Designation:F2384−10(Reapproved2016)StandardSpecificationforWroughtZirconium-2.5NiobiumAlloyforSurgicalImplantApplications(UNSR60901)1ThisstandardisissuedunderthefixeddesignationF2384;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversthechemical,mechanical,andmetallurgicalrequirementsforwroughtzirconium-2.5niobiumalloytobeusedinthemanufactureofsurgicalimplants(1).21.2ThevaluesstatedineitherSIunitsorinch-poundunitsaretoberegardedseparatelyasstandard.Thevaluesstatedineachsystemmaynotbeexactequivalents;therefore,eachsystemshallbeusedindependentlyoftheother.Combiningvaluesfromthetwosystemsmayresultinnon-conformancewiththestandard.2.ReferencedDocuments2.1ASTMStandards:3B550/B550MSpecificationforZirconiumandZirconiumAlloyBarandWireE8/E8MTestMethodsforTensionTestingofMetallicMa-terialsE29PracticeforUsingSignificantDigitsinTestDatatoDetermineConformancewithSpecificationsE112TestMethodsforDeterminingAverageGrainSizeE1552TestMethodforDeterminingHafniuminZirconiumandZirconiumAlloysByDirectCurrentPlasma—AtomicEmissionSpectrometryE1941TestMethodforDeterminationofCarboninRefrac-toryandReactiveMetalsandTheirAlloysbyCombustionAnalysisE2626GuideforSpectrometricAnalysisofReactiveandRefractoryMetalsF67SpecificationforUnalloyedTitanium,forSurgicalIm-plantApplications(UNSR50250,UNSR50400,UNSR50550,UNSR50700)F748PracticeforSelectingGenericBiologicalTestMethodsforMaterialsandDevicesSI10AmericanNationalStandardforUseoftheInterna-tionalSystemofUnits(SI):TheModernMetricSystem2.2ISOStandard:4ISO6892MetallicMaterialsTensileTestingatAmbientTemperatureISO9001QualityManagementSystems—Requirements3.Terminology3.1DefinitionsofTermsSpecifictoThisStandard:3.1.1annealed,adj—materialthatexhibitsarecrystalizedgrainstructure.3.1.2lot,n—thetotalnumberofmillprodu...
