Designation:F2565−13StandardGuideforExtensivelyIrradiation-CrosslinkedUltra-HighMolecularWeightPolyethyleneFabricatedFormsforSurgicalImplantApplications1ThisstandardisissuedunderthefixeddesignationF2565;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidecoversextensivelycrosslinkedultra-highmolecularweightpolyethylene(UHMWPE)materials(fabri-catedforms)thatareproducedstartingwithvirginresinpowdersandconsolidatedformsmeetingalltherequirementsofTestMethodF648.1.2Thisguidedoesnotcoverfabricatedformsofultra-highmolecularweightpolyethylenewhichhavereceivedonlygasplasma,ethyleneoxide,orlessthan40kGyionizingradiationtreatments,thatis,materialstreatedonlybyhistoricalsteril-izationmethods.1.3ThisguidepertainsonlytoUHMWPEmaterialsexten-sivelycrosslinkedbygammaandelectronbeamsourcesofionizingradiation.1.4Thespecificrelationshipsbetweenthesemechanicalpropertiesandtheinvivoperformanceofafabricatedformhavenotbeendetermined.Whiletrendsareapparent,specificproperty-polymerstructureandpolymer-designrelationshipsarenotwellunderstood.Thesemechanicaltestsarefrequentlyusedtoevaluatethereproducibilityofafabricationprocedureandareapplicableforcomparativestudiesofdifferentmateri-als.1.5Thefollowingprecautionarycaveatpertainsonlytothetestmethodportion,Section5,ofthisguide.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D638TestMethodforTensilePropertiesofPlasticsD695TestMethodforCompressivePropertiesofRigidPlasticsD1898PracticeforSamplingofPlastics(Withdrawn1998)3D2765TestMethodsforDeterminationofGelContentandSwellRatioofCrosslinkedEthylenePlas...
