ASTM E3108-2018 Standard Practice for Conformity Assessment of Protective Gloves Worn by Law Enforcement and Corrections Officers.pdf

1、Designation: E3108 18Standard Practice forConformity Assessment of Protective Gloves Worn by LawEnforcement and Corrections Officers1This standard is issued under the fixed designation E3108; the number immediately following the designation indicates the year oforiginal adoption or, in the case of r

2、evision, the year of last revision. 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 practice establishes the conformity assessmentrequirements for protective gloves worn by law

3、 enforcementand corrections officers. It was developed based on end userinput regarding hazards of concern and operational require-ments of officers.21.2 This practice provides two options for conformity as-sessment: (1) suppliers declaration of conformity (SDOC) and(2) certification.1.2.1 This prac

4、tice is intended to be used by purchasers andsuppliers in the procurement of gloves that meet SpecificationE3109, and the purchaser is responsible for selecting eitherSDOC or certification.NOTE 1An ASTM guide is being developed to provide agencies andend users with information related to the selecti

5、on, procurement, and useof protective gloves worn by law enforcement and corrections officerswhile on duty.1.2.2 The performance, testing, labeling, documentation,and reporting requirements for SDOC and for certification arespecified in Specification E3109.1.3 This standard does not purport to addre

6、ss all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.4 This international standard was develo

7、ped in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Docum

8、ents2.1 ASTM Standards:3NOTE 2For dated references, only the edition cited applies to preventunanticipated changes in test method procedures. For undated references,the latest edition of the referenced document applies, including anyamendments.E3109 18 Specification for Protective Gloves Worn byLaw

9、Enforcement and Corrections OfficersF1494 14 Terminology Relating to Protective ClothingF3050 17 Guide for Conformity Assessment of PersonalProtective Clothing and Equipment2.2 ISO/IEC Standards:4ISO 9000 Quality Management Systems Fundamentalsand VocabularyISO 9001 Quality Management Systems Requir

10、ementsISO/IEC 17000 Conformity Assessment Vocabulary andGeneral PrinciplesISO/IEC 17011 Conformity Assessment General Require-ments for Accreditation Bodies Accrediting ConformityAssessment BodiesISO/IEC 17025 General Requirements for the Competenceof Testing and Calibration LaboratoriesISO/IEC 1705

11、0-1 Conformity Assessment Suppliers Dec-laration of Conformity Part 1: General RequirementsISO/IEC 17050-2 Conformity Assessment Suppliers Dec-laration of Conformity Part 2: Supporting Documenta-tionISO/IEC 17065 Conformity Assessment Requirements forBodies Certifying Products, Processes, and Servic

12、es3. Terminology3.1 Definitions:1This practice is under the jurisdiction of ASTM Committee E54 on HomelandSecurity Applications and is the direct responsibility of Subcommittee E54.04 onPersonal Protective Equipment (PPE).Current edition approved June 1, 2018. Published July 2018. DOI: 10.1520/E3108

13、-18.2Guide F3050 provides considerations for performing a risk assessment.3For referenced ASTM standards, 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

14、ASTM website.4Available 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 Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959.

15、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 Recommendations issued by the World Trade Organization Technical Barr

16、iers to Trade (TBT) Committee.13.1.1 accreditation, nthird-party attestation related to aconformity assessment body conveying formal demonstrationof its competence to carry out specific conformity assessmenttasks. ISO/IEC 170003.1.2 auditsystematic, independent, documented processfor obtaining recor

17、ds, statements of fact or other relevantinformation 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

18、 to make a product that complies with therequirements 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

19、 requirements of the specification.Terminology F14943.1.4 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 regulatory

20、authority), and can also be known as a certification organiza-tion.3.1.5 certified product, nany product that has successfullybeen tested and found to conform by an appropriately accred-ited certification body.3.1.6 certified product listinga publicly accessible listingof certified products.3.1.7 co

21、nformity assessment, ndemonstration that speci-fied requirements relating to a product, process, system,person, or body are fulfilled. ISO/IEC 170003.1.8 evaluation, ndetermination of the significance orcondition by careful appraisal and study.3.1.9 inspection, nexamination of a product design,produ

22、ct, process or installation and determination of its con-formity with specific requirements or, on the basis of profes-sional judgment, with general requirements.ISO/IEC 170003.1.10 listed, adjincluded in a publicly accessible listpublished by an accredited certification body.3.1.11 model, nthe manu

23、facturers design, with uniquespecifications and characteristics, of a particular item.3.1.12 product, none unit of a particular model.3.1.13 supplier, nthe entity that directs and controls thefollowing: conformant product design, conformant productmanufacturing, conformant product quality assurance;

24、 or theentity that assumes the liability for the conformant product orprovides the warranty for the conformant product.3.1.14 suppliers declaration of conformity (SDOC), nthedeclaration by which a first party or supplier conveys assurancethat the object of conformity fulfills specified requirements.

