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【英文标准名称】:StandardTestMethodsforSpinalImplantConstructsinaVertebrectomyModel
【原文标准名称】:脊骨切除术模型中脊骨植入结构的标准试验方法
【标准号】:ASTMF1717-2004
【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】:试验方法;模型;外科植入物;机械试验
【英文主题词】:corpectomymodel;fatiguetestmethods;spinalimpantassembly;spinalimplantconstruct;statictestmethods
【摘要】:Spinalimplantsaregenerallycomposedofseveralcomponentswhich,whenconnectedtogether,formaspinalimplantassembly.Spinalimplantassembliesaredesignedtoprovidesomestabilitytothespinewhilearthrodesistakesplace.Thesetestmethodsoutlinestandardmaterialsandmethodsfortheevaluationofdifferentspinalimplantassembliessothatcomparisonbetweendifferentdesignsmaybefacilitated.Thesetestmethodsareusedtoquantifythestaticanddynamicmechanicalcharacteristicsofdifferentdesignsofspinalimplantassemblies.Themechanicaltestsareconductedinvitrousingsimplifiedloadschemesanddonotattempttomimicthecomplexloadsofthespine.Theloadsappliedtothespinalimplantassembliesinvivowill,ingeneral,differfromtheloadingconfigurationsusedinthesetestmethods.Theresultsobtainedherecannotbeuseddirectlytopredictinvivoperformance.Theresultscanbeusedtocomparedifferentcomponentdesignsintermsoftherelativemechanicalparameters.Fatiguetestinginasimulatedbodyfluidorsalinemaycausefretting,corrosion,orlubricatetheinterconnectionsandtherebyaffecttherelativeperformanceoftesteddevices.Thistestshouldbeinitiallyperformeddry(ambientroomconditions)forconsistency.Theeffectofenvironmentmaybesignificant.Repeatingallorpartofthesetestmethodsinsimulatedbodyfluid,saline(9gNaClper1000mLwater),asalinedrip,water,oralubricantshouldbeconsidered.Themaximumrecommendedfrequencyforthistypeofcyclictestingshouldbe5Hz.Thelocationofthelongitudinalelementsisdeterminedbywheretheanchorsareclinicallyplacedagainstbonystructures.Theperpendiculardistancetotheloaddirection(blockmomentarm)betweentheaxisofahingepinandtheanchor’attachment-pointstoaUHMWPEblockisindependentofanchor-type.Thedistancebetweentheanchor’attachmentpointtotheUHMWPEblockandthecenterofthelongitudinalelementisafunctionoftheinterfacedesignbetweenthescrew,hook,wire,cable,andsoforth,andtherod,plate,andsoforth.1.1Thesetestmethodscoverthematerialsandmethodsforthestaticandfatiguetestingofspinalimplantassembliesinavertebrectomymodel.Thetestmaterialsformostcombinationsofspinalimplantcomponentscanbespecificdependingontheintendedspinallocationandintendedmethodofapplicationtothespine.1.2Thesetestmethodsareintendedtoprovideabasisforthemechanicalcomparisonamongpast,present,andfuturespinalimplantassemblies.Theyallowcomparisonofspinalimplantconstructswithdifferentintendedspinallocationsandmethodsofapplicationtothespine.Thesetestmethodsarenotintendedtodefinelevelsofperformance,sincesufficientknowledgeisnotavailabletopredicttheconsequencesoftheuseofaparticulardevice.1.3Thesetestmethodssetoutguidelinesforloadtypesandmethodsofapplyingloads.Methodsforthreestaticloadtypesandonefatiguetestaredefinedforthecomparativeevaluationofspinalimplantassemblies.1.4Thesetestmethodsestablishguidelinesformeasuringdisplacements,determiningtheyieldload,andevaluatingthestiffnessandstrengthofthespinalimplantassembly.1.5Somespinalconstructsmaynotbetestableinalltestconfigurations.1.6ValuesstatedinSIunitsaretoberegardedasstandard.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:18P.;A4
【正文语种】: