ASTM F1717-2010 椎骨切除模型中脊骨植入结构的的标准试验方法

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【英文标准名称】:StandardTestMethodsforSpinalImplantConstructsinaVertebrectomyModel
【原文标准名称】:椎骨切除模型中脊骨植入结构的的标准试验方法
【标准号】:ASTMF1717-2010
【标准状态】:现行
【国别】:
【发布日期】:2010
【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】:疲劳试验方法;脊骨植入装配;脊骨植入结构;静态试验方法;椎骨切除模型;疲劳-外科植入材料;医疗保健提供模式;动态分析/测试;脊椎骨植入物;静态试验-整形材料/应用
【英文主题词】:fatiguetestmethods;spinalimplantassembly;spinalimplantconstruct;statictestmethods;vertebrectomymodel;Fatigue--surgicalimplantmaterials;Healthcaredeliverymodels;Dynamicanalysis/testing;Spinalimplants;Statictests--orthopaedicmater
【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''sattachment-pointstoaUHMWPEblockisindependentofanchor-type.Thedistancebetweentheanchor''sattachmentpointtotheUHMWPEblockandthecenterofthelongitudinalelementisafunctionoftheinterfacedesignbetweenthescrew,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.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpractices......
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:20P.;A4
【正文语种】: