【英文标准名称】:StandardTestMethodforWearTestingofPolymericMaterialsUsedinTotalJointProstheses
【原文标准名称】:在全连接假肢上对聚合材料的磨耗试验的标准试验方法
【标准号】:ASTMF732-2000(2006)
【标准状态】:现行
【国别】:
【发布日期】:2000
【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】:(TestMethod)
【标准水平】:()
【中文主题词】:连接件;评定;摩擦;回程缸;材料;高聚物;特性;修复装置;密封;密封件;试验;轮胎;磨损
【英文主题词】:jointprosthesismaterials;pin-on-disk;weartesting
【摘要】:Thistestmethodisintendedtobeperformedinconjunctionwithpin-on-flatwearmachinesorsimilarmachinesthataredesignedtoevaluatesimplifiedspecimengeometries.Thistestmethodisdesignedtoevaluatecombinationsofmaterialswithrespecttotheamountofpolymerwear,wherequantifiablewearoccursprimarilyonthepolymericcomponent.Withsomecombinationsofmaterials,significantwearofthecounterfacemayoccur,withsubsequentembeddingofcounterfacedebrisparticlesinthepolymer.Suchanoccurrencewillrendertheweightlossofthepolymerspecimenunreliableasanindicatorofthepolymerwear.Wearisreportedasvolumelossofthepolymericspecimenasafunctionofslidingdistance;however,iftheslidingdistanceisnotconstantacrossthepolymericspecimensurfaceduetocomplexmotionpatterns,wearmaybereportedasvolumelossofthepolymericspecimenasafunctionofwearcycles(inwhichcaseax201C;wearcyclex201D;shallbedefined).Volumelossofthepolymerspecimenisdeterminedbydividingtheexperimentalweightlossbythedensityofthepolymer.Foreaseofinterpretation,wearshouldbereportedasafunctionofboththenumberofwearcyclesandtheslidingdistance,whenpossible.Thereferenceforthecomparativeevaluationofcandidatematerialsshallbethewearrateofultra-high-molecular-weightpolyethylene(UHMWPE)conformingtoSpecificationF648bearingagainstcounterfacesofcobalt-chromium-molybdenumalloy(inaccordancewithSpecificationsF75,F799,orF1537),havingprosthetic-qualitysurfacefinishandlubricatedwithbovinebloodserum(see5.2).1.1Thistestmethoddescribesalaboratorymethodforevaluatingthewearpropertiesofcombinationsofmaterialsthatarebeingconsideredforuseasbearingsurfacesofhumantotaljointprostheses.Thebodyofthistestmethodcontainsgeneralmethodswhichapplytoalltypesofprosthesiswearapplicationswhileindividualannexesdescribespecificweartestmethodsandclinicalvalidationcriteriatailoredtoeachdistinctwearapplication(forexample,linearreciprocatingmotion,ball-cup("hip-type")wear,delaminationwear,etc.).Itistheintentofthistestmethodtorankmaterials,withineachwearapplication,forpolymerwearratesundersimulatedphysiologicalconditions.Itmustberecognized,however,thatcontactgeometriesandwearmotionsaresimplifiedusingsuchmethods.Thistestmethod,therefore,representsonlyaninitialstageinthefullwearcharacterizationofacandidatematerial.1.2Allcandidatematerialsshouldbetestedinanappropriatejointsimulatorapparatususingprototypeprosthesesbeforebeingusedinclinicaltrialsinpatients.Thetestsdescribedinthistestmethodareusedtoquicklyandreliablyscreenmaterialcombinationsforwearperformanceindifferentorthopaedicwearapplicationspriortocommittingthemtomoreexpensiveandtime-consumingjointsimulatortesting.Inaddition,thesesimplifiedtestscanbeusedtorelatematerial,surfacefinish,orotherparameterstowearbehavioronamorepracticalbasisthanispossibleinjointsimulatortests.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:10P.;A4
【正文语种】: