ASTM F1714-1996(2008) 模拟装置中修复设计的重力计磨损评估用的标准指南

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【英文标准名称】:StandardGuideforGravimetricWearAssessmentofProstheticHipDesignsinSimulatorDevices
【原文标准名称】:模拟装置中修复设计的重力计磨损评估用的标准指南
【标准号】:ASTMF1714-1996(2008)
【标准状态】:现行
【国别】:美国
【发布日期】:1996
【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】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:Bearingsurfaces;Gravimetricwearassessment;Hipreplacementprosthesis;Humanjointreplacementprostheses;Lubricants--surgical/medicalapplications;Prostheses;Simulatordevices;UHMWPE(ultra-highmolecularweightpolyethylene);Weartesting--surgi
【摘要】:Thisguideusesaweight-lossmethodofweardeterminationforthepolymericcomponentsusedwithhipjointprostheses,usingserumordemonstratedequivalentfluidforlubrication,andrunningunderadynamicloadprofilerepresentativeofthehumanhip-jointforcesduringwalking(1,2).Thebasisforthisweight-lossmethodforwearmeasurementwasoriginallydeveloped(3)forpin-on-diskwearstudies(seePracticeF732)andhasbeenextendedtototalhipreplacements(4,5)femoral-tibialkneeprostheses(6),andtofemoropatellarkneeprostheses(6,7).Whilewearresultsinachangeinthephysicaldimensionsofthespecimen,itisdistinctfromdimensionalchangesduetocreeporplasticdeformation,inthatweargenerallyresultsintheremovalofmaterialintheformofpolymericdebrisparticles,causingalossinweightofthespecimen.Thisguideformeasuringwearofthepolymericcomponentissuitableforvarioussimulatordevices.Thesetechniquescanbeusedwithmetal,ceramic,carbon,polymeric,andcompositecounterfacesbearingagainstapolymericmaterial(forexample,polyethylene,polyacetal,andsoforth).Thisweight-lossmethod,therefore,hasuniversalapplicationforwearstudiesoftotalhipreplacementsthatfeaturepolymericbearings.Thisweight-lossmethodhasnotbeenvalidatedforhigh-densitymaterialbearingsystems,suchasmetal-metal,carbon-carbon,orceramic-ceramic.Progressivewearofsuchrigidbearingcombinationsgenerallyhasbeenmonitoredusingalinear,variable-displacementtransducersorbyotherprofilometrictechniques.1.1Thisguidedescribesalaboratorymethodusingaweight-losstechniqueforevaluatingthewearpropertiesofmaterialsordevices,orboth,whicharebeingconsideredforuseasbearingsurfacesofhuman-hip-jointreplacementprostheses.Thehipprosthesesareevaluatedinadeviceintendedtosimulatethetribologicalconditionsencounteredinthehumanhipjoint,forexample,useofafluidsuchasbovineserum,orequivalentpseudosynovialfluidshowntosimulatesimilarwearmechanismsanddebrisgenerationasfoundinvivo,andtestfrequenciesof1Hzorless.1.2Sincethehipsimulatormethodpermitstheuseofactualimplantdesigns,materials,andphysiologicalload/motioncombinations,itcanrepresentamorephysiologicalsimulationthanbasicwear-screeningtests,suchaspin-on-disk(seePracticeF732)orring-on-disk(seeISO6474).1.3Itistheintentofthisguidetorankthecombinationofimplantdesignsandmaterialswithregardtomaterialwear-rates,undersimulatedphysiologicalconditions.Itmustberecognized,however,thattherearemanypossiblevariationsintheinvivoconditions,asinglelaboratorysimulationwithafixedsetofparametersmaynotbeuniversallyrepresentative.1.4Thereferencematerialsforthecomparativeevaluationofcandidatematerials,newdevices,orcomponents,oracombinationthereof,shallbethewearrateofextrudedorcompression-molded,ultra-highmolecularweight(UHMW)polyethylene(seeSpecificationF648)bearingagainststandardcounterfaces[stainlesssteel(seeSpecificationF138);cobalt-chromium-molybdenumalloy(seeSpecificationF75);thermomechanicallyprocessedcobaltchrome(seeSpecificationF799);aluminaceramic(seeSpecificationF603)],havingtypicalprostheticquality,surfacefinish,andgeometrysimilartothosewithestablishedclinicalhistory.Thesereferencematerialswillbetestedunderthesamewearconditionsasthec......
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:7P.;A4
【正文语种】:英语