ASTM F2077-2003 椎间体融合设备的试验方法

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【英文标准名称】:TestMethodsForIntervertebralBodyFusionDevices
【原文标准名称】:椎间体融合设备的试验方法
【标准号】:ASTMF2077-2003
【标准状态】:现行
【国别】:
【发布日期】:2003
【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】:dynamictestmethods;intervertebralbodyfusiondevice;spinalimplants;statictestmethods
【摘要】:1.1Thistestmethodcoversthematerialsandmethodsforthestaticanddynamictestingofintervertebralbodyfusiondeviceassemblies,spinalimplantsdesignedtopromotearthrodesisatagivenspinalmotionsegment.1.2Thistestmethodisintendedtoprovideabasisforthemechanicalcomparisonamongpast,present,andfuturenonbiologicintervertebralbodyfusiondeviceassemblies.Thistestmethodallowscomparisonofintervertebralbodyfusiondeviceassemblieswithdifferentintendedspinallocationsandmethodsofapplicationtotheintradiscalspaces.Thistestmethodisintendedtoenabletheusertocompareintervertebralbodyfusiondeviceassembliesmechanicallyanddoesnotpurporttoprovideperformancestandardsforintervertebralbodyfusiondeviceassemblies.1.3Thetestmethoddescribesstaticanddynamictestsbyspecifyingloadtypesandspecificmethodsofapplyingtheseloads.Thesetestsaredesignedtoallowforthecomparativeevaluationofintervertebralbodyfusiondeviceassemblies.1.4Thistestmethoddoesnotaddressexpulsiontestingofintervertebralbodyfusiondeviceassemblies(seeX1.11).1.5Guidelinesareestablishedformeasuringdisplacements,determiningtheyieldloadormoment,evaluatingthestiffness,andstrengthoftheintervertebralbodyfusiondeviceassemblies.1.6Someintervertebralbodyfusiondeviceassembliesmaynotbetestableinalltestconfigurations.1.7ThevaluesstatedinSIunitsaretoberegardedasthestandardwiththeexceptionofangularmeasurements,whichmaybereportedintermsofeitherdegreesorradians.1.8Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_20
【页数】:9P.;A4
【正文语种】: