ASTM F3050-22a

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
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
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
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
This guide is under the jurisdiction of ASTM Committee F23 on Personal
Clothing Worn by Operators Applying Pesticides (With-
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:
10.1520/F3050-22A. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3050 − 22a
2.2 Federal Regulations: 3.1.7 conformity assessment, n—demonstration that speci-
CFR Title 21, Part 7, Subpart C Recall Procedures fied requirements relating to a product, process, system,
person, or body have been fulfilled. ISO/IEC 17000
2.3 ISO Standards:
ISO 9001:2015 Quality Management Systems – Require-
3.1.8 conformity assessment scheme, n—the specified con-
ments
formity assessment program’s rules, procedures, and require-
ISO/IEC 17000:2004 Conformity Assessment – Vocabulary
ments applied to completely assembled PPE, or individual
and General Principles
components, or subassemblies where required by a specifica-
ISO/IEC 17011:2004 General Requirements for Accredita-
tion. Adapted from ISO/IEC 17067
tion Bodies Accrediting Conformity Assessment Bodies
3.1.9 conformity assessment scheme owner, n—a person or
ISO/IEC 17025:2005 General Requirements for the Compe-
organization that has authority and responsibility for develop-
tence of Testing and Calibration Laboratories
ing and maintaining the conformity assessment scheme.
ISO/IEC 17065:2012 Requirements for Bodies Certifying
Adapted from ISO/IEC 17067
Products, Processes, and Services
3.1.10 evaluation, n—determination of the significance or
ISO/IEC 17067:2013 Fundamentals of Product Certification
condition by careful appraisal and study.
and Guidelines for Product Certification Schemes
ISO/IECTR 17026:2015 Example of a Certification Scheme 3.1.11 inspection, n—examination of a product, product
design, service, process, or manufacturing facility and deter-
for Tangible Products
mination of conformity with specific or (on the basis of
3. Terminology
professional judgment) general requirements. Adapted from
ISO/IEC 17000
3.1 Definitions:
3.1.1 accreditation, n—third-party attestation related to a
3.1.12 labeled, n—equipment or materials to which has
conformity assessment body conveying formal demonstration
been attached a label, symbol, or other identifying mark of an
of its competence to carry out specific conformity assessment
organization that is acceptable to the authority having jurisdic-
tasks. ISO/IEC 17000
tion and concerned with product evaluation, that maintains
periodic inspection of production of labeled equipment or
3.1.2 audit, n—systematic, independent, documented pro-
materials, and by whose labeling the personal protective
cess for getting records, statements of fact, or other relevant
equipment indicates conformance with designated specifica-
information and assessing them objectively to determine the
tions.
extent to which specified requirements are fulfilled. ISO/IEC
3.1.13 listed, n—equipment, materials, or services included
in a list published by an organization that is acceptable to the
3.1.3 certification, n—a system whereby a third-party inde-
authority having jurisdiction and concerned with evaluation of
pendent organization determines that a supplier has demon-
products or services, that maintains periodic inspection of
strated the ability to make a product that complies with the
production of listed equipment or materials or periodic evalu-
requirements of the specification, authorizes the supplier to use
ation of services, and whose listing states that either the
a label on products that comply with the requirements of the
equipment, material, or service meets appropriate designated
specification, and conducts a follow-up surveillance program
end-product specifications or has been tested and found suit-
to verify the methods the supplier uses to determine confor-
able for a specified purpose.
mance with the requirements of the specification. F1494
3.1.14 mark of conformity, n—legally registered certifica-
3.1.4 certification body, n—third-party conformity assess-
tion mark applied by or issued under the procedures of a
ment body operating certification schemes and attesting to the
third-party certification system for a product, process, or
conformity of products.
service that is in conformity with specific standards or other
3.1.4.1 Discussion—A certification body can be non-
technical specifications.
governmental or governmental (with or without regulatory
3.1.15 PPE, n—completely assembled personal protective
authority), and can also be known as “certification organiza-
clothing and equipment whose purpose is to provide a wearer
tions.”
personal protection from defined hazards.
3.1.5 certified product, n—product that has successfully
3.1.16 quality assurance, n—all the planned and systematic
been tested and found to conform by an appropriately accred-
activities implemented within the quality management system
ited certification body.
that can be demonstrated to provide evidence that a product or
3.1.6 certified product listing, n—a publicly accessible list-
service will fulfill claimed requirements with a verifiable and
ing of certified products.
high degree of confidence.
