ASTM F1875-1998(2009) 模块植入接口的磨损侵蚀试验的标准实施规程:脊股骨孔和锥体锥形接口

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【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实施规程:脊股骨孔和锥体锥形接口
【标准号】:ASTMF1875-1998(2009)
【标准状态】:现行
【国别】:美国
【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】:
【英文主题词】:boreandcone;debris;frettingcorrosion;modulartotalhips;Corrosion--surgicalimplants;Damageassessment--surgicalapplications;Frettingcorrosiontesting;Hipreplacementprosthesis;Modularprostheses
【摘要】:Themodularinterfacesoftotaljointprosthesesaresubjectedtomicromotionthatcouldresultinfrettingandcorrosion.Thereleaseofcorrosionproductsandparticulatedebriscouldstimulateadversebiologicalreactions,aswellasleadtoacceleratedwearatthearticulationinterface.Methodstoassessthestabilityandcorrosionresistanceofthemodularinterfaces,therefore,areanessentialcomponentofdevicetesting.Long-termin-vitrotestingisessentialtoproducedamageanddebrisfromfrettingofamodularinterface(4,5).Theuseofproteinaceoussolutionsisrecommendedtobestsimulatethein-vivoenvironment.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:1.1.1MethodI8212;Theprimarypurposeofthismethodistoprovideauniformsetofguidelinesforlong-termtestingtodeterminetheamountofdamagebymeasurementoftheproductionofcorrosionproductsandparticulatedebrisfromfrettingandfrettingcorrosion.Damageisalsoassessedbycharacterizationofthedamagetotheboreandconesurfaces(4,5).1.1.2MethodsII8212;Thismethodprovidesforshort-termelectrochemicalevaluationofthefrettingcorrosionofthemodularinterface.Itisnottheintentofthismethodtoproducedamagenorparticulatedebrisbutrathertoprovidearapidmethodforqualitativeassessmentofdesignchangeswhichdonotincludematerialchanges(1-4).1.2Thispracticedoesnotprovideforjudgmentorpredictionofin-vivoimplantperformance,butratherprovidesforauniformsetofguidelinesforevaluatingrelativedifferencesinperformancebetweendifferingimplantdesigns,constructs,ormaterialswithperformancedefinedinthecontextoftheamountoffrettingandfrettingcorrosion.Also,thispracticeshouldpermitdirectcomparisonoffrettingcorrosiondatabetweenindependentresearchgroups,andthusprovideforbuildingofadatabaseonmodularimplantperformance.1.3Thispractic......
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:6P.;A4
【正文语种】:英语