ASTM_F_2848_-_17.pdf

Designation:F284817Standard Specification forMedical-Grade Ultra-High Molecular Weight PolyethyleneYarns1This standard is issued under the fixed designation F2848;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,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 specification covers ultra-high molecular weightpolyethylene(UHMWPE)yarns intended for use in medicaldevices or components of medical devices,such as sutures andligament fixations.This specification covers natural(non-colored)and pigmented(colored)yarns.1.2 This standard is intended to describe the requirementsand the procedures to be followed for testing UHMWPE yarnsas a component for medical devices prior to manufacturingprocesses of the medical device such as fabric formation,assembling and sterilization.This specification does not pur-port to address the requirements for the finished medicaldevices or the testing that is needed for medical devices that arefabricated from the components specified herein.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 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 safety and health practices and determine the applica-bility of regulatory limitations prior to use.1.5 This international standard was developed 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 Documents2.1 ASTM Standards:2D792 Test Methods for Density and Specific Gravity(Rela-tive Density)of Plastics by DisplacementD885/D885M Test Methods for Tire Cords,Tire CordFabrics,and Industrial Filament Yarns Made from Manu-factured Organic-Base FibersD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD1601 Test Method for Dilute Solution Viscosity of Ethyl-ene PolymersD1907/D1907M Test Method for Linear Density of Yarn(Yarn Number)by the Skein MethodD2256/D2256M Test Method for Tensile Properties of Yarnsby the Single-Strand MethodF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF756 Practice for Assessment of Hemolytic Properties ofMaterialsF2625 Test Method for Measurement of Enthalpy of Fusion,Percent Crystallinity,and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of DifferentialScanning Calorimetry2.2 ISO Standards:3ISO 1628-3 PlasticsDetermination of the Viscosity ofPolymersinDiluteSolutionUsingCapillaryViscometersPart 3:Polyethylenes and PolypropylenesISO 2062 TextilesYarns from PackagesDeterminationof Single-end Breaking Force and Elongation at BreakISO 10993-1 Biological Evaluation of Medical Devices Part1 Evaluation and testing within a risk managementprocesssISO 10993-4 Biological Evaluation of Medical Devices Part4 Selection of tests for interactions with bloodISO 10993-5 Biological Evaluation of Medical Devices Part5 Tests for in vitro cytotoxicityISO 10993-10 Biological Evaluation of Medical Devices Part 10:Tests for irritation and skin sensitizationISO 10993-17 Biological Evaluation of Medical DevicesPart 17 Establishment for allowable limits for leachablesubstances1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved May 1,2017.Published July 2017.Originally approvedin 2010.Last previous edition approved in 2016 as F284816.DOI:10.1520/F284817.2For 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 ASTM website.3Available from International Organization for Standardization(ISO),1,ch.dela Voie-Creuse,Case postale 56,CH-1211,Geneva 20,Switzerland,http:/www.iso.ch.Copyright ASTM International,100 Barr Harbor 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 Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 ISO 8 Biological Evaluation of Medical Devices Part 18 Chemical characterization of materialsISO 13485 Medical Devices Quality Management Sys-tems Requirements for regulatory purposesISO 14971 Medical Devices Application of risk m