【英文标准名称】:StandardPracticeforFrettingCorrosionTestingofModularImplantInterfaces:HipFemoralHead-boreandConeTaperInterface
【原文标准名称】:模块植入接口的磨损侵蚀试验的标准操作规程:脊股骨孔和锥体锥形接口
【标准号】:ASTMF1875-1998(2004)
【标准状态】:现行
【国别】:
【发布日期】:1998
【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】:F04.15
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:碎片;孔和锥体;磨损侵蚀;总模数脊
【英文主题词】:boreandcone;debris;frettingcorrosion;modulartotalhips
【摘要】:Themodularinterfacesoftotaljointprosthesesaresubjectedtomicromotionthatcouldresultinfrettingandcorrosion.Thereleaseofcorrosionproductsandparticulatedebriscouldstimulateadversebiologicalreactions,aswellasleadtoacceleratedwearatthearticulationinterface.Methodstoassessthestabilityandcorrosionresistanceofthemodularinterfaces,therefore,areanessentialcomponentofdevicetesting.Long-terminvitrotestingisessentialtoproducedamageanddebrisfromfrettingofamodularinterface(4,5).Theuseofproteinaceoussolutionsisrecommendedtobestsimulatetheinvivoenvironment.Short-termtestsoftencanbeusefulinevaluationsofdifferencesindesignduringdevicedevelopment(1-4).Theelectrochemicalmethodsprovidesemiquantitativemeasuresoffrettingcorrosionrates.Therelativecontributionsofmechanicalandelectrochemicalprocessestothetotalcorrosionandparticulatereleasephenomena,however,havenotbeenestablished;therefore,thesetestsshouldnotbeutilizedtocomparetheeffectsofchangesinmaterialcombinations,butratherbeutilizedtoevaluatedesignchangesofbore(head)andcone(stem)components.Thesetestsarerecommendedforevaluatingthefrettingwearandcorrosionofmodularinterfacesofhipfemoralheadandstemcomponents.Similarmethodsmaybeappliedtoothermodularinterfaceswherefrettingcorrosionisofconcern.Thesemethodsarerecommendedforcomparativeevaluationofthefrettingwearandcorrosionofnewmaterials,coatings,ordesigns,oracombinationthereof,underconsiderationforhipfemoralheadandneckmodularinterfaces.Componentsfortestingmaybethoseofamanufacturedmodularhipdevice(finishedproduct)orsamplecoupons,whicharedesignedandmanufacturedforsimulationofthehead,taper,andneckregionofamodularhipdevice.1.1Thispracticedescribesthetesting,analytical,andcharacterizationmethodsforevaluatingthemechanicalstabilityoftheboreandconeinterfaceoftheheadandstemjunctionofmodularhipimplantssubjectedtocyclicloadingbymeasurementsoffrettingcorrosion.(1-5)Twotestmethodsdescribedareasfollows:1.1.1MethodI-Theprimarypurposeofthismethodistoprovideauniformsetofguidelinesforlong-termtestingtodeterminetheamountofdamagebymeasurementoftheproductionofcorrosionproductsandparticulatedebrisfromfrettingandfrettingcorrosion.Damagealsoisassessedbycharacterizationofthedamagetotheboreandconesurfaces.(4,5)1.1.2MethodsII-Thismethodprovidesforshort-termelectrochemicalevaluationofthefrettingcorrosionofthemodularinterface.Itisnottheintentofthismethodtoproducedamagenorparticulatedebrisbutrathertoprovidearapidmethodforqualitativeassessmentofdesignchangeswhichdonotincludematerialchanges.(1-4)1.2Thispracticedoesnotprovideforjudgmentorpredictionofinvivoimplantperformance,butrather,providesforauniformsetofguidelinesforevaluatingrelativedifferencesinperformancebetweendifferingimplantdesigns,constructs,ormaterialswithperformancedefinedinthecontextoftheamountoffrettingandfrettingcorrosion.Also,thispracticeshouldpermitdirectcomparisonoffrettingcorrosiondatabetweenindependentresearchgroups,andthus,provideforbuildingofadatabaseonmodularimplantperformance.1.3Thispracticeprovidesforcomparativetestingofmanufacturedhipfemoralheadsandstemsandforcoupontypespecimentestingwherethemaletaperportionofthemodularjunctiondoesnotincludetheentirehipimplant,withthetaperportion......
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:6P.;A4
【正文语种】: