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【英文标准名称】:StandardTestMethodsforDeterminationofStaticandCyclicFatigueStrengthofCeramicModularFemoralHeads
【原文标准名称】:预制陶瓷股骨头的静态和循环疲劳强度测定的标准试验方法
【标准号】:ASTMF2345-2003(2008)
【标准状态】:现行
【国别】:美国
【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】:F04.22
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:bore;ceramic;cone;fatigue;modularhead;static;strength;Ceramicheaddesigns;Cyclicfatiguetesting;Fatigue--surgicalimplantmaterials;Femoralsurgicalcomponents;Metalcones/conicalfittings;Modularprostheses;Staticfatiguetesting
【摘要】:Thesetestmethodscanbeusedtodeterminetheeffectsofheadandconematerials,designvariables,manufacturing,andotherconditionsonthestaticandcyclicload-carryingabilityofmodularfemoralheadsmountedontheconesoffemoralstemprostheses.Thesetestmethodsmayuseactualfemoralprosthesesorneck-conemodelsofsimplifiedgeometrywiththesamegeometricalandmaterialcharacteristicsasintheimplants.Ineithercase,thematchingmetallicconeregionofthetestspecimenselectedshallbeofthesamematerial,tolerances,andfinishingasthefinalfemoralstemprosthesis.Thestatictestdatamayyieldvaluableinformationabouttherelativestrengthsandmeritsofdifferentheadandconedesignsforparticularapplications.Duetothehighforcesanticipatedforthistypeofdestructivetest(>40kN),theboundaryconditionsandloadlevelsfarexceedpossibleinvivoloadingparametersandthereforemaynotnecessarilybeapplicableasaquantitativeindicatorofexpectedinvivodeviceperformance.Inthefatiguetestmethods,itisrecognizedthatactualloadinginvivoisquitevaried,andthatnoonesetofexperimentalconditionscanencompassallpossiblevariations.Thus,thetestmethodsincludedhererepresentasimplifiedmodelforthepurposesofcomparisonsbetweendesignsandmaterials.Thesetestmethodsareintendedtobeperformedinair.Thetestdatamayyieldvaluableinformationabouttherelativestrengthsofdifferentheadandconedesigns.1.1Thesetestmethodscovertheevaluationofthestaticandcyclicfatiguestrengthofceramicmodularfemoralheads,mountedonaconeasusedonthefemoralstemofthetotalhiparthroplasty.1.2Thesetestmethodswereprimarilydevelopedforevaluationofceramic(SpecificationsF603andF1873)headdesignsonmetalconesbutmayhaveapplicationtoothermaterials.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:8P.;A4
【正文语种】:英语