3.1.17 registration, n—the term (now retired) for the decla-
The last approved version of this historical standard is referenced on
ration by an accredited certification body that an organization
www.astm.org.
has demonstrated conformance with ISO 9001. A certification
Available from U.S. Government Printing Office, Superintendent of
(current term) is issued as the declaration of conformity to ISO
Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
www.access.gpo.gov.
9001.
Available from International Organization for Standardization (ISO), ISO
3.1.18 sample, n—(1) a portion of a lot of material which is
Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
Geneva, Switzerland, http://www.iso.org. taken for testing or for record purposes; (2) a group of
F3050 − 22a
specimens used, or observations made, which provide infor- surveillance, and quality and environmental system assessment
mation that can be used for making statistical inferences about and registration. It can also include accreditation that indicates
the population from which they were drawn. D123 competence by the provider from a third party.
5.4.1 The requirements’ rigor and scheme participant inde-
3.1.19 scheme owner, n—see conformity assessment scheme
pendenceoftheconformityassessmentactivitiescanvaryfrom
owner.
a supplier declaration of conformity (SDOC), to third-party
3.1.20 specimen, n—a specific portion of a material or a
independent testing, certification, and other conformity assess-
laboratory sample upon which a test is performed or which is
ment requirements.
selected for that purpose. D123
5.5 This guide identifies options for conformity assessment
3.1.21 supplier, n—the entity that directs and controls the
consistent with the U.S. HHS NIOSH National Framework for
following: conformant product design, conformant product
Personal Protective Equipment Conformity Assessment – In-
manufacturing, conformant product quality assurance; or the
frastructure as a means to manage the defined hazards and risk
entity that assumes the liability for the conformant product or
to wearers of a nonconforming PPE.
provides the warranty for the conformant product.
5.6 This guide further identifies hazards and risks for which
3.1.22 supplier declaration of conformity (SDOC), n—the
a conformity assessment scheme can be developed.
procedure by which a first party or supplier conveys assurance
that the object of conformity fulfills specified requirements.
6. Conformity Assessment – Requirements as Related to
3.1.23 surveillance, n—sampling, inspection, tests, or other
Risk
measures used on a periodic basis to determine the continued
6.1 Conformity assessment requirements should be tailored
conformanceofproductsthatarebeingmadebythesupplierto
to meet the needs of product suppliers, users, and regulatory
the requirements of the specification, or to assess the effective-
bodies.
ness of the conformity assessment scheme.
6.1.1 PPE specification requirements should clearly define
3.1.24 user, n—personororganizationwhomakesuseofthe
hazards for which the requirements are written to ensure
PPE; for example, one involved in selecting or maintaining the
conforming products provide adequate protection.
personal protective clothing and equipment for wearer protec-
6.1.2 The risk associated with nonconformance should in
tion from a defined hazard.
part determine decisions relative to the conformity require-
3.1.25 wearer, n—the person who wears the personal pro-
ments’rigor and participant independence needed in a confor-
tective clothing and equipment.
mity assessment scheme.
3.2 For definitions of other personal protective product-
6.1.3 Writers of CA requirements can use risk assessment
related terms used in this guide, refer to Terminology F1494.
methodsanddatatotheextentthatsuchareavailable;theyalso
apply professional judgment and experience. Examples of
4. Summary of Guide
safetyandhealthconsiderationsforassessinghazardsandrisks
are indicated in Table 1.
4.1 This guide is structured to identify conformity assess-
ment considerations and optional requirements related to
7. Conformity Assessment Schemes
personal protective clothing and equipment.
7.1 Conformity assessment schemes are a way to manage
5. Significance and Use
hazards and risks associated with a nonconforming product.
7.1.1 Conformity assessment scheme owners will define,
5.1 Writers of PPE specifications produce requirements to
operate, and monitor scheme performance and effectiveness,
mitigate defined personal safety and health hazards.
and adjust the requirements of the scheme. They will also
5.2 The users and wearers of PPE expect that these products
select PPE specifications to which a product should conform to
will perform in conformance with stated specifications to help
ensure that a product provides adequate protection for the
mitigate personal hazard(s).
defined hazard. For additional guidance, refer to ISO/IEC
5.3 Conformity assessment requirements are a means to
17067.
provide confidence that PPE conform to specifications.
7.2 Additional conformity assessment stakeholders can in-
5.3.1 Conformity assessment requirements should be de-
clude other organizations such as suppliers, purchasers, certi-
fined to address the confidence needed to ensure the PPE will
fication bodies, testing laboratories, regulatory bodies, trade
provide protection for the identified hazard. (See AnnexA1 for
associations, labor associations, standards-writing groups, etc.
adiscussiononhowstandardsshouldaddresshazardsandrisks
7.3 Standards-writing groups are encouraged to engage in a
through performance and other requirements that provide
adequate protection.) thorough and thoughtful discussion of the advantages and
disadvantages of independence and robustness of conformity
5.3.2 Conformity assessment requirements are a means to
manage the risks of nonconforming PPE and can serve as a assessment activities in order to provide proportional benefits
to the effort and cost associated. (See Annex A2 for questions
balance of cost effectiveness and risk of injury or illness of a
nonconforming product. that can inform this discussion.)
5.4 Conformity assessment can include sampling and 7.4 When conformity assessment requirements are defined
testing, inspection, supplier’s declaration, certification, in a PPE practice or specification, a scheme owner may be
F3050 − 22a
A
TABLE 1 Examples of Safety and Health Considerations for Assessing Hazards and Risks
Hazard/Risk Level
Considerations
Low Low/Medium Medium Medium/High High
Severity Injury or illness is not Injury or illness is not Serious injury is Serious injuries that are Life threatening; serious
serious but may include serious but may include reversible not life threatening but injuries; illness is
discomfort, skin discomfort, skin may not be reversible irreversible
irritations or abrasions, irritations or abrasions,
etc. etc.
Detectability Nonconformance can be Nonconformance may Nonconformance is not Nonconformance is not Nonconformance is not
detected prior to use be detected prior to use likely detectable prior to detectable prior to use detectable prior to use
when following supplier when following supplier use when following when following supplier when following supplier
instructions for instructions for supplier instructions for instructions for instructions for
inspection, evaluation, inspection, evaluation, inspection, evaluation, inspection, evaluation, inspection, evaluation,
or other suitable means or other suitable means or other suitable means or other suitable means or other suitable means
Medical Attention Not required Not required, but first Required, including first Required Required
aid may be necessary aid
Hospitalization Not required Not required May be required Required Required
Lost Wages or Time Off Does not occur May occur, but limited May occur, but limited May occur Occurs
Work
Probability of Low Low/Medium Medium Medium/High High
Occurrence
A
The severity considerations outlined in this table refer to acute hazards/risks only.
identified. Organizations serving as scheme owners may in- (f) Methods and procedures to be used by the conformity
cludecertificationbodies,regulatorybodies,tradeassociations,
assessment bodies and other organizations involved in the
labor associations, suppliers, etc. conformity assessment scheme that ensure the integrity and
consistency of the outcome of the conformity assessment
7.5 As a guide for developing a scheme, the following
processes,
considerations are helpful when identifying conformity assess-
(g) Information to be supplied to the various bodies in the
ment requirements:
scheme,
(1) Indicate the roles of various conformity assessment
(h) Content of the statement of conformity (for example,
bodies that may have a role within the conformity assessment
certificate) which unambiguously identifies the product to
scheme.
which it applies,
(2) A conformity assessment scheme may contain some of
(i) Conditionsunderwhichthestatementofconformityor
the following elements (source is ISO/IEC 17067 with modi-
marks of conformity are used, the ownership, use, and control
fications):
(a) Scope of the conformity assessment scheme, includ- of the marks,
ing the type of product(s) covered, (j) Resources required for the operation of the conformity
(b) All requirements against which the product(s) are assessment scheme, including impartiality and competence of
evaluated, including reference to standards or other normative the personnel (internal and external), the evaluation resources,
documents,
and the use of subcontractors,
(c) Selection of the activities appropriate to the confor- (k) Determination (evaluation) and surveillance stages to
mity assessment scheme,
be reported and used by the various conformity assessment
(d) Requirements associated with a quality management
bodies and by the scheme owner,
system and product quality control for ongoing production of
(l) Surveillance procedures,
product(s),
(m) Procedures for how nonconformities with the scheme
(e) Requirements for conformity assessment bodies in-
requirements, including product requirements, are to be dealt
cludingaccreditation(forexample,testinglaboratories,inspec-
with and resolved,
tionbodies,productcertificationbodies,bodiesauditingmanu-
(n) Criteriaforaccessbyconformityassessmentbodiesto
facturers’ management systems),
the conformity assessment scheme and for the access of clients
Note: The use of accredited conformity assessment bodies can allow for the to the scheme,
acceptance of test data or recognition of current certifications by conformity
(o) Content, conditions, and responsibility for publication
assessment bodies from other appropriate accredited conformity assessment
of the directory of products by various bodies and the scheme
bodies meeting all requirements.
owner,
(p) Content of various contracts including the rights,
responsibilities, and liabilities of the various parties within the
©ISO. This material is reproduced from ISO/IEC 17067:2013 with permission
scheme such as between scheme owner, clients, and confor-
of the American National Standards Institute (ANSI) on behalf of the International
Organization for Standardization. All rights reserved. mity assessment bodies,
F3050 − 22a
(q) General conditions for granting, maintaining, thatmitigationofhazardriskcanbedecreased.Thehazard/risk
continuing, extending the scope of, reducing the scope of, categories used in this guide categorize these aspects of risk
suspending, and withdrawing conformity declarations, includ- and associated hazard types.
ing requirements for discontinuation of advertising and return
8.3 Unrelated factors that can be addressed by training or
of conformity documents and any other action if the declara-
closer supervision, such as improper wearing of the device,
tion is suspended, withdrawn, or terminated,
using the wrong device for the hazard, using a poorly fitting
(r) Requirements for complaints records are to be verified
device, or not maintaining the device are not considered when
if such verification is part of the scheme,
establishing the overall hazard risk. Furthermore, the exercise
(s) Rights and obligations for public declarations, and
should be based on reasonably expected outcomes for typical
(t) Requirements for retention of records by scheme
use as defined by supplier use instructions.
owner and conformity assessment bodies.
8.4 Table A2.1, Conformity Assessment Example Models
(see Annex A2), provides a general association of assessed
8. Conformity Assessment Scheme Activities
hazard/risk with conformity assessment variation of indepen-
8.1 This guide identifies conformity assessment activities
dence and robustness. Examples of detailed conformity assess-
with robustness and independence relative to the hazards and
ment requirements relevant to each model are also contained in
risk assessment considerations specified in Section 6.
Annex A3. Other governmental regulations or national or
8.2 Establishment of overall risk is often not an exact international consensus standards (for example, ANSI/ISEA
125) may also be used to associate conformity assessment
exercise. Risk is commonly considered to include the dual
factors of likelihood of an event and seriousness of the activities to meet the assessed hazard/risk.
consequences of the event. For PPE wearers, subsequent
9. Keywords
outcomes such as the resultant health condition and resultant
loss of work are obvious factors. 9.1 certification; conformity assessment; hazard; personal
8.2.1 One consideration to make is whether the nonconfor- protective clothing and equipment; PPE; quality assurance;
mity is detectable by the wearer prior to or during use, such risk; supplier declaration; third-party testing
ANNEXES
(Mandatory Information)
A1. ADDRESSING HAZARDS THROUGH STANDARDS
A1.1 The NIOSH National Framework for PPE Conformity whichconnectsidentifiedhazardswithameasurableprotection
Assessment – Infrastructure provides recommendations and requirement.The conformity assessment scheme owner should
guidance for effective demonstration and attestation that PPE
understand whether the end product PPE specifications are
conforming to requirements provide adequate protection by
adequate in addressing specific hazards to define effective
addressing hazards and risks.
conformity assessment program activities. The example below
shows how a standard addresses hazards and associated pro-
A1.2 The requirements, as expressed in standards, identify
tection requirements.
the protection to which PPE must conform to sufficiently
ASTM Specification F1818 for Foot Protection for Chain Saw Users identifies
address the exposure to the hazard. They provide the link
the HAZARD from which conforming products are intended to protect by stating
between identified hazards and activities of conformity.
that “the objective of this specification is to prescribe [{] criteria for footwear and
Typically,thisisdoneinastandardthroughasimplestatement,
foot protective devices, worn by chain saw operators, which are intended to
reduce foot injuries caused by contact with a running power chain saw.” The
standard identifies the PROTECTION REQUIREMENTS necessary to in part
mitigate the risk to this hazard. Requirements include areas of protection for:
TheNIOSHNationalFrameworkforPPEConformityAssessment–Infrastruc-
•Height: “The chain saw cut resistance area of the upper test cut zone shall
ture provides guidance that can be appropriately tailored and universally applied to
extend downward from a minimum height of 178 mm (7 in.),” and
all PPE that protects from a variety of risks regardless of the hazard, type, or
•Toe area thickness and width: “Toe boxes at least 1.6 mm (0.60 in.).”
environment. The Framework report defines a process that contains five steps that
It also specifies performance requirements; such as:
link the elements of the well-developed public health hierarchy of controls with
•“The footwear shall demonstrate a minimum CS50 (the mean velocity at
those of CA. The report describes the foundational principles of CA to enable
which cut through occurs) of 13.9 m/s (2750 fpm),” or
program owners to define the independence and rigor of CArequirements based on
•“There shall be no cut through at 1.5 seconds when tested in accordance
risk to workers from a nonconforming product. The Framework is supported by a
with Test Method F1458.”
checklistthatprovidesguidancetoallowprospectiveCAschemeownerstoevaluate
and then define an approach specific to their workplace needs.
F3050 − 22a
A2. CONSIDERATIONS FOR DETERMINING CONFORMITY ASSESSMENT ACTIVITIES AND REQUIREMENTS
A2.1 In addition to the hazard/risk considerations discussed (5) How well would the current state of the industry,
in Table 1, Table A2.1 provides descriptions of example including the maturity of product design, manufacturing
conformity assessment models and how they can be applied
processes, and testing experience, support conformity assess-
based on the hazards/risks assessed. Standards-writing groups
ment schemes based on a manufacturer’s self-declaration?
are encouraged to engage in a thorough and thoughtful
How well has manufacturing self-declaration worked up to
discussion of the advantages and disadvantages of indepen-
now where it is currently allowed and widely used, and can
dence and robustness of conformity assessment processes
similar performance of self-declaration techniques be reason-
required to meet hazard/risk assessed. Conformity assessment
ably expected going forward?
activities with greater independence and robustness can some-
(6) How might requirements for greater independence and
times have unintended negative consequences, including being
robustness of conformity assessment activities affect the avail-
time consuming and expensive, and may not deliver propor-
ability of a variety of sizes, fits, and styles of product?
tional benefits to the user community. Conversely, conformity
(7) Will increased independence and robustness of confor-
assessment activities with less independence and robustness,
mity assessment curb the distribution of fraudulently labeled
while cost effective, are reliant on claims from the manufac-
goods? If so, who will police the market?
turer and may not be robust enough to serve an industry’s
(8) Can the current testing or certification infrastructure (or
specific needs.
both), including the existence and availability of equipment
A2.2 When deciding on a CA program, discussion should and trained personnel both in commercial labs and within
include a range of topics such as the following:
manufacturing organizations, support a contemplated confor-
(1) Are there issues with nonconformity of current prod-
mity assessment scheme?
ucts in the field? Have these issues jeopardized wearer safety?
(9) Does the relevant performance standard provide guid-
(2) What would be the costs or burdens to producers and
anceonhowtoproperlylabelcertifiedproducts?Ifnot,canthe
users of any imposed conformity assessment scheme?
standard be revised within a reasonable time to accommodate
(3) Does the market of interest currently demand greater
labeling for appropriate conformity assessment independence
conformity assessment, including fully certified products?
and robustness?
(4) Howwouldthevariousconformityassessmentschemes
benefit users? Do these benefits include improved safety? Are
there benefits to users besides safety?
TABLE A2.1 Conformity Assessment Example Models
Example Conformity Assessment (CA) Models
Conformity Activity
(Increased confidence requires increased cost and resources)
CA Model Designation A A1 B C D
Associated Risk/Hazard Low Low/Medium Medium Medium/High High
Attestation Supplier Supplier Supplier Certification body (CB) Certification body (CB)
Attester Qualifications Supplier establishes Supplier establishes SDOC meets ISO/IEC CB is accredited to ISO/ CB is accredited to ISO/
requirements requirements 17050, Parts1&2 IEC 17065 IEC 17065
Testing and Inspection Independence Independence Independence Independence Independence
Supplier establishes Supplier establishes Supplier establishes CB establishes Third party only
Robustness Robustness Robustness Robustness Robustness
Supplier establishes Testing Laboratory (TL) TL is accredited to ISO/ TL is accredited to ISO/ TL is accredited to ISO/
is accredited to ISO/IEC IEC 17025 IEC 17025 IEC 17025
Quality Management Supplier maintains a Supplier maintains a Supplier maintains a Supplier maintains a Supplier maintains a
System (QMS) QMS with appropriate QMS with appropriate QMS with ISO 9001 ac- QMS with ISO 9001 ac- QMS with ISO 9001 ac-
scope scope creditation and appropri- creditation and appropri- creditation and appropri-
ate scope ate scope; additional CB ate scope; additional CB
requirements requirements
Ongoing Conformity Supplier monitors con- Supplier monitors con- Supplier monitors con- CB establishes surveil- CB establishes
formity and ensures formity and ensures formity and ensures lance surveillance
product changes result product changes result product changes result
in retesting or inspection in retesting or inspection in retesting or inspection
F3050 − 22a
A3. GUIDANCE TO RELATE RISK TO CONFORMITY ASSESSMENT ACTIVITIES
NOTE A3.1—This Annex contains examples of conformity assessment
(8) Signature, name, and function of the person making the
requirements that may be used by standards writers to express conformity
declaration.
assessment requirements related to a specification standard. The example
A3.1.2.2 The supplier shall supply the following additional
requirements of each model may be used in part or in total.As examples,
information if applicable:
these conformity assessment requirements use the terms SHALL,
(1) Name and address of any testing laboratories or certi-
SHOULD, and MAY. The use of SHALL does not denote a mandatory
requirement in this guide; rather it indicates that if the example require-
fication bodies involved,
ment is used in relation to a specification standard, this guide recommends
(2) References to relevant test reports and the date of such
that it be a mandatory requirement.
reports, and
(3) Additional information regarding certifications or reg-
A3.1 Conformity Assessment – Models of Conformity –
istrations that have been obtained.
Model A Requirements (See Table A2.1)
A3.1.3 Testing/Inspection Facility and Criteria:
A3.1.1 General:
A3.1.3.1 For declarations of conformity, the supplier shall
A3.1.1.1 The supplier declaration of conformity (SDOC) is
conduct or have conducted on their behalf both inspection and
written as a declarative statement and clearly states that the
testing as specified in this section.
product conforms to the complete specification unless the
A3.1.3.2 All inspections, conditioning, and testing for dec-
specificationallowsforclaimsofasubsetofrequirements.The
laration of conformity shall be conducted by the supplier or on
supplier shall meet the requirements of A3.1, including all
behalf of the supplier in a testing laboratory.
subsections.
A3.1.3.3 The supplier shall be permitted to utilize condi-
A3.1.1.2 The supplier shall not claim conformity with
tioning and testing results conducted by a product or compo-
portions or segments of the requirements of any PPE specifi-
nent supplier for declarations of conformity.
cation unless explicitly allowed by the PPE specification.
A3.1.3.4 Sampling for testing and inspection shall be estab-
A3.1.1.2.1 TheASTM name or the name or identification of
lished by the supplier to ensure confidence that the end product
the PPE specification shall not be used in any supplier
complies to the specification, unless such sampling is specified
statements about their respective product(s) when conformity
therein.
is to only portions of the specification unless explicitly allowed
NOTE A3.2—It is the responsibility of the supplier to determine
by the PPE specification.
sampling requirements based on production volume.
A3.1.1.2.2 Component suppliers may claim conformity
A3.1.3.5 Inspection shall include a review of the user
with portions or segments of the requirements of a PPE
information required in the User Information section of the
specification provided the component requirements are clearly
PPE specification to ensure that the information has been
defined with the PPE specification and the PPE specification
developed and is available.
permits such claims.
