ASTM F3050-22a
(Guide)Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment
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 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 t...
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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.
Designation: F3050 − 22a
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 1.7 This guide is not intended to supersede any federal,
state, or local laws or regulations.
1.1 This guide describes options for conformity assessment
(CA) requirements relating to personal protective clothing and 1.8 This guide offers an organized collection of information
equipment (hereafter referred to as “PPE”). This guidance can oraseriesofoptionsanddoesnotrecommendaspecificcourse
optionally be used to define conformity assessment require- of action. This document cannot replace education or experi-
mentsinaPPEspecificationstandardorinacompanionASTM ence and should be used in conjunction with professional
2
conformityassessmentStandardPracticedocument associated judgment. Not all aspects of this guide may be applicable in all
with the PPE specification standard. It is understood that the PPE circumstances. This ASTM guide is not intended to
former approach is not consistent with ISO Directive, Part 2, representorreplacethestandardofcarebywhichtheadequacy
Section 6.7. of a given professional service must be judged, nor should this
document be applied without consideration of a project’s many
1.2 This guide is not intended to require additional confor-
unique aspects. The word “standard” in the title of this
mity assessment requirements to any PPE specification stan-
document means only that the document has been approved
dard or to the integral components of the PPE.
through the ASTM consensus process.
1.3 Thisguidedefinesconformityassessmentprinciplesand
1.9 This standard does not purport to address all of the
requirement options consistent with U.S. HHS NIOSH Na-
safety concerns, if any, associated with its use. It is the
tional Framework for Personal Protective Equipment Confor-
responsibility of the user of this standard to establish appro-
mity Assessment – Infrastructure as a means to manage the
priate safety, health, and environmental practices and deter-
risks to wearers to defined hazards from nonconforming PPE.
mine the applicability of regulatory limitations prior to use.
1.4 This guide identifies potential hazard and risk assess-
1.10 This international standard was developed in accor-
ment outcomes for which a conformity assessment scheme
dance with internationally recognized principles on standard-
(commonly referred to as a “program”) can be developed to
ization established in the Decision on Principles for the
manage assessed risks.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.5 It is not the intent of this guide to prescribe any
Barriers to Trade (TBT) Committee.
particular model of conformity assessment requirements for
PPE or its integral components.
2. Referenced Documents
1.6 The requirements and activities in a given conformity
3
2.1 ASTM Standards:
assessment scheme should be determined by a conformity
D123 Terminology Relating to Textiles
assessment scheme owner or can be defined by the PPE
F1494 Terminology Relating to Protective Clothing
specification standard writers, and should be based, at a
F2669 Performance Specification for Protective Clothing
minimum, on the criteria contained in Section 6 of this guide.
Worn by Operators Applying Pesticides
F2962 Practice for Conformity Assessment of Protective
1
This guide is under the jurisdiction of ASTM Committee F23 on Personal
Clothing Worn by Operators Applying Pesticides (With-
4
Protective Clothing and Equipment and is the direct responsibility of Subcommittee
drawn 2019)
F23.50 on PPE Conformity Assessment, Interoperability and Compatibility.
Current edition approved June 15, 2022. Published June 2022. Originally
approved in 2017. Last previous edition approved in 2022 as F3050 – 22. DOI:
3
10.1520/F3050-22A. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
2
Practice F2962 establishes the conformity assessment requirements for Speci- contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
fication F2669. This is an example for having conformity assessment requirements Standards volume information, refer to the standard’s Document Summary page on
in a PPE practice document related to a PPE specification standard. the ASTM website.
Co
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3050 − 22 F3050 − 22a
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
1.1 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
2
in a PPE specification standard or in 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 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
1
This guide is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee F23.50
on PPE Conformity Assessment, Interoperability and Compatibility.
Current edition approved Feb. 1, 2022June 15, 2022. Published February 2022June 2022. Originally approved in 2017. Last previous edition approved in 20212022 as
F3050 – 21.F3050 – 22. DOI: 10.1520/F3050-22.10.1520/F3050-22A.
2
Practice F2962 establishes the conformity assessment requirements for Specification F2669. This is an example for having conformity assessment requirements in a PPE
practice document related to a PPE specification standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F3050 − 22a
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.
2. Referenced Documents
3
2.1 ASTM Standards:
D123 Terminology Relating to Textiles
F1494 Terminology Relating to Protective Clothing
F2669 Performance Specification for Protective Clothing Worn by Operator
...
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