Designation:F2759−11StandardGuideforAssessmentoftheUltraHighMolecularWeightPolyethylene(UHMWPE)UsedinOrthopedicandSpinalDevices1ThisstandardisissuedunderthefixeddesignationF2759;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidecoversgeneralguidelinesforthephysical,chemical,biocompatibility,mechanical,andpreclinicalassess-mentsofultra-highmolecularweightpolyethylene(UHM-WPE)inimplantableorthopedicandspinaldevicesintendedtoreplaceamusculoskeletaljoint.TheUHMWPEcomponentsmayincludeknee,hip,shoulder,elbow,ankle,totaldiscreplacement,toe,finger,andwristjointimplantdevices.ThisguidedoesnotcoverUHMWPEinfiberortapeforms.1.2ThisguideincludesadescriptionandrationaleofassessmentsforthevariousUHMWPEtypesandprocessingconditions.Assessmenttestingbasedonphysical,chemical,biocompatibility,mechanical,andpreclinicalanalysesarebrieflydescribedandreferenced.Theusershouldrefertospecifictestmethodsforadditionaldetails.1.3Thisguidedoesnotattempttodefinealloftheassess-mentmethodsassociatedwithUHMWPEcomponentsinorthopedicandspinaldevices.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D256TestMethodsforDeterminingtheIzodPendulumImpactResistanceofPlasticsD638TestMethodforTensilePropertiesofPlasticsD695TestMethodforCompressivePropertiesofRigidPlasticsD883TerminologyRelatingtoPlasticsD2765TestMethodsforDeterminationofGelContentandSwellRatioofCrosslinkedEthylenePlasticsD4020SpecificationforUltra-High-Molecular-WeightPoly-ethyleneMoldingan...