A3.1.3.6 Inspection for determining conformity with the
A3.1.1.3 The supplier shall be responsible for issuing,
design requirements specified in the Design Requirements of
maintaining, and withdrawing a declaration of conformity.
the PPE specification shall be performed on whole or complete
A3.1.1.4 All items that are part of the declaration of
products.
conformity and are labeled as being conformant with a PPE
A3.1.3.7 Testing to determine product conformity with the
specification or components conformant with applicable por-
performance requirements specified in the Performance Re-
tions or segments of the PPE specification shall meet or exceed
quirements section of the PPE specification shall be conducted
all applicable requirements in the PPE specification.
inaccordancewiththespecifiedtestingrequirementsofthetest
A3.1.2 Supplier Declaration of Conformity (SDOC): methods identified in the PPE specification.
A3.1.3.7.1 Testing shall be performed on samples with
A3.1.2.1 The supplier shall supply the following informa-
specimens representative of materials and components used in
tion in the declaration of conformity:
the construction of the item.
(1) Unique identification number of the declaration of
A3.1.3.7.2 Sample materials cut from a representative prod-
conformity,
uct shall be permitted to be used for evaluation.
(2) Name and address of the issuer (supplier) of the
A3.1.3.8 The supplier shall test only products or product
declaration of conformity,
(3) Identification (model name or part number) of the item components that are the same in every respect as the actual
final product or product component.
of the declaration of conformity,
(4) Statement of conformity, A3.1.3.9 No modifications, pretreatment, conditioning, or
(5) IdentificationofthePPEspecificationnumber,title,and other such special processes of the product or any product
edition, componentpriortotheproduct’sevaluationandtestingshallbe
(6) Test dates for all performance tests, permitted unless specified in the test methods of the PPE
(7) Date of issue of the declaration of conformity, and specification.
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A3.1.3.10 No substitution, repair, or modification, other A3.1.8.3 Inspection shall include a review of all product
than as specifically permitted herein, of any product or any labels to ensure that all required label attachments, confor-
product component during testing shall be permitted. mance statements, and other product information are at least as
A3.1.3.11 Test specimens that have been conditioned and specified for the item in the Labeling Requirements section of
tested for one method shall not be reconditioned and tested for the PPE specification.
another test method unless specifically permitted in the test A3.1.8.4 Inspection shall include an evaluation of any
method.
symbols and pictorial representations used on product labels or
in user information, as permitted by the PPE specification, to
A3.1.4 Quality Management System:
ensure that the symbols are clearly explained in the product’s
A3.1.4.1 The supplier shall maintain a quality management
user information package.
system with a scope that includes the manufacture of the
product to which conformity is affirmed. The quality manage-
A3.2 Conformity Assessment – Models of Conformity –
ment system shall ensure initial and ongoing conformity to the
Model A1 Requirements (see Table A2.1)
PPE specification to which attestation of conformity is made.
A3.2.1 General:
A3.1.5 Record Retention:
A3.2.1.1 The supplier declaration of conformity (SDOC) is
A3.1.5.1 The supplier shall maintain or cause to be main-
written as a declarative statement and clearly states that the
tained by subcontractors all design, performance, inspection,
product conforms to the complete specification unless the
and test data used for the declaration of conformity. The
specificationallowsforclaimsofasubsetofrequirements.The
suppliershallprovidetestdatauponrequesttothepurchaseror
supplier shall meet the requirements of A3.2, including all
authority having jurisdiction.
subsections.
A3.1.5.2 The supplier shall keep or cause to be maintained
A3.2.1.2 The supplier shall not claim conformity with
by the subcontractor all required technical documentation for
portions or segments of the requirements of any PPE specifi-
the minimum period required by the conformity assessment
cation unless explicitly allowed by the PPE specification.
scheme owner or specified in the PPE specification after the
A3.2.1.2.1 TheASTM name or the name or identification of
last of the personal protective equipment has been manufac-
the PPE specification shall not be used in any supplier
tured.
statements about their respective product(s) when conformity
A3.1.6 Ongoing Conformity:
is to only portions of the specification unless explicitly allowed
A3.1.6.1 The supplier shall establish and maintain a correc-
by the PPE specification.
tive and preventive action plan.
