ASTM F 2077-03 Test Methods For Intervertebral Bod

Designation:F2077–03TestMethodsForIntervertebralBodyFusionDevices1ThisstandardisissuedunderthefixeddesignationF2077;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodcoversthematerialsandmethodsforthestaticanddynamictestingofintervertebralbodyfusiondeviceassemblies,spinalimplantsdesignedtopromotearthro-desisatagivenspinalmotionsegment.1.2Thistestmethodisintendedtoprovideabasisforthemechanicalcomparisonamongpast,present,andfuturenon-biologicintervertebralbodyfusiondeviceassemblies.Thistestmethodallowscomparisonofintervertebralbodyfusiondeviceassemblieswithdifferentintendedspinallocationsandmeth-odsofapplicationtotheintradiscalspaces.Thistestmethodisintendedtoenabletheusertocompareintervertebralbodyfusiondeviceassembliesmechanicallyanddoesnotpurporttoprovideperformancestandardsforintervertebralbodyfusiondeviceassemblies.1.3Thetestmethoddescribesstaticanddynamictestsbyspecifyingloadtypesandspecificmethodsofapplyingtheseloads.Thesetestsaredesignedtoallowforthecomparativeevaluationofintervertebralbodyfusiondeviceassemblies.1.4Thistestmethoddoesnotaddressexpulsiontestingofintervertebralbodyfusiondeviceassemblies(seeX1.11).1.5Guidelinesareestablishedformeasuringdisplacements,determiningtheyieldloadormoment,evaluatingthestiffness,andstrengthoftheintervertebralbodyfusiondeviceassem-blies.1.6Someintervertebralbodyfusiondeviceassembliesmaynotbetestableinalltestconfigurations.1.7ThevaluesstatedinSIunitsaretoberegardedasthestandardwiththeexceptionofangularmeasurements,whichmaybereportedintermsofeitherdegreesorradians.1.8Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:E4PracticesforForceVerificationofTestingMachines2E6TerminologyRelatingtoMethodsofMechanicalTest-ing2E1823TerminologyRelatingtoFatigueandFractureTest-ing2F1582TerminologyRelatingtoSpinalImplants33.Terminology3.1FordefinitionoftermsrefertoTerminologyE6,E1823,andF1582.3.2DefinitionsofTermsSpecifictoThisStandard:3.2.1coordinatesystem/axes,n—ThreeorthogonalaxesaredefinedbyTerminologyF1582.Thecenterofthecoordinatesystemislocatedatthegeometriccenteroftheintervertebralbodyfusiondeviceassembly.TheXYplaneistobisectthesagittalplaneanglebetweensuperiorandinferiorlines(sur-faces)thatareintendedtosimulatetheadjacentvertebralendplates.ThepositiveZaxisistobedirectedsuperiorly.ForcecomponentsparalleltotheXYplaneareshearcomponentsofloading.ThecompressiveaxialforceisdefinedtobethecomponentinthenegativeZdirection.TorsionalloadisdefinedtobethecomponentofmomentparalleltotheZaxis.3.2.2fatiguelife,n—Thenumberofcycles,N,thattheintervertebralbodyfusiondeviceassemblycansustainataparticularloadormomentbeforemechanicalorfunctionalfailureoccurs.3.2.3functionalfailure,n—Permanentdeformationthatrenderstheintervertebralbodyfusiondeviceassemblyinef-fectiveorunabletoresistloadand/ormaintainattachmentadequately.3.2.4idealinsertionlocation,n—Theimplantlocationwithrespecttothesimulatedinferiorandsuperiorvertebralbodies(polyacetalormetalblocks)dictatedbythetype,design,andmanufacturer’ssurgicalinstallationinstructions.1ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedicalandSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommitteeF04.25onSpinalDevices.CurrenteditionapprovedApr.10,2003.PublishedMay2003.Originallypublishedin2000.Lastpreviouseditionapprovedin2001asF2077-01.2AnnualBookofASTMStandards,Vol03.01.3AnnualBookofASTMStandards,Vol13.01.1Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959,UnitedStates.3.2.5intendedmethodofapplication,n—Intervertebralbodyfusiondeviceassembliesmaycontaindifferenttypesofstabilizinganchorssuchasthreads,spikes,andknurledsur-faces.Eachtypeofanchorhasanintendedmethodofappli-cationorattachmenttothespine.3.2.6intendedspinallocation,n—Theanatomicregionofthespineintendedfortheintervertebralbodyfusiondeviceassembly.Intervertebralbodyfusiondeviceassembliesmaybedesignedanddevelopedforspecificregionsofthespinesuchasthelumbar,thoracic,andcervicalspine.Also,thereexistsdifferentanatomicalpotentialsurgicalapproaches,whichwillresultindifferentimplantorientationatdifferentlevelsofthespine.3.2.7intervertebralbodyfusiondevice,n—Astructure(bio-logicorsynthetic)thatisplacedinthediscspacebetweentwoadjacentvertebralbodiestoprovidesupportforeventualarthrodesisofthetwoadjacentvertebralbodies.3.2.8intradiscalheight,n—Thestraight-linedistancealongtheZaxisbetweentheunalteredsimulatedvertebralbodies—minimumheightof4mmandamaximumheightof18mm.SeeFig.1.3.2.9loadpoint,n—Thepointthroughwhichtheresultantforceontheintervertebraldevicepasses(thatis,thegeometriccenterofthesuperiorfixture’ssphere)(Figs.2-5)