ASTM F1984-1999(2008) 用固体材料测试血浆中整个活性的标准实施规程

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【英文标准名称】:StandardPracticeforTestingforWholeComplementActivationinSerumbySolidMaterials
【原文标准名称】:用固体材料测试血浆中整个活性的标准实施规程
【标准号】:ASTMF1984-1999(2008)
【标准状态】:现行
【国别】:美国
【发布日期】:1999
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:biocompatibility;bloodcompatibility;wholecomplementtesting;Bloodcompatibility;Complementactivation;Implantablesurgicalmaterials/applications;invitroEvaluation;Wholecomplementactivation;Biocompatibility
【摘要】:p>Inappropriateactivationofcomplementbyblood-contactingmedicaldevicesmayhaveseriousacuteorchroniceffectsonthehost.Thispracticeisusefulasasimple,inexpensivescreeningmethodfordeterminingfunctionalwholecomplementactivationbysolidmaterialsinvitro.Thispracticeiscomposedoftwoparts.InPartA(Section11),humanserumisexposedtoasolidmaterial.Complementmaybedepletedbytheclassicaloralternativepathways.Inprinciple,nonspecificbindingofcertaincomplementcomponentsalsomayoccur.Thealternativepathwaycandepletelateractingcomponentscommontobothpathways,thatiscomponentsotherthanC1,C4,andC3(1).InPartB(Section12),complementactivityremainingintheserumafterexposuretothetestmaterialisassayedbyclassicalpathway-mediatedlysisofsensitizedRBC.Assessmentofinvitrowholecomplementactivation,asdescribedhere,providesonemethodforpredictingpotentialcomplementactivationbymedicalmaterialsintendedforclinicalapplicationinhumanswhenthematerialcontactstheblood.Othertestmethodsforcomplementactivationareavailable,includingassaysforspecificcomplementcomponentsandtheirsplitproducts(seeX1.3andX1.4).Thisinvitrotestmethodissuitableforadoptioninspecificationsandstandardsforscreeningsolidmaterialsforuseintheconstructionofmedicaldevicesintendedtobeimplantedinthehumanbodyorplacedincontactwithhumanblood.1.1Thispracticeprovidesaprotocolforrapid,invitroscreeningforwholecomplementactivatingpropertiesofsolidmaterialsusedinthefabricationofmedicaldevicesthatwillcontactblood.1.2Thispracticeisintendedtoevaluatetheacuteinvitrowholecomplementactivatingpropertiesofsolidmaterialsintendedforuseincontactwithblood.Forthispractice,thewordsx201C;serumx201D;andx201C;complementx201D;areusedinterchangeably(mostbiologicalsupplyhousesusethesewordssynonymouslyinreferencetoserumusedasasourceofcomplement).1.3Thispracticeconsistsoftwoproceduralparts.ProcedureAdescribesexposureofsolidmaterialstoastandardlotofhumanserum,usinga0.1-mLserum/13x100-mmdisposabletesttube.Celluloseacetatepowdersandfibersareusedasexamplesoftestmaterials.ProcedureBdescribesassayingtheexposedserumforsignificantfunctionalwholecomplementdepletionascomparedtocontrolsamples.1.4Thispracticedoesnotaddressfunction,elaboration,ordepletionofindividualcomplementcomponents,nordoesitaddresstheuseofplasmaasasourceofcomplement.1.5Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748mayprovideguidancefortheselectionofappropriatemethodsfortestingmaterialsforotheraspectsofbiocompatibility.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.
【中国标准分类号】:C05
【国际标准分类号】:11_040_01
【页数】:5P.;A4
【正文语种】:英语