard” in the title of this
Section 6.7.
document means only that the document has been approved
1.2 This guide is not intended to require additional confor-
through the ASTM consensus process.
mity assessment requirements to any PPE specification stan-
1.9 This standard does not purport to address all of the
dard or to the integral components of the PPE.
safety concerns, if any, associated with its use. It is the
1.3 Thisguidedefinesconformityassessmentprinciplesand
responsibility of the user of this standard to establish appro-
requirement options consistent with U.S. HHS NIOSH Na-
priate safety and health practices and determine the applica-
tional Framework for Personal Protective Equipment – Con-
bility of regulatory limitations prior to use.
formity Assessment Infrastructure as a means to manage the
2. Referenced Documents
risks to wearers to defined hazards from nonconforming PPE.
3
2.1 ASTM Standards:
1.4 This guide identifies potential hazard and risk assess-
D123 Terminology Relating to Textiles
ment outcomes for which a conformity assessment scheme
(commonly referred to as a “program”) can be developed to F1494 Terminology Relating to Protective Clothing
F2669 Performance Specification for Protective Clothing
manage assessed risks.
Worn by Operators Applying Pesticides
1.5 It is not the intent of this guide to prescribe any
F2962 Practice for Conformity Assessment of Protective
particular model of conformity assessment requirements for
Clothing Worn by Operators Applying Pesticides
PPE or its integral components.
4
2.2 Federal Regulations:
1.6 The requirements and activities in a given conformity
CFR Title 21, Part 7, Subpart C Recall Procedures
assessment scheme should be determined by a conformity 5
2.3 ISO Standards:
assessment scheme owner or can be defined by the PPE
ISO 9001:2015 Quality Management Systems – Require-
specification standard writers, and should be based, at a
ments
minimum, on the criteria contained in Section 6 of this guide.
ISO/IEC 17000:2004 Conformity Assessment – Vocabulary
1.7 This guide is not intended to supersede any federal, and General Principles
state, or local laws or regulations.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
1
This guide is under the jurisdiction of ASTM Committee F23 on Personal Standards volume information, refer to the standard’s Document Summary page on
Protective Clothing and Equipment and is the direct responsibility of Subcommittee the ASTM website.
4
F23.50 on Certification and PPE Interoperability. Available from U.S. Government Printing Office, Superintendent of
Current edition approved March 1, 2017. Published March 2017. Originally Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
approved in 2017. DOI: 10.1520/F3050-17. www.access.gpo.gov.
2 5
Practice F2962 establishes the conformity assessment requirements for Speci- Available from International Organization for Standardization (ISO), ISO
fication F2669. This is an example for having conformity assessment requirements Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
in a PPE practice document related to a PPE specification standard. Geneva, Switzerland, http://www.iso.org.
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