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【英文标准名称】:StandardTestMethodsforStaticandDynamicCharacterizationofSpinalArtificialDiscs
【原文标准名称】:人造脊椎盘的静态和动态特性的标准试验方法
【标准号】:ASTMF2346-2005
【标准状态】:现行
【国别】:
【发布日期】:2005
【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】:特性记述;人工的;静态的;动态的;试验
【英文主题词】:artificialintervertebraldisc;dynamictestmethods;spinalimplants;statictestmethods
【摘要】:Artificialintervertebraldiscsareorthopaedicimplantsthatreplacedegeneratednaturalintervertebraldiscs.Theirfunctionistosupporttheanteriorcolumnofthespinewhileallowingmotionattheoperatedlevel.Thesetestmethodsoutlinematerialsandmethodsforthecharacterizationofthemechanicalperformanceofdifferentartificialintervertebraldiscssothatcomparisonscanbemadebetweendifferentdesigns.Thesetestmethodsaredesignedtoquantifythestaticanddynamiccharacteristicsofdifferentdesignsofartificialintervertebraldiscs.Thesetestsareconductedinvitroinordertoallowforanalysisofindividualdiscreplacementdevicesandcomparisonofthemechanicalperformanceofmultipleartificialintervertebraldiscdesignsinastandardmodel.Theloadsappliedtotheartificialintervertebraldiscsmaydifferfromthecomplexloadingseeninvivo,andtherefore,theresultsfromthesetestsmaynotdirectlypredictinvivoperformance.Theresults,however,canbeusedtocomparemechanicalperformanceofdifferentartificialintervertebraldiscs.Fatiguetestsshouldbeconductedina0.9%salineenvironmentalbathat37x00B0;Catarateof2Hzorless.Othertestenvironmentssuchasasimulatedbodyfluid,asalinedripormist,distilledwater,orothertypeoflubricationcouldalsobeusedwithadequatejustification.Likewise,alternativetestfrequenciesmaybeusedwithadequatejustification.Itiswellknownthatthefailureofmaterialsisdependentuponstress,testfrequency,surfacetreatments,andenvironmentalfactors.Therefore,whendeterminingtheeffectofchangingoneoftheseparameters(forexample,frequency,material,orenvironment),allothersshouldbekeptconstanttofacilitateinterpretationoftheresults.Inparticular,itmaybenecessarytoassesstheinfluenceoftestfrequencyondevicefracturewhileholdingthetestenvironment,implantmaterialsandprocessing,andimplantgeometryconstant.1.1Thesetestmethodsspecifythematerialsandmethodsforthestaticanddynamictestingofartificialintervertebraldiscs.1.2Thesetestmethodsareintendedtoprovideabasisforthemechanicalcomparisonamongpast,present,andfuturenon-biologicartificialintervertebraldiscs.Thesetestmethodsallowcomparisonofartificialintervertebraldiscswithdifferentintendedspinallocations(cervical,thoracic,andlumbar)andmethodsofapplicationtotheintervertebralspaces.Thesetestmethodsareintendedtoenabletheusertomechanicallycompareartificialintervertebraldiscsanddonotpurporttoprovideperformancestandardsforartificialintervertebraldiscs.1.3Thesetestmethodsdescribestaticanddynamictestsbyspecifyingloadtypesandspecificmethodsofapplyingtheseloads.Thesetestsaredesignedtoallowforthecomparativeevaluationofartificialintervertebraldiscs.1.4Thesetestmethodsdonotpurporttoaddressallclinicallyrelevantfailuremodesforartificialintervertebraldiscs,someofwhichwillbedevicespecific.Forexample,thesetestmethodsdonotaddresstheimplant''sresistancetoexpulsionorimplantwearresistanceunderexpectedinvivoloadsandmotions.Inaddition,thebiologicresponsetoweardebrisisnotaddressedinthesetestmethods.1.5Requirementsareestablishedformeasuringdisplacements,determiningtheyieldloadormoment,andevaluatingthestiffnessofartificialintervertebraldiscs.1.6Someartificialintervertebraldiscsmaynotbetestableinalltestconfigurations.1.7ThevaluesstatedinSIunitsaretoberegardedasthestandardwiththeexceptionofangularmeasurements,whichmayber......
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:10P.;A4
【正文语种】: