Designation:F1635−11StandardTestMethodforinvitroDegradationTestingofHydrolyticallyDegradablePolymerResinsandFabricatedFormsforSurgicalImplants1ThisstandardisissuedunderthefixeddesignationF1635;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodcoversinvitrodegradationofhydro-lyticallydegradablepolymers(HDP)intendedforuseinsurgicalimplants.1.2TherequirementsofthistestmethodapplytoHDPsinvariousforms:1.2.1Virginpolymerresins,or1.2.2Anyformfabricatedfromvirginpolymersuchasasemi-finishedcomponentofafinishedproduct,afinishedproduct,whichmayincludepackagedandsterilizedimplants,oraspeciallyfabricatedtestspecimen.1.3Thistestmethodprovidesguidanceformechanicalloadingorfluidflow,orboth,whenrelevanttothedevicebeingevaluated.Thespecificsofloadingtype,magnitude,andfrequencyforagivenapplicationarebeyondthescopeofthistestmethod.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D638TestMethodforTensilePropertiesofPlasticsD671TestMethodforFlexuralFatigueofPlasticsbyConstant-Amplitude-of-Force(Withdrawn2002)3D695TestMethodforCompressivePropertiesofRigidPlasticsD747TestMethodforApparentBendingModulusofPlas-ticsbyMeansofaCantileverBeamD790TestMethodsforFlexuralPropertiesofUnreinforcedandReinforcedPlasticsandElectricalInsulatingMateri-alsD882TestMethodforTensilePropertiesofThinPlasticSheetingD1708TestMethodforTensilePropertiesofPlasticsbyUseofMicrotensileSpecimensD1822TestMethodforTensile-ImpactEnergytoBreakPlasticsandElectricalI...
