Designation:F1408−97(Reapproved2013)StandardPracticeforSubcutaneousScreeningTestforImplantMaterials1ThisstandardisissuedunderthefixeddesignationF1408;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticecoversashort-termtestingmethodtoscreenthesubcutaneoustissuereactiontometallicorotherimplantcandidatematerialsinsmalllaboratoryanimals.Thematerialmaybedenseorporous.Thetissuereactionswillbeevaluatedincomparisontothoseevokedbycontrolmaterialsthatareacceptedasclinicalimplantmaterials.1.2Thispractice,alongwithotherappropriatebiologicaltests(includingotherASTMtestmethods),maybeusedtoassessthebiocompatibilityofcandidatematerialsforuseinthefabricationofdevicesforclinicalapplication.Itmaybealsoappliedtoevaluatetheeffectofspecialsurfacetexturesandpreparationsofknownmaterials.1.3Thisexperimentalprotocolisnotdesignedtoprovideacomprehensiveassessmentofthesystemictoxicity,carcinogenicity,teratogenicity,ormutagenicityofthematerial.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F67SpecificationforUnalloyedTitanium,forSurgicalIm-plantApplications(UNSR50250,UNSR50400,UNSR50550,UNSR50700)F75SpecificationforCobalt-28Chromium-6MolybdenumAlloyCastingsandCastingAlloyforSurgicalImplants(UNSR30075)F86PracticeforSurfacePreparationandMarkingofMetal-licSurgicalImplantsF136SpecificationforWroughtTitanium-6Aluminum-4VanadiumELI(ExtraLowInterstitial)AlloyforSurgicalImplantApplications(UNSR56401)F138SpecificationforWrought18Chromium-14Nicke...
