钛金属材料电子档医用F136标准

Designation:F67–06StandardSpecificationforUnalloyedTitanium,forSurgicalImplantApplications(UNSR50250,UNSR50400,UNSR50550,UNSR50700)1ThisstandardisissuedunderthefixeddesignationF67;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope*1.1Thisspecificationcoversthechemical,mechanical,andmetallurgicalrequirementsforfourgradesofunalloyedtita-niumstrip,sheet,plate,bar,billet,forging,andwireusedforthemanufactureofsurgicalimplants.1.2Thevaluesstatedininch-poundunitsaretoberegardedasthestandard.TheSIequivalentsinparenthesesareforinformationonly.2.ReferencedDocuments2.1ASTMStandards:2B265SpecificationforTitaniumandTitaniumAlloyStrip,Sheet,andPlateB348SpecificationforTitaniumandTitaniumAlloyBarsandBilletsB381SpecificationforTitaniumandTitaniumAlloyForg-ingsE8TestMethodsforTensionTestingofMetallicMaterialsE29PracticeforUsingSignificantDigitsinTestDatatoDetermineConformancewithSpecificationsE290TestMethodsforBendTestingofMaterialforDuctilityE1409TestMethodforDeterminationofOxygenandNitrogeninTitaniumandTitaniumAlloysbytheInertGasFusionTechniqueE1447TestMethodforDeterminationofHydrogeninTitaniumandTitaniumAlloysbytheInertGasFusionThermalConductivity/InfraredDetectionMethodE2371TestMethodforAnalysisofTitaniumandTitaniumAlloysbyAtomicEmissionPlasmaSpectrometryF981PracticeforAssessmentofCompatibilityofBioma-terialsforSurgicalImplantswithRespecttoEffectofMaterialsonMuscleandBone2.2AerospaceMaterialSpecification:AMS2249ChemicalCheckAnalysisLimits,TitaniumandTitaniumAlloys32.3ISOStandards:ISO5832-2ImplantsforSurgery—MetallicMaterials—UnalloyedTitanium4ISO6892MetallicMaterials—TensileTestingatAmbientTemperature4ISO9001QualityManagementSystems42.4AmericanSocietyforQuality(ASQ)Standard:C1SpecificationsofGeneralRequirementsforaQualityProgram43.Terminology3.1DefinitionofTermSpecifictoThisStandard:3.1.1lot,n—thetotalnumberofmillproductsproducedfromthesamemeltheatunderthesameconditionsatessen-tiallythesametime.4.ProductClassification4.1ProductclassificationsareconsistentwithSpecificationsB265,B348,andB381.4.1.1Strip—Anyproduct0.1875in.(4.76mm)andunderinthicknessandlessthan24in.(610mm)inwidth.4.1.2Sheet—Anyproduct0.1875in.(4.76mm)andunderinthicknessand24in.(610mm)ormoreinwidth.4.1.3Plate—Anyproduct0.1875in.(4.76mm)thickandoverand10in.(254mm)wideandover,withwidthsgreaterthanfivetimesthickness.Plateupto4in.(101.60mm),thickinclusiveiscoveredbythisspecification.4.1.4Bar—Rounds,flats,orothershapesfrom0.1875in.(4.76mm)to4in.(101.60mm)indiameterorthickness.(Othersizesandshapesbyspecialorder.)4.1.5Billet—Asolidsemi-finishedsectionhotrolledorforgedfromaningot,withacrosssectionalareagreaterthan16in.2(10322mm2)whosewidthislessthan5timesitsthickness.4.1.6Forging—Anyproductofworkonmetalformedtoadesiredshapebyimpactorpressureinhammers,forgingmachines,upsetpresses,orrelatedformingequipment.1ThisspecificationisunderthejurisdictionofASTMCommitteeF04onMedicalandSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommitteeF04.12onMetallurgicalMaterials.CurrenteditionapprovedJune1,2006.PublishedJune2006.Originallyapprovedin1966.Lastpreviouseditionapprovedin2000asF67–00.2ForreferencedASTMstandards,visittheASTMwebsite,@astm.org.ForAnnualBookofASTMStandardsvolumeinformation,refertothestandard’sDocumentSummarypageontheASTMwebsite.3AvailablefromSocietyofAutomotiveEngineers(SAE),400CommonwealthDr.,Warrendale,PA15096-0001.4AvailablefromAmericanSocietyforQuality(ASQ),600N.PlankintonAve.,Milwaukee,WI53203.1*ASummaryofChangessectionappearsattheendofthisstandard.Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959,UnitedStates.LicensedbyWEXtoAMERICANUNIVERSITYOFBEIRUT.Downloaded:12/13/200712:38:11AMsingle-userlicenseonly,copyingandnetworkingprohibited./4.1.7Wire—Rounds,flatsorothershapeslessthan0.1875in.(4.76mm)indiameterorthickness.4.1.8Other—Otherformsandshapes,includingtubing,maybeprovidedbyagreementbetweenpurchaserandsup-plier.5.OrderingInformation5.1Inquiriesandordersformaterialunderthisspecificationshallincludethefollowinginformation:5.1.1Quantity(weightornumberofpieces),5.1.2Grade(1,2,3,or4),5.1.3ASTMdesignation,5.1.4Form(sheet,strip,plate,bar,billet,forging,wire,orotherforms),5.1.5Condition(see6.1),5.1.6Mechanicalproperties(ifapplicable,forspecialcon-ditions),5.1.7Finish(see6.2),5.1.8Applicabledimensionsandtolerancesincludingsize,thickness,width,andlength(exact,random,multiples)ordrawingnumber,5.1.9Specialtests,and5.1.10Otherrequirements.6.Manufacture6.1Condition—Materialshallbefurnishedinthehot-worked,cold-worked,forged,annealed,orstress-relievedcon-dition.6.2Finish—Unalloyedtitaniummaterialshallbefreeofinjuriousexternalandinternalimperfectionsofanaturethatwillinterferewiththepurposeforwhichitisintended.Themillproductmaybefurnishedasdescaledorpickled,abrasiveblast