Designation:F2695−12StandardSpecificationforUltra-HighMolecularWeightPolyethylenePowderBlendedWithAlpha-Tocopherol(VitaminE)andFabricatedFormsforSurgicalImplantApplications1ThisstandardisissuedunderthefixeddesignationF2695;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversultra-highmolecularweightpolyethylene(UHMWPE)powderblendedwithalpha-tocopherol(vitaminE)intendedforuseinsurgicalimplants.1.2Therequirementsofthisspecificationapplytoalpha-tocopherol-containingUHMWPEintwoforms.Oneisvirginpolymerpowderblendedwithalpha-tocopherolpriortocon-solidation(Section4).Thesecondisanyformfabricatedfromthisblended,alpha-tocopherol-containingpowderfromwhichafinishedproductissubsequentlyproduced(Section5).Thisspecificationdoesnotapplytofinishedorsemi-finishedproductsthataredopedwithvitaminEafterconsolidation.1.3Asidefromblendingwithalpha-tocopherol,theprovi-sionsofSpecificationsF648andD4020apply.Specialrequire-mentsdetailedinthisspecificationareaddedtodescribepowderscontainingalpha-tocopherolthatwillbeusedinsurgicalimplants.Thisspecificationaddressesmaterialchar-acteristicsanddoesnotapplytothepackagedandsterilizedfinishedimplant.ThisspecificationalsodoesnotapplytoUHMWPEmaterialsextensivelycrosslinkedbygammaandelectronbeamsourcesofionizingradiation.1.4Thefollowingprecautionarycaveatpertainsonlytothefabricatedformsportion,Section5,ofthisspecification.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimita-tionspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D648TestMethodforDeflectionTemperatureofPlasticsUnderFlexuralLoadintheEdgewisePositionD790TestMethodsforFlexuralPropertieso...
