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【英文标准名称】:StandardTestMethodforMeasuringLoadInducedSubsidenceofanIntervertebralBodyFusionDeviceUnderStaticAxialCompression
【原文标准名称】:测量在静态轴向压缩下椎间体融接器件的负载引发衰耗的标准试验方法
【标准号】:ASTMF2267-2004
【标准状态】:现行
【国别】:
【发布日期】:2004
【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】:测定负荷;被感应的;轴向;压缩;熔化;静态的;脊柱;壳体
【英文主题词】:intervertebralbodyfusiondevice;spinalimplants;subsidenceandstaticaxialcompression
【摘要】:Intervertebralbodyfusiondevicesaregenerallysimplegeometricshapeddevices,whichareoftenporousorhollowinnature.Theirfunctionistosupporttheanteriorcolumnofthespinetofacilitatearthrodesisofthemotionsegment.Thistestmethodisdesignedtoquantifythesubsidencecharacteristicsofdifferentdesignsofintervertebralbodyfusiondevicessincethisisapotentialclinicalfailuremode.Thesetestsareconductedinvitroinordertosimplifythecomparisonofsimulatedvertebralbodysubsidenceinducedbytheintervertebralbodyfusiondevices.Thestaticaxialcompressiveloadsthatwillbeappliedtotheintervertebralbodyfusiondevicesandtestblockswilldifferfromthecomplexloadingseeninvivo,andtherefore,theresultsfromthistestmethodmaynotbeusedtodirectlypredictinvivoperformance.Theresults,however,canbeusedtocomparethevaryingdegreesofsubsidencebetweendifferentintervertebralbodyfusiondevicedesignsforagivendensityofsimulatedbone.Thelocationwithinthesimulatedvertebralbodiesandpositionoftheintervertebralbodyfusiondevicewithrespecttotheloadingaxiswillbedependentuponthedesignandmanufacturerrsquo;recommendationforimplantplacement.1.1Thistestmethodspecifiesthematerialsandmethodsfortheaxialcompressivesubsidencetestingofnon-biologicintervertebralbodyfusiondevices,spinalimplantsdesignedtopromotearthrodesisatagivenspinalmotionsegment.1.2Thistestmethodisintendedtoprovideabasisforthemechanicalcomparisonamongpast,present,andfuturenon-biologicintervertebralbodyfusiondevices.Thistestmethodallowscomparisonofintervertebralbodyfusiondeviceswithdifferentintendedspinallocationsandmethodsofapplicationtotheintradiscalspaces.Thistestmethodisintendedtoenabletheusertomechanicallycompareintervertebralbodyfusiondevicesanddoesnotpurporttoprovideperformancestandardsforintervertebralbodyfusiondevices.1.3Thistestmethoddescribesastatictestmethodbyspecifyingaloadtypeandaspecificmethodofapplyingthisload.Thistestisdesignedtoallowforthecomparativeevaluationofintervertebralbodyfusiondevices.1.4Guidelinesareestablishedformeasuringtestblockdeformationanddeterminingthesubsidenceofintervertebralbodyfusiondevices.1.5Units8212;ThevaluesstatedinSIunitsaretoberegardedasthestandardwiththeexceptionofangularmeasurements,whichmaybereportedintermsofeitherdegreesorradians.1.6Sincesomeintervertebralbodyfusiondevicesrequiretheuseofadditionalimplantsforstabilization,thetestingofthesetypesofimplantsmaynotbeinaccordancewiththemanufacturer''srecommendedusage.1.7Theuseofthisstandardmayinvolvetheoperationofpotentiallyhazardousequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:7P.;A4
【正文语种】: