【英文标准名称】:StandardTestMethodforEvaluatingMobileBearingKneeDislocation
【原文标准名称】:活动衬垫膝关节置换的标准试验方法
【标准号】:ASTMF2724-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:
【摘要】:Thistestmethodisdesignedtoprovideastandardizedmethodtodeterminetheconstraintofmobile-bearingkneedesignswithregardstospin-outandspit-outofthemobilebearing.Similartoconstrainttestingoftotalknees(seeTestMethodF1223),itisimportanttonotethatthetestmethoddoesnotsimulatethesofttissuesandlaxityofthekneejoint,whichmaybekeyfactorsrelatedtotheoccurrenceofspin-outorspit-out.Forinstance,apatientwithgoodsofttissuerestraintswillperhapsrequirealowerspin-out/spit-outresistancewhereasapatientwithmajorbonelossordestroyedligamentousstructureswilllikelyrequireanimplantwithahigherspin-out/spit-outresistance.Therefore,theresultsfromthetestshouldbetakenintoaccountalongwiththeconditionofthepatientx2019;ssofttissuestodeterminetherelativesafetyforthedevice.1.1Thistestmethodisdesignedtoprovideastandardizedmethodtodeterminethedislocationresistanceofmobile-bearingkneedesignswithregardtofemoralcomponentdisassociationandspin-out/spit-outofthemobilebearinginsert.1.2Althoughthemethodologydescribeddoesnotreplicateallphysiologicalloadingconditions,itisameansofin-vitrocomparisonofmobilebearingkneedesignsandtheirabilitytoresistdislocationofthemobilebearingfromthefemoralortibialcomponentsunderstatedtestconditions.1.3Thetestmethodappliesonlytomobilebearingtotalkneedesigns.1.4ThevaluesstatedinSIunitsareregardedasstandard.Thevaluesgiveninparenthesesaremathematicalconversionstoinch-poundunitsthatareprovidedforinformationonlyandarenotconsideredstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:3P.;A4
【正文语种】:英语