A3.2.1.2.2 Component suppliers may claim conformity
A3.1.6.2 The supplier shall evaluate any changes affecting
with portions or segments of the requirements of a PPE
the form, fit, or function of the product to determine its
specification provided the component requirements are clearly
continued conformity to the PPE specification.
defined with the PPE specification and the PPE specifications
A3.1.6.3 Anychangeinthedesign,construction,ormaterial
permits such claims.
of a product shall necessitate new inspection and testing to
A3.2.1.3 The supplier shall be responsible for issuing,
verify conformity to all applicable requirements of the PPE
maintaining, and withdrawing a declaration of conformity.
specification. This validation shall be conducted before label-
A3.2.1.4 All items that are part of the declaration of
ing the modified product as being conformant with the PPE
conformity and are labeled as being conformant with a PPE
specification.
specification or components conformant with applicable por-
A3.1.6.4 Any revision to the PPE specification to which the
tions or segments of the PPE specification shall meet or exceed
product was evaluated shall necessitate new inspection and
all applicable requirements in the PPE specification.
testing to verify conformity to all applicable requirements of
A3.2.2 Supplier Declaration of Conformity (SDOC):
the PPE specification. This validation shall be conducted
A3.2.2.1 The supplier shall supply the following informa-
before labeling the modified product as being conformant with
tion in the declaration of conformity:
the PPE specification. The time frame for revalidation and
(1) Unique identification number of the declaration of
relabeling may be specified by the conformity assessment
conformity,
scheme owner or specified in the PPE specification.
(2) Name and address of the issuer (supplier) of the
A3.1.7 Recalls and Safety Alerts:
declaration of conformity,
A3.1.7.1 The supplier shall have in place a documented
(3) Identification (model name or part number) of the item
productrecallprocessaspartofitsqualitymanagementsystem
of the declaration of conformity,
to be used in the event that the personal protective equipment
(4) Statement of conformity,
supplier decides, or is required by the certification body, to
(5) IdentificationofthePPEspecificationnumber,title,and
issue a product recall.
edition,
A3.1.8 Mark/Logo: (6) Test dates for all performance tests,
A3.1.8.1 All conformant items shall have a product label (7) Date of issue of the declaration of conformity, and
(8) Signature, name, and function of the person making the
that meets the requirements specified in the PPE specification.
A3.1.8.2 The supplier’s name and address shall be attached declaration.
to the product label, shall be part of the product label, or shall A3.2.2.2 The supplier shall supply the following additional
be immediately adjacent to the product label. information if applicable:
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(1) Name and address of any testing laboratories or certi- A3.2.3.12 Test specimens that have been conditioned and
fication bodies involved, tested for one method shall not be reconditioned and tested for
(2) References to relevant test reports and the date of such another test method unless specifically permitted in the test
reports, and method.
(3) Additional information regarding certifications or reg-
A3.2.4 Quality Management System:
istrations that have been obtained.
A3.2.4.1 The supplier shall maintain a quality management
system with a scope that includes the manufacture of the
A3.2.3 Testing/Inspection Facility and Criteria:
product to which conformity is affirmed. The quality manage-
A3.2.3.1 For declarations of conformity, the supplier shall
ment system shall ensure initial and ongoing conformity to the
conduct or have conducted on their behalf both inspection and
PPE specification to which attestation of conformity is made.
testing as specified in this section.
A3.2.3.2 All inspections, conditioning, and testing for dec- A3.2.5 Records Retention:
larationsofconformityshallbeconductedbythesupplieroron
A3.2.5.1 The supplier shall maintain or cause to be main-
behalf of the supplier in a testing laboratory. The testing tained by subcontractors all design, performance, inspection,
laboratory shall be accredited to ISO/IEC 17025 by an accredi- and test data used for the declaration of conformity. The
tation body that is a signatory to the ILAC. The scope of suppliershallprovidetestdatauponrequesttothepurchaseror
accreditation shall include the test being conducted or the authority having jurisdiction.
product performance standard applicable to the product being
A3.2.5.2 The supplier shall keep or cause to be maintained
tested. by the subcontractor all required technical documentation for
the minimum period required by the conformity assessment
A3.2.3.3 The supplier shall be permitted to utilize condi-
scheme owner or specified in the PPE specification after the
tioning and testing results conducted by a product or compo-
last of the personal protective equipment has been manufac-
nent supplier, provided the laboratory generating results meets
tured.
the requirements of A3.2.3.2.
A3.2.3.4 Sampling for testing and inspection shall be estab-
A3.2.6 Ongoing Conformity:
lished by the supplier to en
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