ASTM F1634-1995(2000) 聚合物基体复合材料和植入装置的实验室条件下环境调节标准实施规程

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【英文标准名称】:StandardPracticeforIn-VitroEnvironmentalConditioningofPolymerMatrixCompositeMaterialsandImplantDevices
【原文标准名称】:聚合物基体复合材料和植入装置的实验室条件下环境调节标准实施规程
【标准号】:ASTMF1634-1995(2000)
【标准状态】:现行
【国别】:
【发布日期】:1995
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.15
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:加速老化;复合物;纤维;环境调节;状态调节;外科设备;医疗的;外科植入物;高聚物;在实验室条件下;加速调节;实验室环境;聚合物基体复合材料;水分分析法;整形外科医疗设备;使用;试验;实施规程;植入设备
【英文主题词】:acceleratedconditioning;composite;diffusion;environmentalconditioning;fiber;implantdevices;moistureabsorption;polymer;
【摘要】:TheconditioningprocedurescoveredinthispracticeprovidemethodsforsaturatingPMCspecimensinaliquidenvironmentpriortoconductingothertestsforpropertyevaluation.Theconditioningmayaffectgeometricanddimensionalchangesinspecimens.Insomeseverecases,chemicalchangesmayoccurinthefiber,polymerandfiber-polymerinterphaseandinterface.CautionmustbetakenifProcedureB(10.2,ProcedureBx2014;AcceleratedMoistureSaturationatElevatedTemperature)isfollowedtoconditionPMCspecimensatanelevatedtemperature.Physicalandchemicalreactionsinmaterialsarenormallytemperaturedependent.Anincreaseinexperimentaltemperaturemayaccelerateadesirablemoisturediffusionprocess.However,elevatedtemperaturesabove37x00B0;Cmayalsocauseundesirablereactionsthatdonotrepresentappropriateresponsesofmaterialsat37x00B0;C.Consequently,apilotstudyisrecommendedinProcedureBtodetermineifaselectedelevatedtemperaturecanbeusedforacceleratedconditioning.Ifthepropertiesofmaterialsaredeterminedtobeirreversiblyaffectedbythispilotstudyattheselectedelevatedtemperature,theneitheranappropriatelowerelevatedtemperatureshouldbedeterminedbyrepeatingthepilotstudy,orProcedureBshouldnotbeused.1.1Thispracticecoverstwoproceduresforconditioningnon-absorbablepolymermatrixcomposite(PMC)materialsandimplantdevicesinaliquidenvironmenttoobtainastateofsaturation.1.2ThepurposeofthispracticeistostandardizemethodsandreportingproceduresforconditioningPMCmaterialsandimplantdevices(PMCspecimens)inauserselectedliquidenvironmentpriortoconductingsubsequenttests.Itisnotthepurposeofthispracticetodeterminethediffusioncoefficientsoractualsaturationlevelsofagivenliquidintothematerialsanddevices.Forthesedeterminations,otherprocedures,suchasTestMethodD5229,maybefollowed.1.3Diffusionofliquidintoasolidmaterialisaslowprocess.Whilethetimenecessarytoachievesaturationat37x00B0;Cmaybesufficientlyshortforthinspecimens,suchasfracturefixationplates,itmaybeprohibitivelylonginthicksections,suchasfemoralcomponentsforhiparthroplasty.However,thediffusionprocessmaybeacceleratedatanelevatedtemperature.Consequently,twoseparateprocedures(ProceduresAandB)arepresentedinthispractice.ProcedureAcoversexposingthespecimentothedesiredconditioningenvironmentat37x00B0;C.ProcedureBprescribesamethodtoacceleratethediffusionprocessbyconditioningthespecimenataselectedelevatedtemperature.1.4Thispracticedoesnotspecifythetestenvironmenttobeusedforconditioning.However,thepHvalueofimmersionliquidshallbemaintainedat7.4x00B1;0.2tosimulatetheinvivoenvironment.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】: