Designation:F3160−16StandardGuideforMetallurgicalCharacterizationofAbsorbableMetallicMaterialsforMedicalImplants1ThisstandardisissuedunderthefixeddesignationF3160;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidancedocumentprovidesmetallurgicalcharac-terizationinformationthatmaybebeneficialintheevaluationofabsorbablemetallicmaterialsintendedformedicalimplantapplications.Thisguideisprimarilyintendedforabsorbablemetallicmaterialsthatundergofurtherprocessingintoafabricatedfinaldevice.Therefore,thisstandarddoesnotrequireassessmentsthataremoreappropriatelyconductedonthefinaldevice,suchasbiologicalevaluation.However,afewrelevantstandardsforfinishedimplantdevicesareincludedforinformationpurposes.1.2Thepurposeofthisguideistoidentifyappropriatetestmethodsandrelevantmedicalproductstandardsthatcanbeusedtodevelopfuturestandardsfornewormodifiedabsorb-ablemetallicmaterials.1.3Thisguideisnotintendedtocoverothermajorclassesofabsorbablematerialssuchaspolymers,ceramics,composites,andtissue-engineeredmaterials.1.4Thisstandardguideisfocusedonthechemical,physical,microstructural,andmechanicalpropertiesplusin-spectionguidelinesformetallicmaterialsthatareusedformedicalimplantsdesignedtobeabsorbedinthebodyoveraperiodoftime.Thisguidefocusesonmaterialcharacteriza-tionsanddoesnotaddressdevicespecificmechanicaltestingthatmaybenecessarytodeterminesafetyandfunctionalityoftheimplant.1.5Compliancewithmaterialsspecificationsdevelopedinaccordancewiththisstandardmaynotnecessarilyresultinamaterialsuitableforitsintendedpurpose.Additionaltestingspecifictotheintendedusemayberequired.1.6Sincesurfacemodificationsofmedicalimplantsaregenerallyappliedinthelatterstagesofmanufacturing,thisstandardguidedoesnotcoverthecharacterizationofeitherabsorbableornon-absorbablesurfacecoatingsthat...
