Designation:F2102−17StandardGuideforEvaluatingtheExtentofOxidationinPolyethyleneFabricatedFormsIntendedforSurgicalImplants1ThisstandardisissuedunderthefixeddesignationF2102;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1ThisguidecoversamethodforthemeasurementoftherelativeextentofoxidationpresentinHDPEhomopolymersandultra-high-molecular-weightpolyethylene(UHMWPE)in-tendedforuseinmedicalimplants.Thematerialisanalyzedbyinfraredspectroscopy.Theintensity(area)ofthecarbonylabsorptions(>C=O)centerednear1720cm-1isrelatedtotheamountofchemicallyboundoxygenpresentinthematerial.Otherformsofchemicallyboundoxygen(C-O-C,C-O-O-C,C-O-H,andsoforth)arenotcapturedbythisguide.1.2AlthoughthisguidemaygivetheinvestigatorameanstocomparetherelativeextentofcarbonyloxidationpresentinvariousUHMWPEsamples,itisrecognizedthatotherformsofchemicallyboundoxygenmaybeimportantcontributorstothesematerials’characteristics.1.3Theapplicabilityoftheinfraredmethodhasbeendemonstratedbymanyliteraturereports.Thisparticularmethod,usingtheintensity(area)oftheC-Habsorptioncenterednear1370cm-1tonormalizeforthesample’sthickness,hasbeenvalidatedbyanInterlaboratoryStudy(ILS)conductedaccordingtoPracticeE691.1.4Thefollowingprecautionarycaveatpertainsonlytothetestmethodportion,Section5,ofthisspecification:Thisstandardmayinvolvehazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatoryrequirementspriortouse.1.5Thisinternationalstandardwasdevelopedinaccor-dancewithinternationallyrecognizedprinciplesonstandard-izationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandR...
