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【英文标准名称】:StandardTestMethodforStatic,Dynamic,andWearAssessmentofExtra-DiscalSpinalMotionPreservingImplants
【原文标准名称】:防脊椎盘突出植入物静态、动态及磨损评定的标准试验方法
【标准号】:ASTMF2624-2007
【标准状态】:现行
【国别】:美国
【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】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:non-rigidextra-discalmotionpreservingdevice;posteriorinstrumentation;spinalimplant;wearassessment;weightlossmethod
【摘要】:Thistestmethodisdesignedtoquantifythestatic,dynamic,andwearcharacteristicsofdifferentdesignsofextra-discalmotionpreservingimplantsusingtestingmedium(see6.1)forsimulatingthephysiologicenvironmentat37x00B0;C.Wearisassessedusingaweightlossmethodinadditiontodimensionalanalyses.Weightlossisdeterminedaftersubjectingtheimplantstodynamicprofilesspecifiedinthistestmethod.Thisinformationwillallowthemanufacturerorenduseroftheproducttounderstandhowthespecificdeviceinquestionperformsunderthetestconditionsprescribedinthistestmethod.Thistestmethodisintendedtobeapplicableforextra-discalmotionpreservingimplants.Theseimplantsaugmentthemotion/loadbearingcharacteristicsbetweenadjacentvertebralbodies,andtherebyfullyorpartiallysupportandtransmitmotionbymeansofanarticulatingjointorbyuseofcompliantmaterials.Ceramics,metals,orpolymers,orcombinationsthereofareusedinimplantdesign,anditisthegoalofthistestmethodtoenableacomparisonofthestatic,dynamic,andwearpropertiesgeneratedbythesedevices,regardlessofmaterialandtypeofdevice.1.1Thistestmethodisintendedtoprovidetestmethodsforthestatic,dynamic,andweartestingofextra-discalmotionpreservingimplants.Theseimplantsareintendedtoaugmentspinalstabilitywithoutsignificanttissueremovalwhileallowingmotionofthefunctionalspinalunit(s).1.2Wearisassessedusingaweightlossmethodandadimensionalanalysisfordeterminingwearofcomponentsusedinextra-discalspinalmotionpreservingprocedures,usingtestingmediumasdefinedinthistestmethod(6.1).1.3Thistestmethodisnotintendedtoaddressanypotentialfailuremodeasitrelatestothefixationofthedevicetoitsbonyinterfaces.1.4Itistheintentofthistestmethodtoenablecomparisonofmotionpreserving,extra-discalimplantswithregardtokinematic,functional,andwearcharacteristicswhentestedunderthespecifiedconditions.Itmustberecognized,however,thattherearemanypossiblevariationsintheinvivoconditions.Asinglelaboratorysimulationwithafixedsetofparametersmaynotbeuniversallyrepresentative.1.5Thistestmethodisnotintendedtoaddressfacetarthroplastydevices.1.6Thistestmethodprescribestheuseofpureangularrotationsforassessingthemechanicalcharacteristicsofextra-discalmotionpreservingimplants.Thistestmethoddoesnot,however,prescribemethodsforassessingthemechanicalcharacteristicsofthedeviceintranslation(forexample,anterior/posteriortranslation),thoughthistypeoflinearmotionmaybeclinicallyrelevant.1.7Inorderthatthedatabereproducibleandcomparablewithinandbetweenlaboratories,itisessentialthatuniformproceduresareestablished.Thistestmethodisintendedtofacilitateuniformtestingmethodsanddatareportingforextra-discalmotionpreservingimplants.1.8Withoutasubstantialclinicalretrievalhistoryofspinal,motionpreservingextra-discalimplants,actualloadingprofilesandpatternscannotbedelineatedatthetimeofthewritingofthistestmethod.Itthereforefollowsthatthemotionprofilesspecifiedbythistestmethoddonotnecessarilyaccuratelyreproducethoseoccurringinvivo.Ratherthismethodprovidesusefulboundary/endpointconditionsforevaluatingimplantdesignsinafunctionalmanner.1.9Thistestmethodisnotintendedtobeaperformancestandard.Itistheresponsibilityoftheuserofthistestmethodtocharacterizethesafetyandeffectivenessofthedeviceunder......
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:11P.;A4
【正文语种】:英语