2024年5月19日发(作者：萧霞飞)
Designation:F543–07
StandardSpecificationandTestMethodsfor
MetallicMedicalBoneScrews
1
ThisstandardisissuedunderthefixeddesignationF543;thenumberimmediatelyfollowingthedesignationindicatestheyearof
originaladoptionor,inthecaseofrevision,rinparenthesesindicatestheyearoflastreapproval.A
superscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.
--``,,,,,,```,`,,``,``,,`,,,`-`-`,,`,,`,`,,`---
ThisstandardhasbeenapprovedforusebyagenciesoftheDepartmentofDefense.
1.1Thisspecificationprovidesrequirementsformaterials,
finishandmarking,careandhandling,andtheacceptable
dimensionsandtolerancesformetallicbonescrewsthatare
ensionsandtolerancesinthis
specificationareapplicableonlytometallicbonescrews
describedinthisspecification.
1.2Thisspecificationprovidesperformanceconsiderations
andstandardtestmethodsformeasuringmechanicalproperties
intorsionofmetallicbonescrewsthatareimplantedintobone.
Thesetestmethodsmayalsobeapplicabletootherscrews
besidesthosewhosedimensionsandtolerancesarespecified
lowingannexesareincluded:
1.2.1
AnnexA1—TestMethodforDeterminingtheTor-
sionalPropertiesofMetallicBoneScrews.
1.2.2
AnnexA2—TestMethodforDrivingTorqueofMedi-
calBoneScrews.
1.2.3AnnexA3—TestMethodforDeterminingtheAxial
PulloutStrengthofMedicalBoneScrews.
1.2.4
AnnexA4—TestMethodforDeterminingtheSelf-
TappingPerformanceofSelf-TappingMedicalBoneScrews.
1.2.5AnnexA5—SpecificationsforTypeHAandTypeHB
MetallicBoneScrews.
1.2.6AnnexA6—SpecificationsforTypeHCandTypeHD
MetallicBoneScrews.
1.2.7AnnexA7—SpecificationsforMetallicBoneScrew
DriveConnections.
1.3Thisspecificationisbased,inpart,uponISO5835,ISO
6475,andISO9268.
1.4Unlessotherwiseindicated,thevaluesstatedinSIunits
uesinparenthesesare
givenforinformationonly.
1.5Thisstandardmayinvolvetheuseofhazardousmate-
rials,operations,andarddoesnot
purporttoaddressallofthesafetyconcerns,ifany,associated
eresponsibilityoftheuserofthisstandard
ThisspecificationisunderthejurisdictionofASTMCommitteeF04on
MedicalandSurgicalMaterialsandDevicesandisthedirectresponsibilityof
SubcommitteeOsteosynthesis.
CurrenteditionapprovedJune1,ally
eviouseditionapprovedin2002asF543–02
e1
.
1
toestablishappropriatesafetyandhealthpracticesand
determinetheapplicabilityofregulatorylimitationspriorto
use.
ncedDocuments
2.1ASTMStandards:
2
E4PracticesforForceVerificationofTestingMachines
E6TerminologyRelatingtoMethodsofMechanicalTest-
ing
E8TestMethodsforTensionTestingofMetallicMaterials
E122PracticeforCalculatingSampleSizetoEstimate,
WithaSpecifiedTolerableError,theAveragefora
CharacteristicofaLotorProcess
F67SpecificationforUnalloyedTitanium,forSurgical
ImplantApplications(UNSR50250,UNSR50400,UNS
R50550,UNSR50700)
F86PracticeforSurfacePreparationandMarkingofMe-
tallicSurgicalImplants
F116SpecificationforMedicalScrewdriverBits
F136SpecificationforWroughtTitanium-6Aluminum-
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
ImplantApplications(UNSR56401)
F138SpecificationforWrought18Chromium-14Nickel-
2.5MolybdenumStainlessSteelBarandWireforSurgical
Implants(UNSS31673)
F565PracticeforCareandHandlingofOrthopedicIm-
plantsandInstruments
F620SpecificationforAlphaPlusBetaTitaniumAlloy
ForgingsforSurgicalImplants
F799SpecificationforCobalt-28Chromium-6Molybdenum
AlloyForgingsforSurgicalImplants(UNSR31537,
R31538,R31539)
F983PracticeforPermanentMarkingofOrthopaedicIm-
plantComponents
F1295SpecificationforWroughtTitanium-6Aluminum-
7NiobiumAlloyforSurgicalImplantApplications(UNS
R56700)
ForreferencedASTMstandards,visittheASTMwebsite,,or
contactASTMCustomerServiceatservice@ualBookofASTM
Standardsvolumeinformation,refertothestandard’sDocumentSummarypageon
theASTMwebsite.
2
Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959,UnitedStates.
1
F543–07
F1314SpecificationforWroughtNitrogenStrengthened22
Chromium−13Nickel−5Manganese−2.5Molybdenum
StainlessSteelAlloyBarandWireforSurgicalImplants
(UNSS20910)
F1472SpecificationforWroughtTitanium-6Aluminum-
4VanadiumAlloyforSurgicalImplantApplications(UNS
R56400)
F1537SpecificationforWroughtCobalt-28Chromium-6
MolybdenumAlloyforSurgicalImplants
F1586SpecificationforWroughtNitrogenStrengthened21
Chromium—10Nickel—3Manganese—2.5Molybdenum
StainlessSteelAlloyBarforSurgicalImplants(UNS
S31675)
F1713SpecificationforWroughtTitanium-13Niobium-
13ZirconiumAlloyforSurgicalImplantApplications
(UNSR58130)
F1813SpecificationforWroughtTitanium−12Molybde-
num−6Zirconium−2IronAlloyforSurgicalImplant(UNS
R58120)
F1839SpecificationforRigidPolyurethaneFoamforUse
asaStandardMaterialforTestingOrthopaedicDevices
andInstruments
2.2ISOStandards:
5835ImplantsforSurgery—MetalBoneScrewswithHex-
agonalDriverConnection,SphericalUnderSurfaceof
Head,AsymmetricalThread—Dimensions
3
6475ImplantsforSurgery—MetalBoneScrewswith
AsymmetricalThreadandSphericalUnder-Surface—
MechanicalRequirementsandTestMethods
3
9268ImplantsforSurgery—MetalBoneScrewswithConi-
calUnder-SurfaceofHead—Dimensions
3
ology
3.1Definitions—Someofthetermsdefinedinthissection
areshowninFig.1.
3.1.2breakingangle—angleofrotationwhenthescrew
failsintorsionasdemonstratedbyarapiddecreaseinthe
indicatedtorque.
3.1.3buttressthread—anasymmetricalthreadprofilechar-
acterizedbyapressureflankwhichisnearlyperpendicularto
thescrewaxis.
3.1.4cancellousscrew—ascrewdesignedprimarilytogain
lousscrewstypically
haveaHBthreadandmayormaynotbefullythreaded.
3.1.5corticalscrew—ascrewdesignedprimarilytogain
alscrewstypi-
callyhaveaHAthreadandarefullythreaded.
3.1.6corediameter—thesmallestdiameterofthethreaded
also
knownastheminordiameterorrootdiameter.
3.1.7gagelength—thedistancebetweentheholdingdevice,
forexample,asplitcollet,andtheundersideofthescrewhead.
3.1.8griplength—thelengthofthreadsheldfastinthesplit
colletorotherholdingmechanism.
3.1.9insertiondepth—thethreadedlengthasinsertedinto
thetestblock.
3.1.10insertiontorque—theamountoftorquerequiredto
overcomethefrictionalforcebetweenthescrewandthe
materialusedfortestingwhiledrivingthescrewintothe
material.
3.1.11maximumtorque(N-m)—thelargestvalueoftorque
recordedduringtheperiodofrotationbeforescrewfailurein
torsionalshearwhentestedinaccordancewith
AnnexA1.
3.1.12nontappingscrew—ascrewthathasatipthatdoes
notcontainaflpingscrewsusuallyrequireatapto
beinsertedintothepilotholebeforetheinsertionofthescrew,
whenusedinmoderateorhardbone.
3.1.13partiallythreadedscrew—ascrewwhosethreaded
portiondoesnotextendfullyfromthescrewpointtothescrew
headbutinsteadhasasmoothshaftrunningbetweenthehead
andthreads.
3.1.14pilothole—theholedrilledintotheboneintowhich
otholeisnormallyslightly
largerthanthescrew’r,ifthescrewis
tobeusedtoprovidecompressionacrossafracture,aportion
ofthepilotholemaybelargertoallowforaclearancefit.
3.1.15pitch—thelengthbetweenthethreadcrests.
3.1.16removaltorque—theamountoftorquerequiredto
overcomethefrictionalforcebetweenthescrewandthe
materialusedfortestingwhileremovingthescrewfromthe
material(forexample,counterclockwiserotationforright-hand
thread).
3.1.17screwhead—theendofthescrewwhichisopposite
ofthetipandfromwhichthemeansofinsertingthescrewis
coupled.
3.1.18screwlength—theoveralllengthofthescrewmea-
suredfromthescrewheadtothescrewtip.
3.1.19screwthread—ahelicalgrooveonacylindricalor
jectinghelicalridgethusformedis
calledascrewthread,consistingofpeaks(crests)andvalleys
(roots).
2
FIG.1SchematicofScrewTerms
3.1.1axialpulloutstrength—thetensileforcerequiredto
failorremoveabonescrewfromamaterialintowhichthe
screwhasbeeninserted.
AvailablefromAmericanNationalStandardsInstitute,25W.43rdSt.,4th
Floor,NewYork,NY10036.
3
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2024年5月19日发(作者：萧霞飞)
Designation:F543–07
StandardSpecificationandTestMethodsfor
MetallicMedicalBoneScrews
1
ThisstandardisissuedunderthefixeddesignationF543;thenumberimmediatelyfollowingthedesignationindicatestheyearof
originaladoptionor,inthecaseofrevision,rinparenthesesindicatestheyearoflastreapproval.A
superscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.
--``,,,,,,```,`,,``,``,,`,,,`-`-`,,`,,`,`,,`---
ThisstandardhasbeenapprovedforusebyagenciesoftheDepartmentofDefense.
1.1Thisspecificationprovidesrequirementsformaterials,
finishandmarking,careandhandling,andtheacceptable
dimensionsandtolerancesformetallicbonescrewsthatare
ensionsandtolerancesinthis
specificationareapplicableonlytometallicbonescrews
describedinthisspecification.
1.2Thisspecificationprovidesperformanceconsiderations
andstandardtestmethodsformeasuringmechanicalproperties
intorsionofmetallicbonescrewsthatareimplantedintobone.
Thesetestmethodsmayalsobeapplicabletootherscrews
besidesthosewhosedimensionsandtolerancesarespecified
lowingannexesareincluded:
1.2.1
AnnexA1—TestMethodforDeterminingtheTor-
sionalPropertiesofMetallicBoneScrews.
1.2.2
AnnexA2—TestMethodforDrivingTorqueofMedi-
calBoneScrews.
1.2.3AnnexA3—TestMethodforDeterminingtheAxial
PulloutStrengthofMedicalBoneScrews.
1.2.4
AnnexA4—TestMethodforDeterminingtheSelf-
TappingPerformanceofSelf-TappingMedicalBoneScrews.
1.2.5AnnexA5—SpecificationsforTypeHAandTypeHB
MetallicBoneScrews.
1.2.6AnnexA6—SpecificationsforTypeHCandTypeHD
MetallicBoneScrews.
1.2.7AnnexA7—SpecificationsforMetallicBoneScrew
DriveConnections.
1.3Thisspecificationisbased,inpart,uponISO5835,ISO
6475,andISO9268.
1.4Unlessotherwiseindicated,thevaluesstatedinSIunits
uesinparenthesesare
givenforinformationonly.
1.5Thisstandardmayinvolvetheuseofhazardousmate-
rials,operations,andarddoesnot
purporttoaddressallofthesafetyconcerns,ifany,associated
eresponsibilityoftheuserofthisstandard
ThisspecificationisunderthejurisdictionofASTMCommitteeF04on
MedicalandSurgicalMaterialsandDevicesandisthedirectresponsibilityof
SubcommitteeOsteosynthesis.
CurrenteditionapprovedJune1,ally
eviouseditionapprovedin2002asF543–02
e1
.
1
toestablishappropriatesafetyandhealthpracticesand
determinetheapplicabilityofregulatorylimitationspriorto
use.
ncedDocuments
2.1ASTMStandards:
2
E4PracticesforForceVerificationofTestingMachines
E6TerminologyRelatingtoMethodsofMechanicalTest-
ing
E8TestMethodsforTensionTestingofMetallicMaterials
E122PracticeforCalculatingSampleSizetoEstimate,
WithaSpecifiedTolerableError,theAveragefora
CharacteristicofaLotorProcess
F67SpecificationforUnalloyedTitanium,forSurgical
ImplantApplications(UNSR50250,UNSR50400,UNS
R50550,UNSR50700)
F86PracticeforSurfacePreparationandMarkingofMe-
tallicSurgicalImplants
F116SpecificationforMedicalScrewdriverBits
F136SpecificationforWroughtTitanium-6Aluminum-
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
ImplantApplications(UNSR56401)
F138SpecificationforWrought18Chromium-14Nickel-
2.5MolybdenumStainlessSteelBarandWireforSurgical
Implants(UNSS31673)
F565PracticeforCareandHandlingofOrthopedicIm-
plantsandInstruments
F620SpecificationforAlphaPlusBetaTitaniumAlloy
ForgingsforSurgicalImplants
F799SpecificationforCobalt-28Chromium-6Molybdenum
AlloyForgingsforSurgicalImplants(UNSR31537,
R31538,R31539)
F983PracticeforPermanentMarkingofOrthopaedicIm-
plantComponents
F1295SpecificationforWroughtTitanium-6Aluminum-
7NiobiumAlloyforSurgicalImplantApplications(UNS
R56700)
ForreferencedASTMstandards,visittheASTMwebsite,,or
contactASTMCustomerServiceatservice@ualBookofASTM
Standardsvolumeinformation,refertothestandard’sDocumentSummarypageon
theASTMwebsite.
2
Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959,UnitedStates.
1
F543–07
F1314SpecificationforWroughtNitrogenStrengthened22
Chromium−13Nickel−5Manganese−2.5Molybdenum
StainlessSteelAlloyBarandWireforSurgicalImplants
(UNSS20910)
F1472SpecificationforWroughtTitanium-6Aluminum-
4VanadiumAlloyforSurgicalImplantApplications(UNS
R56400)
F1537SpecificationforWroughtCobalt-28Chromium-6
MolybdenumAlloyforSurgicalImplants
F1586SpecificationforWroughtNitrogenStrengthened21
Chromium—10Nickel—3Manganese—2.5Molybdenum
StainlessSteelAlloyBarforSurgicalImplants(UNS
S31675)
F1713SpecificationforWroughtTitanium-13Niobium-
13ZirconiumAlloyforSurgicalImplantApplications
(UNSR58130)
F1813SpecificationforWroughtTitanium−12Molybde-
num−6Zirconium−2IronAlloyforSurgicalImplant(UNS
R58120)
F1839SpecificationforRigidPolyurethaneFoamforUse
asaStandardMaterialforTestingOrthopaedicDevices
andInstruments
2.2ISOStandards:
5835ImplantsforSurgery—MetalBoneScrewswithHex-
agonalDriverConnection,SphericalUnderSurfaceof
Head,AsymmetricalThread—Dimensions
3
6475ImplantsforSurgery—MetalBoneScrewswith
AsymmetricalThreadandSphericalUnder-Surface—
MechanicalRequirementsandTestMethods
3
9268ImplantsforSurgery—MetalBoneScrewswithConi-
calUnder-SurfaceofHead—Dimensions
3
ology
3.1Definitions—Someofthetermsdefinedinthissection
areshowninFig.1.
3.1.2breakingangle—angleofrotationwhenthescrew
failsintorsionasdemonstratedbyarapiddecreaseinthe
indicatedtorque.
3.1.3buttressthread—anasymmetricalthreadprofilechar-
acterizedbyapressureflankwhichisnearlyperpendicularto
thescrewaxis.
3.1.4cancellousscrew—ascrewdesignedprimarilytogain
lousscrewstypically
haveaHBthreadandmayormaynotbefullythreaded.
3.1.5corticalscrew—ascrewdesignedprimarilytogain
alscrewstypi-
callyhaveaHAthreadandarefullythreaded.
3.1.6corediameter—thesmallestdiameterofthethreaded
also
knownastheminordiameterorrootdiameter.
3.1.7gagelength—thedistancebetweentheholdingdevice,
forexample,asplitcollet,andtheundersideofthescrewhead.
3.1.8griplength—thelengthofthreadsheldfastinthesplit
colletorotherholdingmechanism.
3.1.9insertiondepth—thethreadedlengthasinsertedinto
thetestblock.
3.1.10insertiontorque—theamountoftorquerequiredto
overcomethefrictionalforcebetweenthescrewandthe
materialusedfortestingwhiledrivingthescrewintothe
material.
3.1.11maximumtorque(N-m)—thelargestvalueoftorque
recordedduringtheperiodofrotationbeforescrewfailurein
torsionalshearwhentestedinaccordancewith
AnnexA1.
3.1.12nontappingscrew—ascrewthathasatipthatdoes
notcontainaflpingscrewsusuallyrequireatapto
beinsertedintothepilotholebeforetheinsertionofthescrew,
whenusedinmoderateorhardbone.
3.1.13partiallythreadedscrew—ascrewwhosethreaded
portiondoesnotextendfullyfromthescrewpointtothescrew
headbutinsteadhasasmoothshaftrunningbetweenthehead
andthreads.
3.1.14pilothole—theholedrilledintotheboneintowhich
otholeisnormallyslightly
largerthanthescrew’r,ifthescrewis
tobeusedtoprovidecompressionacrossafracture,aportion
ofthepilotholemaybelargertoallowforaclearancefit.
3.1.15pitch—thelengthbetweenthethreadcrests.
3.1.16removaltorque—theamountoftorquerequiredto
overcomethefrictionalforcebetweenthescrewandthe
materialusedfortestingwhileremovingthescrewfromthe
material(forexample,counterclockwiserotationforright-hand
thread).
3.1.17screwhead—theendofthescrewwhichisopposite
ofthetipandfromwhichthemeansofinsertingthescrewis
coupled.
3.1.18screwlength—theoveralllengthofthescrewmea-
suredfromthescrewheadtothescrewtip.
3.1.19screwthread—ahelicalgrooveonacylindricalor
jectinghelicalridgethusformedis
calledascrewthread,consistingofpeaks(crests)andvalleys
(roots).
2
FIG.1SchematicofScrewTerms
3.1.1axialpulloutstrength—thetensileforcerequiredto
failorremoveabonescrewfromamaterialintowhichthe
screwhasbeeninserted.
AvailablefromAmericanNationalStandardsInstitute,25W.43rdSt.,4th
Floor,NewYork,NY10036.
3
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