ASTM F2694-2007 活动腰椎全椎间盘假体的功能及磨损评定的标准实施规程

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【英文标准名称】:StandardPracticeforFunctionalandWearEvaluationofMotion-PreservingLumbarTotalFacetProstheses
【原文标准名称】:活动腰椎全椎间盘假体的功能及磨损评定的标准实施规程
【标准号】:ASTMF2694-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.25
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:评定;外科植入物;医疗技术学;运动;外科学;磨损
【英文主题词】:dynamictest;facetarthroplasty;posteriorinstrumentation;spinalimplants;statictest;wearassessment;weightlossmethod
【摘要】:TotalFacetProsthesisComponents8212;Thetotalfacetreplacementmaycompriseavarietyofshapesandconfigurations.Itsformsmayinclude,butarenotlimitedto,ballandsocketarticulatingjoints,jointshavingafree-floatingorsemi-constrainedthirdbody,metallicload-bearingsurfaces,andspringanddampeningmechanisms.Additionally,itmaybeaunilateralorbilateraldesign.SpinalTestingApparatus:TestChambers8212;Incaseofamultispecimenmachine,eachchambershallbeisolatedtopreventcross-contaminationofthetestspecimens.Thechambershallbemadeentirelyofcorrosionresistantmaterials,suchasacrylicplasticorstainlesssteel,andshallberemovablefromthemachineforthoroughcleaningbetweentests.ComponentClamping/Fixturing8212;Sincethepurposeofthetestistocharacterizethewearandkinematicfunctionofthetotalfacetprosthesis,themethodformountingcomponentsinthetestchambershallnotcompromisetheaccuracyofassessmentoftheweightlossorstiffnessvariationduringthetest.Forexample,prostheseshavingcomplicatedsuperiorandinferiorsurfacesforcontactingbone(forexample,sinteredbeads,hydroxylapatite(HA)coating,plasmaspray)maybespeciallymanufacturedtomodifythatsurfaceinamannerthatdoesnotaffectthewearsimulation.Thedeviceshouldbesecurely(rigidly)attachedatitsbone-implantinterfacetothematingtestfixtures.Themotionofthesuperiortestfixture(moreposteriorfixtureinFigs.1and2)relativetotheinferiortestingfixtureshallbeconstrainedinthree-dimensionalspaceexceptforthecomponentsinthedirectionofspecifiedtestmotions/loads.LoadandMotion:Facetloads(fx)areinitiallyappliedinthedirectionofthepositiveX-axis.FlexionloadandmotionarepositivemomentandrotationabouttheY-axis.ExtensionloadandmotionarenegativemomentandrotationabouttheY-axis.LateralbendloadandmotionarepositiveandnegativemomentsandrotationsabouttheX-axis.AxialrotationloadandmotionarepositiveandnegativemomentsandrotationsabouttheZ-axis.Frequency8212;Testfrequencyistobedeterminedandjustifiedbytheuserofthispractice,andshallnotexceed2Hzwithoutadequatejustificationensuringthattheappliedmotion(load)profilesremainwithinspecifiedtolerancesandthatthetotalfacetprosthesisx2019;swearandfunctionalcharacteristicsarenotsignificantlyaffected.SeeX1.6.CycleCounter8212;Onecompletemotionistheentirerangefromstartingpositionthroughtherangeofmotion(orloadwheninloadcontrol)andreturningtothestartingposition(load).Cyclesaretobecountedusinganautomatedcountingdevice.Note8212;Thissetupwouldrequiretworotationalactuatorsandonetranslationalactuator.FIG.1DiagramsofPossibleTestApparatusforAllowingSimultaneousLateralBendingandAxialRotationMotionswithAnterior-PosteriorDirectedFacetLoading