ASTM_F_2565_-_13.pdf

Designation:F256513Standard Guide forExtensively Irradiation-Crosslinked Ultra-High MolecularWeight Polyethylene Fabricated Forms for Surgical ImplantApplications1This standard is issued under the fixed designation F2565;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 guide covers extensively crosslinked ultra-highmolecular weight polyethylene(UHMWPE)materials(fabri-cated forms)that are produced starting with virgin resinpowders and consolidated forms meeting all the requirementsof Test Method F648.1.2 This guide does not cover fabricated forms of ultra-highmolecular weight polyethylene which have received only gasplasma,ethylene oxide,or less than 40 kGy ionizing radiationtreatments,that is,materials treated only by historical steril-ization methods.1.3 This guide pertains only to UHMWPE materials exten-sively crosslinked by gamma and electron beam sources ofionizing radiation.1.4 The specific relationships between these mechanicalproperties and the in vivo performance of a fabricated formhave not been determined.While trends are apparent,specificproperty-polymer structure and polymer-design relationshipsare not well understood.These mechanical tests are frequentlyused to evaluate the reproducibility of a fabrication procedureand are applicable for comparative studies of different materi-als.1.5 The following precautionary caveat pertains only to thetest method portion,Section 5,of this guide.This standarddoes not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the user of thisstandard to establish appropriate safety and health practicesand determine the applicability of regulatory limitations priorto use.2.Referenced Documents2.1 ASTM Standards:2D638 Test Method for Tensile Properties of PlasticsD695 Test Method for Compressive Properties of RigidPlasticsD1898 Practice for Sampling of Plastics(Withdrawn 1998)3D2765 Test Methods for Determination of Gel Content andSwell Ratio of Crosslinked Ethylene PlasticsE647 Test Method for Measurement of Fatigue CrackGrowth RatesF619 Practice for Extraction of Medical PlasticsF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF749 Practice for Evaluating Material Extracts by Intracuta-neous Injection in the RabbitF756 Practice for Assessment of Hemolytic Properties ofMaterialsF763 Practice for Short-Term Screening of Implant Materi-alsF813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF895 Test Method forAgar Diffusion Cell Culture Screeningfor CytotoxicityF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF2003 Practice for Accelerated Aging of Ultra-High Mo-lecular Weight Polyethylene after Gamma Irradiation inAir1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved July 15,2013.Published August 2013.Originallyapproved in 2006.Last previous edition approved in 2006 as F2565-06.DOI:10.1520/F2565-13.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 F2102 Guide for Evaluating the Extent of Oxidation inUltra-High-Molecular-Weight Polyethylene FabricatedForms Intended for Surgical ImplantsF2183 Test Method for Small Punch Testing of Ultra-HighMolecular Weight Polyethylene Used in Surgical ImplantsF2214 Test Method forIn Situ Determination of NetworkParameters of Crosslinked Ultra High Molecular WeightPolyethylene(UHMWPE)F2381 Test Method for Evaluating Trans-Vinylene Yield inIrradiated Ultra-High Molecular Weight PolyethyleneFabricated Forms Intended for Surgical Implants by In-frared SpectroscopyF2625 Test Method for Measurement of Enthalpy of Fusion,Percent Crystallinity,and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of DifferentialScanning CalorimetryF2759 Guide for Assessment of the Ultra High MolecularWeight Polyethylene(UHMWPE)Used in Orthopedic andSpinal Devices2.2 ISO Standards:4ISO 10993 Biological Evaluation of Medical Devices,Parts1-12ISO 527 PlasticsDetermination of Tensile PropertiesPart 1:General Principles3.Terminology3.1 Definitions