ASTM-F116-00(2004)-医疗用螺丝刀

Designation:F116–00(Reapproved2004)StandardSpecificationforMedicalScrewdriverBits1ThisstandardisissuedunderthefixeddesignationF116;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverstheacceptabledimensionsandtolerancesforbitsofscrewdriverstoinsertandremovemetalscrewsusedassurgicalimplants.1.2Thisspecificationisbased,inpart,uponISO8319-1andISO8319-2.1.3Thescrewdriverswiththebitsdescribedinthisspeci-ficationaresuitableforusewithscrewsdescribedinSpecifi-cationF543,ISO5835,andISO9268.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E18TestMethodsforRockwellHardnessandRockwellSuperficialHardnessofMetallicMaterialsF90SpecificationforWroughtCobalt-20Chromium-15Tungsten-10NickelAlloyforSurgicalImplantApplica-tions(UNSR30605)F543SpecificationandTestMethodsforMetallicMedicalBoneScrewsF565PracticeforCareandHandlingofOrthopedicIm-plantsandInstrumentsF899SpecificationforStainlessSteelforSurgicalInstru-mentsF1744PracticeforCareandHandlingofStainlessSteelSurgicalInstruments2.2ISOStandards:5832-5ImplantsforSurgery—MetallicMaterials—Part5:WroughtCobalt-Chromium-Tungsten-NickelAlloy35835ImplantsforSurgery—MetalBoneScrewswithHex-agonalDriverConnection,SphericalUnderSurfaceofHead,AsymmetricalThread—Dimensions37153-1SurgicalInstruments—MetallicMaterials—Part1:StainlessSteel38319-1OrthopaedicInstruments—DriveConnections—Part1:KeysforUsewithScrewswithHexagonSocketHeads38319-2OrthopaedicInstruments—DriveConnections—Part2:ScrewdriversforSingleSlotHeadScrews,screwswithCruciateSlot,andCross-RecessedHeadScrews39268ImplantsforSurgery—MetalBoneScrewswithConi-calUnder-SurfaceofHead—Dimensions33.Classification3.1Thisspecificationincludesthefollowingtypesofbitsformedicalscrewdrivers:3.1.1TypeI—Single-slotbit.3.1.2TypeII—Cruciate-slotbit.3.1.3TypeIII—Cross-slot(ModifiedPhillips)bit.3.1.4TypeIV—Hexagonalbit.3.1.5TypeV—Squarebit.3.1.6TypeVI—Hexalobebit.4.DimensionsandTolerances4.1Screwdriverbitsconformingtothisspecificationshallbefabricatedinaccordancewiththedimensionsandtolerancesdescribedbelow:4.1.1TypeI—Single-slotscrewdriverbitsmustconformtothedimensionsandtolerancesprovidedinTable1,anddescribedinFig.1.4.1.2TypeII—Cruciate-slotscrewdriverbitsmustconformtothedimensionsandtolerancesprovidedinTable2,anddescribedinFig.2.4.1.3TypeIII—Cross-slot(ModifiedPhillips)screwdriverbitsmustconformtothedimensionsandtolerancesprovidedinFig.3.4.1.4TypeIV—HexagonalscrewdriverbitsmustconformtothedimensionsandtolerancesprovidedinTable3,anddescribedinFig.4.4.1.5TypeV—SquarescrewdriverbitsmustconformtothedimensionsprovidedinTable4,anddescribedinFig.5.1ThisspecificationisunderthejurisdictionofASTMCommitteeF04onMedicalandSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommitteeF04.21onOsteosynthesis.CurrenteditionapprovedApr.1,2004.PublishedApril2004.Originallyapprovedin1969.Lastpreviouseditionapprovedin2000asF116–00.2ForreferencedASTMstandards,visittheASTMwebsite,@astm.org.ForAnnualBookofASTMStandardsvolumeinformation,refertothestandard’sDocumentSummarypageontheASTMwebsite.3AvailablefromAmericanNationalStandardsInstitute(ANSI),25W.43rdSt.,4thFloor,NewYork,NY10036.1Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959,UnitedStates.4.1.6TypeVI—HexalobescrewdriverbitsmustconformtothedimensionsprovidedinTable5,anddescribedinFig.6.5.MaterialRequirements5.1Thebitandshaftportionofthescrewdrivershouldbefabricatedfromoneofthefollowingmaterials:5.1.1Martensiticstainlesssteel(SpecificationF899orISO7153-1).5.1.2ColdworkedCobalt-Chromium-Tungsten-Nickelal-loy(SpecificationF90orISO5832-5).5.2Thehardnessofthematerialofthebitandshaftportionshallbe45–55(stainlesssteel)or45–50(Cobalt-Chromium-Tungsten-Nickelalloy)whenmeasuredontheRockwellCscaleaccordingtotheproceduresdescribedinTestMethodsE18.5.3Theshaftshallbefirmlyfixedtoahandleofappropriatematerial.6.FinishandMarking6.1Thebitportionofthescrewdrivershallbefreeofnicks,dents,andscratches.6.2Whensizepermits,thefollowinginformationshouldbelegiblymarkedontheshaftorhandleofthescrewdriver(inorderofpreference):6.2.1Manufacturer’snameorlogo6.2.2Size(forTypeIVthroughVIscrewdriverbits)6.2.3Catalognumber6.2.4Manufacturinglotnumber6.2.5Material(includeASTMdesignation,asappropriate).6.3Themarkingshouldbesuchthatthemechanicalinteg-rityofthescrewdriverisnotcompromised.7.CareandHandling7.1ScrewdriversshouldbehandledinaccordancewithPracticesF565andF1744,asappropriate.8.Keywords8.1bonescrew;orthopaedicmedicaldevices;screwdriver;surgicalinstrumentsFIG.1DimensionsofSingle-SlotScrewdriverBitTABLE1DimensionsandToler