Designation:F2381−10StandardTestMethodforEvaluatingTrans-VinyleneYieldinIrradiatedUltra-HighMolecularWeightPolyethyleneFabricatedFormsIntendedforSurgicalImplantsbyInfraredSpectroscopy1ThisstandardisissuedunderthefixeddesignationF2381;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethoddescribesthemeasurementofthenumberoftrans-vinylenegroupsinultra-highmolecularweightpolyethylene(UHMWPE)intendedforuseinmedicalimplants.Thematerialisanalyzedbyinfraredspectroscopy.1.2ThistestmethodisbasedonGuideF2102.1.3Theapplicabilityoftheinfraredmethodhasbeendemonstratedinotherliteraturereports.Thisparticularmethod,usingtheintensity(area)oftheC-Habsorptioncenteredat1370cm-1tonormalizeforthesample’sthickness,willbevalidatedbyanInterlaboratoryStudy(ILS)conductedaccordingtoPracticeE691.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E691PracticeforConductinganInterlaboratoryStudytoDeterminethePrecisionofaTestMethodE1421PracticeforDescribingandMeasuringPerformanceofFourierTransformMid-Infrared(FT-MIR)Spectrom-eters:LevelZeroandLevelOneTestsF2102GuideforEvaluatingtheExtentofOxidationinPolyethyleneFabricatedFormsIntendedforSurgicalImplants3.Terminology3.1Definitions:3.1.1trans-vinyleneindex(TVI)—atrans-vinyleneindexisdefinedastheratiooftheareaoftheabsorptionpeakcenterednear965cm-1totheareaoftheabsorptionpeakcenterednear1370cm-1.3.1.2depthlocator(DL)—ameasurementofthedistancefromthearticularsurface,orsurfaceofinterest,thataspect...
