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Designation:F136–02aStandardSpecificationforWroughtTitanium-6Aluminum-4VanadiumELI(ExtraLowInterstitial)AlloyforSurgicalImplantApplications(UNSR56401)1ThisstandardisissuedunderthefixeddesignationF136;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope*1.1Thisspecificationcoversthechemical,mechanical,andmetallurgicalrequirementsforwroughtannealedtitanium-6aluminum-4vanadiumELI(extralowinterstitial)alloy(R56401)tobeusedinthemanufactureofsurgicalimplants.1.2Thevaluesstatedininch-poundunitsaretoberegardedasthestandard.TheSIequivalentsinparenthesesareprovidedforinformationonly.2.ReferencedDocuments2.1ASTMStandards:E8TestMethodsofTensionTestingofMetallicMaterials2E120TestMethodsforChemicalAnalysisofTitaniumandTitaniumAlloys3E290TestMethodforBendTestingofMaterialsforDuctility3E527PracticeforNumberingMetalsandAlloys(UNS)4E1409TestMethodforDeterminationofOxygeninTita-niumandTitaniumAlloysbytheInertGasFusionTech-nique5E1447TestMethodforDeterminationofHydrogeninTitaniumandTitaniumAlloysbytheInertGasFusionThermalConductivityMethod3F981PracticeforAssessmentofCompatibilityofBioma-terialsforSurgicalImplantswithRespecttoEffectofMaterialsonMuscleandBone62.2ASQStandard:ASQC1SpecificationsofGeneralRequirementsforaQualityControlProgram72.3AerospaceMaterialSpecifications:8AMS2249ChemicalCheckAnalysisLimits,TitaniumandTitaniumAlloysAMS4930TitaniumAlloyBars,Forgings,andRings6AL-4VExtraLowInterstitialAnnealed2.4SocietyofAutomotiveEngineersStandard:SAEJ1086PracticeforNumberingMetalsandAlloys(UNS)93.Terminology3.1DefinitionsofTermsSpecifictoThisStandard:3.1.1lot,n—thetotalnumberofmillproductsproducedfromoneheatunderthesameconditionsatessentiallythesametime.4.ProductClassification4.1Strip—Anyproductunder0.1875in.(4.75mm)inthicknessandunder24in.(610mm)wide.4.2Sheet—Anyproductunder0.1875in.(4.75mm)inthicknessand24in.(610mm)ormoreinwidth.4.3Plate—Anyproduct0.1875in.(4.75mm)thickandoverand10in.(254mm)wideandover,withwidthsgreaterthanfivetimesthickness.Plateupto4.00in.(101.60mm),thickinclusiveiscoveredbythisspecification.4.4Bar—Roundbarsandflatsfrom0.1875in.(4.75mm)to4.00in.(101.60mm)indiameterorthickness(othersizesandshapesbyspecialorder).4.5ForgingBar—Barasdescribedin4.4,usedforproduc-tionofforgings,maybefurnishedinthehotrolledcondition.4.6Wire—Roundslessthan0.1875in.(4.75mm)indiam-eter.5.OrderingInformation5.1Includewithinquiriesandordersformaterialunderthisspecificationthefollowinginformation:5.1.1Quantity,5.1.2ASTMdesignationanddateofissue,1ThisspecificationisunderthejurisdictionofASTMCommitteeF04onMedicalandSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommitteeF04.12onMetallurgicalMaterials.CurrenteditionapprovedNov.10,2002.PublishedDecember2002.Originallypublishedin1984.Lastpreviouseditionapprovedin2002asF136–02.2AnnualBookofASTMStandards,Vol03.01.3AnnualBookofASTMStandards,Vol03.05.4AnnualBookofASTMStandards,Vol01.01.5AnnualBookofASTMStandards,Vol03.06.6AnnualBookofASTMStandards,Vol13.01.7AvailablefromAmericanSocietyforQuality,600N.PlankintonAve.,Milwaukee,WI53203.8AvailablefromSocietyofAutomotiveEngineers(SAE),400CommonwealthDr.,Warrendale,PA15096-0001.9NewdesignationestablishedinaccordancewithE527andSAEJ1086.1*ASummaryofChangessectionappearsattheendofthisstandard.Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959,UnitedStates.5.1.3Form(sheet,strip,plate,bar,orwire),5.1.4Condition(See6.3),5.1.5Mechanicalproperties(ifapplicable,forspecialcon-ditions),5.1.6Finish(See6.2),5.1.7Applicabledimensionsincludingsize,thickness,width,ordrawingnumber,5.1.8Specialtests,ifany,and5.1.9Otherrequirements.6.MaterialsandManufacture6.1Thevarioustitaniummillproductscoveredinthisspecificationnormallyareformedwiththeconventionalforg-ingandrollingequipmentfoundinprimaryferrousandnonferrousplants.Thealloyisusuallymultiplemeltedinarcfurnaces(includingfurnacessuchasplasmaarcandelectronbeam)ofatypeconventionallyusedforreactivemetals.6.2Finish—Themillproductmaybefurnishedtotheimplantmanufacturerasmechanicallydescaledorpickled,sandblasted,chemicallymilled,ground,machined,peeled,polished,combinationsoftheseoperations,orasspecifiedbythepurchaser.6.3Condition—Materialshallbefurnishedintheannealedorcold-workedcondition.7.ChemicalRequirements7.1Theheatanalysisshallconformtothechemicalcom-positionofTable1.Ingotanalysismaybeusedforreportingallchemicalrequirements,excepthydrogen.Samplesforhydro-genshallbetakenfromthefinishedmillproduct.SuppliershallnotshipmaterialwithchemistryoutsidetherequirementsspecifiedinTable1.7.1.1RequirementsforthemajorandminorelementalconstituentsarelistedinTable1.Alsolistedareimportantresidualelements.AnalysisforelementsnotlistedinTable1isnotrequiredtoverifycompliancewiththisspecification.7.2ProductAnalysis—Productanalysistolerancesdonotbroadenthespecifiedheatanalysisrequirementsbutcovervariationsbetwe
本文标题:钛金属医用材料电子档资料
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