25、ISO/IEC 170003.1.15 surveillance, nsystematic iteration of conformityassessment activities as a basis for maintaining the validity ofthe statement of conformity. ISO/IEC 170003.1.16 third-party, nindependent of the person or organi-zation that provides the product and of the user interests in thatob

26、ject.3.1.17 third-party certification, nconformity assessmentactivity that is performed by a person or body that is indepen-dent of the person or organization that provides the object andof user interests in that object.4. Suppliers Declaration of Conformity4.1 This section specifies requirements th

27、at apply when theoption of suppliers declaration of conformity (SDOC) isselected.4.2 The supplier shall provide an SDOC that meets theminimum requirements of ISO/IEC 17050-1 and SpecificationE3109. The SDOC shall include:4.2.1 Identification of what the declaration covers (forexample, model descript

28、ion; inspection, audit, and testing).4.2.2 Identification of applicable standard that the declara-tion is based on.4.2.3 Date and place of issue of the declaration of confor-mity.4.2.4 Any limitation on the validity of the declaration.4.3 The supporting documentation for the SDOC shall meetthe minim

29、um requirements of ISO/IEC 17050-2 including:4.3.1 A description of the object of the SDOC.4.3.2 The conformity assessment results such as descriptionof the method used to determine conformity, the actual results,and records on the evaluation of those results which led to thedeclaration of conformit

30、y.4.3.3 A test report, such as the example shown in AppendixX1. The supplier shall maintain a copy of the test report in itsrecords management system.4.4 Any material configuration changes that impact theperformance of the model shall require re-testing of the model.4.5 The supplier shall be respons

31、ible for having the testingdone.NOTE 3Testing may be done by the manufacturer, by the supplier, orby a third-party laboratory.4.6 The supplier shall only claim compliance with theportions of Specification E3109 that are met by the glovemodel.5. Product Certification5.1 This section specifies require

32、ments that apply when theoption of certification is selected.5.2 The certification body shall assess glove models forconformance with Specification E3109.5.2.1 The certification body shall provide a certificationreport that includes the documentation and labeling informa-tion specified in Specificat

33、ion E3109.5.3 The certification body shall assign distinct certificationidentification for each model of glove certified.E3108 1825.4 The certification bodys label, symbol, or identifyingmark of conformity and code assigned to the certified gloveshall be part of the product label or shall be immedia

34、telyadjacent to the product label.5.5 The certification body shall only authorize a supplier toclaim performance ratings for advertised protective areas ofgloves for which the glove model has been tested in confor-mance with the portions of Specification E3109.5.5.1 The certification body shall only

35、 authorize a supplierto use a label or reference to the certification body on productsfor which the model has been found to be compliant withapplicable requirements of Specification E3109.5.6 The certification body shall be accredited by an Inter-national Accreditation Forum Multilateral Recognition

36、 Ar-rangement (IAF MLA) signatory, for the scope of personalprotective equipment, in accordance with ISO/IEC 17065 andshall meet the requirements of this practice.5.7 Testing shall be conducted by an independent laboratorythat is accredited to ISO/IEC 17025 by an InternationalLaboratory Accreditatio

37、n Cooperation Mutual RecognitionArrangement (ILAC MRA) signatory accreditation body andshall have Specification E3109 listed in its scope of accredita-tion.5.8 The certification body shall not be owned or controlledby suppliers or vendors of the product being certified.5.9 The certification body sha

38、ll make publicly available alisting of all products which it has certified to SpecificationE3109.5.10 The certification body shall require the supplier tosubmit specific details on any proposed change(s) to a certifiedmodel prior to implementation of a change. The certificationbody shall evaluate th

39、e change(s) to determine the impact tothe model and whether testing shall be required to demonstratecontinued compliance.6. Documentation, Product Label, and Package Label6.1 Documentation, product labels, and package labels shallbe in accordance with Specification E3109. Any warnings orextra care r

40、equired shall be clearly visible to the user.7. Keywords7.1 certification; glove; PPE; protective gloveAPPENDIX(Nonmandatory Information)X1. EXAMPLE TEST REPORTDate _Test Laboratory InformationLaboratory name, address, or through the ASTM website(www.astm.org). Permission rights to photocopy the sta

41、ndard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ X1.3 Documentation Inspection ResultsRequirements: Item is included in documentationItem verified to meet requirement(yes/no, if no explain)ObservationsDescription of type

42、s of threats that the glove is designed to protect against and the part ofthe glove that has the protection.Safety considerations, such as a notification to the user that the glove does not providepathogen protection.Recommendations and precautions regarding application of public safety agency marki

43、ngs,labels, adhesives, paints, or other items after purchase.Instructions and precautions regarding installation of attachments or modifications.Importance of proper fit and size.Instructions for proper use as intended by the supplier.Training recommendations for use of gloves; advice that pathogen

44、protection will be inaddition to this glove.Cleaning instructions and precautions.Recommended disinfection process.Recommended storage conditions and life expectancy under those conditions.Inspection details.Repair methods, where applicable.Warranty information, including time period and what the wa

45、rranty covers (for example,performance, workmanship, and materials).TABLE X1.4 Product Label Inspection ResultsRequirementsItem verified to meet requirement(yes/no, if no explain)ObservationsProduct label permanently attached to the inside of the gloveText font size at least116 inch in height (based

46、 on the lower case “o”) and easy to readName of supplier / RN (Registration Number) on product labelCountry of Origin on product labelDate of manufacture (that is, month and year) on product labelModel designation on product labelBatch or Lot # on product labelSize on product labelCertification mark

47、, if applicable, on product labelTABLE X1.5 Package Label Inspection ResultsRequirementsItem verified to meet requirement(yes/no, if no explain)ObservationsName and legal address of the supplier on package labelWarranty period on package labelType of protection and performance rating of the glove as specified in 6.1 of E3109 onpackage labelE3108 185