Designation:F603−12StandardSpecificationforHigh-PurityDenseAluminumOxideforMedicalApplication1ThisstandardisissuedunderthefixeddesignationF603;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversthematerialrequirementsforhigh-purity,densealuminumoxideforload-bearingsurgicalimplantapplications.1.2Thisspecificationdoesnotcoverfinishedparts(forexample,femoralheads,acetabularinserts,dentalimplantsandthelike).Itisintendedasaqualificationofthematerialasdeliveredtothepartsmanufacturer.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.2.ReferencedDocuments2.1ASTMStandards:2C373TestMethodforWaterAbsorption,BulkDensity,ApparentPorosity,andApparentSpecificGravityofFiredWhitewareProductsC1161TestMethodforFlexuralStrengthofAdvancedCeramicsatAmbientTemperatureC1198TestMethodforDynamicYoung’sModulus,ShearModulus,andPoisson’sRatioforAdvancedCeramicsbySonicResonanceC1239PracticeforReportingUniaxialStrengthDataandEstimatingWeibullDistributionParametersforAdvancedCeramicsC1259TestMethodforDynamicYoung’sModulus,ShearModulus,andPoisson’sRatioforAdvancedCeramicsbyImpulseExcitationofVibrationC1327TestMethodforVickersIndentationHardnessofAdvancedCeramicsE112TestMethodsforDeterminingAverageGrainSizeF981PracticeforAssessmentofCompatibilityofBiomate-rialsforSurgicalImplantswithRespecttoEffectofMaterialsonMuscleandBone2.2AmericanSocietyforQualityControlStandard:3ASQC1SpecificationofGeneralRequirementsforaQual-ityProgram2.3ISOStandard:4ISO6474ImplantsforSurgery—CeramicMaterialsBasedonAlumina3.ChemicalRequirements3.1ThechemicalcompositionshallbeasfollowsinTable1,(measuredbyICP-AES,XRF,ormassspectrocopy):4.PhysicalRequirements4.1Theminimumbulkdensityshallbe(3.9460.01)g/cm3asdeterminedbyTestMethodC373a...
