【英文标准名称】:StandardPracticeforAcceleratedAgingofUltra-HighMolecularWeightPolyethyleneafterGammaIrradiationinAir
【原文标准名称】:空气中a－射线辐射后的超高分子重量聚乙烯加速老化的标准方法
【标准号】:ASTMF2003-2002(2008)
【标准状态】:现行
【国别】:美国
【发布日期】:2002
【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】:aging;oxidation;preconditioning;stability;UHMWPE;UHMWPE;ultra-highmolecularweightpolyethylene;Acceleratedaging/testing--surgicaldevices/applications;Polyethylene(PE)surgicalimplantapplications;Preconditioning;UHMWPE(ultra-highmolecul
【摘要】:ThispracticesummarizesamethodthatmaybeusedtoacceleratetheoxidationofUHMWPEcomponentsusingelevatedtemperatureandelevatedoxygenpressure.Underreal-timeconditions,suchasshelfagingandimplantation,oxidativechangestoUHMWPEaftersterilizationusinghighenergyradiationmaytakemonthsoryearstoproducechangesthatmayresultindeleteriousmechanicalperformance.Themethodoutlinedinthispracticepermitstheevaluationofoxidativestabilityinarelativelyshortperiodoftime(forexample,weeks).ThispracticemayalsobeusedtooxidizeUHMWPEtestspecimensandjointreplacementcomponentspriortocharacterizationoftheirphysical,chemical,andmechanicalproperties.Inparticular,thispracticemaybeusedforacceleratedagingofUHMWPEcomponentspriortoevaluationinahiporkneejointwearsimulatorasoutlinedinGuideF1714(hipwear),GuideF1715(kneewear),ISO14242(hipwear),orISO14243(kneewear),orcombinationthereof.1.1ItistheintentofthispracticetopermitaninvestigatortoevaluatetheoxidativestabilityofUHMWPEmaterialsasafunctionofprocessingandsterilizationmethod.Thispracticedescribesalaboratoryprocedureforacceleratedagingofultra-highmolecularweightpolyethylene(UHMWPE)specimensandcomponentsfortotaljointprostheses.TheUHMWPEisagedatelevatedtemperatureandatelevatedoxygenpressure,toaccelerateoxidationofthematerialandtherebyallowfortheevaluationofitslong-termchemicalandmechanicalstability.1.2Althoughtheaccelerated-agingmethoddescribedbythispracticewillpermitaninvestigatortocomparetheoxidativestabilityofdifferentUHMWPEmaterials,itisrecognizedthatthismethodmaynotpreciselysimulatethedegradativemechanismsforanimplantduringreal-timeshelfagingandimplantation.1.3Theacceleratedagingmethodspecifiedhereinhasbeenvalidatedbasedonoxidationlevelsexhibitedbycertainshelf-agedUHMWPEcomponentspackagedinairandsterilizedwithgammaradiation.ThemethodhasnotbeenshowntoberepresentativeofshelfagingwhentheUHMWPEispackagedinanenvironmentotherthanair.Forexample,thispracticehasnotbeendirectlycorrelatedwiththeshelflifeofcomponentsthathavebeensealedinalow-oxygenpackage,suchasnitrogen.ThispracticeisnotintendedtosimulateanychangethatmayoccurinUHMWPEfollowingimplantation.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Thevaluesgiveninparenthesesaremathematicalconversionstoinch-poundunitsthatareforinformationonlyandarenotconsideredstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G31
【国际标准分类号】:83_080_01
【页数】:4P.;A4
【正文语种】:英语