ASTM F543-07金属医用骨钉的标准规范说明和测试方法

金属螺钉的尺寸规格、检验方法等

Designation:F543–07

StandardSpeci cationandTestMethodsfor

MetallicMedicalBoneScrews1

Thisstandardisissuedunderthe xeddesignationF543;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.

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ThisstandardhasbeenapprovedforusebyagenciesoftheDepartmentofDefense.

1.Scope

1.1Thisspeci cationprovidesrequirementsformaterials, nishandmarking,careandhandling,andtheacceptabledimensionsandtolerancesformetallicbonescrewsthatareimplantedintobone.Thedimensionsandtolerancesinthisspeci cationareapplicableonlytometallicbonescrewsdescribedinthisspeci cation.

1.2Thisspeci cationprovidesperformanceconsiderationsandstandardtestmethodsformeasuringmechanicalpropertiesintorsionofmetallicbonescrewsthatareimplantedintobone.Thesetestmethodsmayalsobeapplicabletootherscrewsbesidesthosewhosedimensionsandtolerancesarespeci edhere.Thefollowingannexesareincluded:

1.2.1AnnexA1—TestMethodforDeterminingtheTor-sionalPropertiesofMetallicBoneScrews.

1.2.2AnnexA2—TestMethodforDrivingTorqueofMedi-calBoneScrews.

1.2.3AnnexA3—TestMethodforDeterminingtheAxialPulloutStrengthofMedicalBoneScrews.

1.2.4AnnexA4—TestMethodforDeterminingtheSelf-TappingPerformanceofSelf-TappingMedicalBoneScrews.1.2.5AnnexA5—Speci cationsforTypeHAandTypeHBMetallicBoneScrews.

1.2.6AnnexA6—Speci cationsforTypeHCandTypeHDMetallicBoneScrews.

1.2.7AnnexA7—Speci cationsforMetallicBoneScrewDriveConnections.

1.3Thisspeci cationisbased,inpart,uponISO5835,ISO6475,andISO9268.

1.4Unlessotherwiseindicated,thevaluesstatedinSIunitsaretoberegardedasstandard.Thevaluesinparenthesesaregivenforinformationonly.

1.5Thisstandardmayinvolvetheuseofhazardousmate-rials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandard

Thisspeci cationisunderthejurisdictionofASTMCommitteeF04onMedicalandSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommitteeOsteosynthesis.

CurrenteditionapprovedJune1,http://www.77cn.com.cnstpreviouseditionapprovedin2002asF543–02e1.

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toestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.

2.ReferencedDocuments2.1ASTMStandards:2

E4PracticesforForceVeri cationofTestingMachinesE6TerminologyRelatingtoMethodsofMechanicalTest-ing

E8TestMethodsforTensionTestingofMetallicMaterialsE122PracticeforCalculatingSampleSizetoEstimate,WithaSpeci edTolerableError,theAverageforaCharacteristicofaLotorProcess

F67Speci cationforUnalloyedTitanium,forSurgicalImplantApplications(UNSR50250,UNSR50400,UNSR50550,UNSR50700)

F86PracticeforSurfacePreparationandMarkingofMe-tallicSurgicalImplants

F116Speci cationforMedicalScrewdriverBits

F136Speci cationforWroughtTitanium-6Aluminum-4VanadiumELI(ExtraLowInterstitial)AlloyforSurgicalImplantApplications(UNSR56401)

F138Speci cationforWrought18Chromium-14Nickel-2.5MolybdenumStainlessSteelBarandWireforSurgicalImplants(UNSS31673)

F565PracticeforCareandHandlingofOrthopedicIm-plantsandInstruments

F620Speci cationforAlphaPlusBetaTitaniumAlloyForgingsforSurgicalImplants

F799Speci cationforCobalt-28Chromium-6MolybdenumAlloyForgingsforSurgicalImplants(UNSR31537,R31538,R31539)

F983PracticeforPermanentMarkingofOrthopaedicIm-plantComponents

F1295Speci cationforWroughtTitanium-6Aluminum-7NiobiumAlloyforSurgicalImplantApplications(UNSR56700)

ForreferencedASTMstandards,visittheASTMwebsite,http://www.77cn.com.cn,orcontactASTMCustomerServiceatservice@http://www.77cn.com.cn.ForAnnualBookofASTMStandardsvolumeinformation,refertothestandard’sDocumentSummarypageontheASTMwebsite.

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Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959,UnitedStates.

金属螺钉的尺寸规格、检验方法等

F1314Speci cationforWroughtNitrogenStrengthened22Chromium 13Nickel 5Manganese 2.5MolybdenumStainlessSteelAlloyBarandWireforSurgicalImplants(UNSS20910)

F1472Speci cationforWroughtTitanium-6Aluminum-4VanadiumAlloyforSurgicalImplantApplications(UNSR56400)

F1537Speci cationforWroughtCobalt-28Chromium-6MolybdenumAlloyforSurgicalImplants

F1586Speci cationforWroughtNitrogenStrengthened21Chromium—10Nickel—3Manganese—2.5MolybdenumStainlessSteelAlloyBarforSurgicalImplants(UNSS31675)

F1713Speci cationforWroughtTitanium-13Niobium-13ZirconiumAlloyforSurgicalImplantApplications(UNSR58130)

F1813Speci cationforWroughtTitanium 12Molybde-num 6Zirconium 2IronAlloyforSurgicalImplant(UNSR58120)

F1839Speci cationforRigidPolyurethaneFoamforUseasaStandardMaterialforTestingOrthopaedicDevicesandInstruments2.2ISOStandards:

5835ImplantsforSurgery—MetalBoneScrewswithHex-agonalDriverConnection,SphericalUnderSurfaceofHead,AsymmetricalThread—Dimensions3

6475ImplantsforSurgery—MetalBoneScrewswithAsymmetricalThreadandSphericalUnder-Surface—MechanicalRequirementsandTestMethods3

9268ImplantsforSurgery—MetalBoneScrewswithConi-calUnder-SurfaceofHead—Dimensions33.Terminology

3.1De nitions—Someofthetermsde nedinthissectionareshowninFig.1.

3.1.2breakingangle—angleofrotationwhenthescrewfailsintorsionasdemonstratedbyarapiddecreaseintheindicatedtorque.

3.1.3buttressthread—anasymmetricalthreadpro lechar-acterizedbyapressure ankwhichisnearlyperpendiculartothescrewaxis.

3.1.4cancellousscrew—ascrewdesignedprimarilytogainpurchaseintocancellousbone.CancellousscrewstypicallyhaveaHBthreadandmayormaynotbefullythreaded.3.1.5corticalscrew—ascrewdesignedprimarilytogainbiocorti …… 此处隐藏：49518字，全部文档内容请下载后查看。喜欢就下载吧 ……