Designation:F2393−12StandardSpecificationforHigh-PurityDenseMagnesiaPartiallyStabilizedZirconia(Mg-PSZ)forSurgicalImplantApplications1ThisstandardisissuedunderthefixeddesignationF2393;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversmaterialrequirementsforhigh-purity,densezirconiumoxidepartiallystabilizedbymagnesiumoxide(magnesiapartiallystabilizedzirconia(Mg-PSZ))forsurgicalimplantapplications.1.2ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatoryrequirementspriortouse.2.ReferencedDocuments2.1ASTMStandards:2C373TestMethodforWaterAbsorption,BulkDensity,ApparentPorosity,andApparentSpecificGravityofFiredWhitewareProductsC1161TestMethodforFlexuralStrengthofAdvancedCeramicsatAmbientTemperatureC1198TestMethodforDynamicYoung’sModulus,ShearModulus,andPoisson’sRatioforAdvancedCeramicsbySonicResonanceC1239PracticeforReportingUniaxialStrengthDataandEstimatingWeibullDistributionParametersforAdvancedCeramicsC1259TestMethodforDynamicYoung’sModulus,ShearModulus,andPoisson’sRatioforAdvancedCeramicsbyImpulseExcitationofVibrationC1327TestMethodforVickersIndentationHardnessofAdvancedCeramicsE112TestMethodsforDeterminingAverageGrainSize2.2AmericanSocietyforQualityStandard(ASQ):C1SpecificationofGeneralRequirementsforaQualityProgram32.3ISOStandard:ISO18754FineCeramics(AdvancedCeramics,AdvancedTechnicalCeramics)—DeterminationofDensityandAp-parentPorosity43.ChemicalRequirements3.1Thechemicalcompositionshallbeasfollows,measuredbyICP-ES,XRF,ormassspectroscopy:OxidesWeightpercentZr...
