1、Designation: F3050 17Standard Guide forConformity Assessment of Personal Protective Clothing andEquipment1This standard is issued under the fixed designation F3050; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last r
2、evision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide describes options for conformity assessment(CA) requirements relating to personal protective clothing andequipmen
3、t (hereafter referred to as “PPE”). This guidance canoptionally be used to define conformity assessment require-ments in a PPE specification standard or in a companionASTMconformity assessment Standard Practice document2associatedwith the PPE specification standard. It is understood that theformer a
4、pproach is not consistent with ISO Directive, Part 2,Section 6.7.1.2 This guide is not intended to require additional confor-mity assessment requirements to any PPE specification stan-dard or to the integral components of the PPE.1.3 This guide defines conformity assessment principles andrequirement
5、 options consistent with U.S. HHS NIOSH Na-tional Framework for Personal Protective Equipment Con-formity Assessment Infrastructure as a means to manage therisks to wearers to defined hazards from nonconforming PPE.1.4 This guide identifies potential hazard and risk assess-ment outcomes for which a
6、conformity assessment scheme(commonly referred to as a “program”) can be developed tomanage assessed risks.1.5 It is not the intent of this guide to prescribe anyparticular model of conformity assessment requirements forPPE or its integral components.1.6 The requirements and activities in a given co
7、nformityassessment scheme should be determined by a conformityassessment scheme owner or can be defined by the PPEspecification standard writers, and should be based, at aminimum, on the criteria contained in Section 6 of this guide.1.7 This guide is not intended to supersede any federal,state, or l
8、ocal laws or regulations.1.8 This guide offers an organized collection of informationor a series of options and does not recommend a specific courseof action. This document cannot replace education or experi-ence and should be used in conjunction with professionaljudgment. Not all aspects of this gu
9、ide may be applicable in allPPE circumstances. This ASTM guide is not intended torepresent or replace the standard of care by which the adequacyof a given professional service must be judged, nor should thisdocument be applied without consideration of a projects manyunique aspects. The word “standar
10、d” in the title of thisdocument means only that the document has been approvedthrough the ASTM consensus process.1.9 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate sa
11、fety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:3D123 Terminology Relating to TextilesF1494 Terminology Relating to Protective ClothingF2669 Performance Specification for Protective ClothingWorn by Operators
12、Applying PesticidesF2962 Practice for Conformity Assessment of ProtectiveClothing Worn by Operators Applying Pesticides2.2 Federal Regulations:4CFR Title 21, Part 7, Subpart C Recall Procedures2.3 ISO Standards:5ISO 9001:2015 Quality Management Systems Require-mentsISO/IEC 17000:2004 Conformity Asse
13、ssment Vocabularyand General Principles1This guide is under the jurisdiction of ASTM Committee F23 on PersonalProtective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.50 on Certification and PPE Interoperability.Current edition approved March 1, 2017. Published March 201
14、7. Originallyapproved in 2017. DOI: 10.1520/F3050-17.2Practice F2962 establishes the conformity assessment requirements for Speci-fication F2669. This is an example for having conformity assessment requirementsin a PPE practice document related to a PPE specification standard.3For referenced ASTM st
15、andards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Available from U.S. Government Printing Office, Superintendent ofDocuments, 732 N.
16、Capitol St., NW, Washington, DC 20401-0001, http:/www.access.gpo.gov.5Available from International Organization for Standardization (ISO), ISOCentral Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.Copyright ASTM International, 100 Barr Harbo
17、r Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendatio
18、ns issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1ISO/IEC 17011:2004 General Requirements for Accredita-tion Bodies Accrediting Conformity Assessment BodiesISO/IEC 17025:2005 General Requirements for the Compe-tence of Testing and Calibration LaboratoriesISO/IEC
19、17065:2012 Requirements for Bodies CertifyingProducts, Processes, and ServicesISO/IEC 17067:2013 Fundamentals of Product Certificationand Guidelines for Product Certification SchemesISO/IEC TR 17026:2015 Example of a Certification Schemefor Tangible Products3. Terminology3.1 Definitions:3.1.1 accred
20、itation, nthird-party attestation related to aconformity assessment body conveying formal demonstrationof its competence to carry out specific conformity assessmenttasks. ISO/IEC 170003.1.2 audit, nsystematic, independent, documented pro-cess for getting records, statements of fact, or other relevan
21、tinformation and assessing them objectively to determine theextent to which specified requirements are fulfilled. ISO/IEC170003.1.3 certification, na system whereby a third party inde-pendent organization determines that a supplier has demon-strated the ability to make a product that complies with t
22、herequirements of the specification, authorizes the supplier to usea label on products that comply with the requirements of thespecification, and conducts a follow-up surveillance programto verify the methods the supplier uses to determine confor-mance with the requirements of the specification. F14
23、943.1.4 certification body, nthird-party conformity assess-ment body operating certification schemes and attesting to theconformity of products.3.1.4.1 DiscussionA certification body can be non-governmental or governmental (with or without regulatoryauthority), and can also be known as “certificatio
24、n organiza-tions.”3.1.5 certified product, nproduct that has successfullybeen tested and found to conform by an appropriately accred-ited certification body.3.1.6 certified product listing, na publicly accessible list-ing of certified products.3.1.7 conformity assessment, ndemonstration that speci-f
25、ied requirements relating to a product, process, system,person, or body have been fulfilled. ISO/IEC 170003.1.8 conformity assessment scheme, nthe specified con-formity assessment programs rules, procedures, and require-ments applied to completely assembled PPE, or individualcomponents, or subassemb
26、lies where required by a specifica-tion. Adapted from ISO/IEC 170673.1.9 conformity assessment scheme owner, na person ororganization that has authority and responsibility for develop-ing and maintaining the conformity assessment scheme.Adapted from ISO/IEC 170673.1.10 evaluation, ndetermination of
27、the significance orcondition by careful appraisal and study.3.1.11 inspection, nexamination of a product, productdesign, service, process, or manufacturing facility and deter-mination of conformity with specific or (on the basis ofprofessional judgment) general requirements. Adapted fromISO/IEC 1700
28、03.1.12 labeled, nequipment or materials to which hasbeen attached a label, symbol, or other identifying mark of anorganization that is acceptable to the authority having jurisdic-tion and concerned with product evaluation, that maintainsperiodic inspection of production of labeled equipment ormater
29、ials, and by whose labeling the personal protectiveequipment indicates conformance with designated specifica-tions.3.1.13 listed, nequipment, materials, or services includedin a list published by an organization that is acceptable to theauthority having jurisdiction and concerned with evaluation ofp
30、roducts or services, that maintains periodic inspection ofproduction of listed equipment or materials or periodic evalu-ation of services, and whose listing states that either theequipment, material, or service meets appropriate designatedend-product specifications or has been tested and found suit-
31、able for a specified purpose.3.1.14 mark of conformity, nlegally registered certifica-tion mark applied by or issued under the procedures of athird-party certification system for a product, process, orservice that is in conformity with specific standards or othertechnical specifications.3.1.15 PPE,
32、ncompletely assembled personal protectiveclothing and equipment whose purpose is to provide a wearerpersonal protection from defined hazards.3.1.16 quality assurance, nall the planned and systematicactivities implemented within the quality management systemthat can be demonstrated to provide evidenc
33、e that a product orservice will fulfill claimed requirements with a verifiable andhigh degree of confidence.3.1.17 registration, nthe term (now retired) for the decla-ration by an accredited certification body that an organizationhas demonstrated conformance with ISO 9001. A certification(current te
34、rm) is issued as the declaration of conformity to ISO9001.3.1.18 sample, n(1) a portion of a lot of material which istaken for testing or for record purposes; (2) a group ofspecimens used, or observations made, which provide infor-mation that can be used for making statistical inferences aboutthe po
35、pulation from which they were drawn. D1233.1.19 scheme owner, nsee conformity assessment schemeowner.3.1.20 specimen, na specific portion of a material or alaboratory sample upon which a test is performed or which isselected for that purpose. D1233.1.21 supplier declaration of conformity (SDOC), nth
36、eprocedure by which a first party or supplier conveys assurancethat the object of conformity fulfills specified requirements.3.1.22 supplier, nthe entity that directs and controls thefollowing: conformant product design, conformant productF3050 172manufacturing, conformant product quality assurance;
37、 or theentity that assumes the liability for the conformant product orprovides the warranty for the conformant product.3.1.23 surveillance, nsampling, inspection, tests, or othermeasures used on a periodic basis to determine the continuedconformance of products that are being made by the supplier to
38、the requirements of the specification, or to assess the effective-ness of the conformity assessment scheme.3.1.24 user, nperson or organization who makes use of thePPE; for example, one involved in selecting or maintaining thepersonal protective clothing and equipment for wearer protec-tion from a d
39、efined hazard.3.1.25 wearer, nthe person who wears the personal pro-tective clothing and equipment.3.2 For definitions of other personal protective product-related terms used in this guide, refer to Terminology F1494.4. Summary of Guide4.1 This guide is structured to identify conformity assess-ment
40、considerations and optional requirements related topersonal protective clothing and equipment.5. Significance and Use5.1 Writers of PPE specifications produce requirements tomitigate defined personal safety and health hazards.5.2 The users and wearers of PPE expect that these productswill perform in
41、 conformance with stated specifications to helpto mitigate personal hazard(s).5.3 Conformity assessment requirements are a means toprovide confidence that PPE conform to specifications.5.3.1 Conformity assessment requirements should be de-fined to address the confidence needed to ensure the PPE will
42、provide protection for the identified hazard. (See Annex A1 fora discussion on how standards should address hazards and risksthrough performance and other requirements that provideadequate protection.)5.3.2 Conformity assessment requirements are a means tomanage the risks of nonconforming PPE and ca
43、n serve as abalance of cost effectiveness and risk of injury or illness of anonconforming product.6. Conformity Assessment Requirements as Related toRisk6.1 Conformity assessment is defined as the demonstrationthat specified requirements relating to a product, process,system, person, or body are ful
44、filled.6.1.1 Conformity assessment can include sampling andtesting, inspection, suppliers declaration, certification,surveillance, and quality and environmental system assessmentand registration. It can also include accreditation that indicatescompetence by the provider from a third party.6.1.2 This
45、 guide identifies options for conformity assess-ment consistent with the U.S. HHS NIOSH National Frame-work for Personal Protective Equipment A ConformityAssessment Infrastructure as a means to manage the definedhazards and risk to wearers of a nonconforming PPE.6.1.3 The requirements rigor and sche
46、me participant inde-pendence of the conformity assessment activities can vary froma supplier declaration of conformity (SDOC), to third-partyindependent testing, certification, and other conformity assess-ment requirements.6.1.4 This guide further identifies hazards and risks forwhich a conformity a
47、ssessment scheme can be developed.6.2 Conformity assessment requirements should be tailoredto meet the needs of product suppliers, users, and regulatorybodies.6.2.1 PPE specification requirements should clearly definehazards for which the requirements are written to ensureconforming products provide
48、 adequate protection.6.2.2 The risk associated with nonconformance should inpart determine decisions relative to the conformity require-ments rigor and participant independence needed in a confor-mity assessment scheme.6.2.3 Writers of CA requirements can use risk assessmentmethods and data to the e
49、xtent that such are available; they alsoapply professional judgment and experience. Examples ofsafety and health considerations for assessing hazards and risksare indicated below:High Hazard/Risk Considerations:(1) Severity Life threatening or serious injuries orillnesses are irreversible.(2) Detectability Nonconformance cannot be detectedprior to use following supplier instructions for inspection,evaluation, or other suitable means.(3) Medical attention Required to care of critical injuryor serious illness.(4) Hospitalization Require
