【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操作规程
【标准号】:ASTMF1984-1999(2003)
【标准状态】:现行
【国别】:
【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(ASTM)
【起草单位】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:生物配伍;血液兼容性;完整试验
【英文主题词】:biocompatibility;bloodcompatibility;wholecomplementtesting;
【摘要】:Inappropriateactivationofcomplementbyblood-contactingmedicaldevicesmayhaveseriousacuteorchroniceffectsonthehost.Thispracticeisusefulasasimple,inexpensivescreeningmethodfordeterminingfunctionalwholecomplementactivationbysolidmaterialsinvitro.Thispracticeiscomposedoftwoparts.InPartA(Section11),humanserumisexposedtoasolidmaterial.Complementmaybedepletedbytheclassicaloralternativepathways.Inprinciple,nonspecificbindingofcertaincomplementcomponentsalsomayoccur.Thealternativepathwaycandepletelateractingcomponentscommontobothpathways,thatiscomponentsotherthanC1,C4,andC3(1).4InPartB(Section12),complementactivityremainingintheserumafterexposuretothetestmaterialisassayedbyclassicalpathway-mediatedlysisofsensitizedRBC.Assessmentofinvitrowholecomplementactivation,asdescribedhere,providesonemethodforpredictingpotentialcomplementactivationbymedicalmaterialsintendedforclinicalapplicationinhumanswhenthematerialcontactstheblood.Othertestmethodsforcomplementactivationareavailable,includingassaysforspecificcomplementcomponentsandtheirsplitproducts(seeX1.3andX1.4).Thisinvitrotestmethodissuitableforadoptioninspecificationsandstandardsforscreeningsolidmaterialsforuseintheconstructionofmedicaldevicesintendedtobeimplantedinthehumanbodyorplacedincontactwithhumanblood.1.1Thispracticeprovidesaprotocolforrapid,invitroscreeningforwholecomplementactivatingpropertiesofsolidmaterialsusedinthefabricationofmedicaldevicesthatwillcontactblood.1.2Thispracticeisintendedtoevaluatetheacuteinvitrowholecomplementactivatingpropertiesofsolidmaterialsintendedforuseincontactwithblood.Forthispractice,thewords"serum"and"complement"areusedinterchangeably(mostbiologicalsupplyhousesusethesewordssynonymouslyinreferencetoserumusedasasourceofcomplement).1.3Thispracticeconsistsoftwoproceduralparts.ProcedureAdescribesexposureofsolidmaterialstoastandardlotofhumanserum,usinga0.1-mLserum/13x100-mmdisposabletesttube.Celluloseacetatepowdersandfibersareusedasexamplesoftestmaterials.ProcedureBdescribesassayingtheexposedserumforsignificantfunctionalwholecomplementdepletionascomparedtocontrolsamples.1.4Thispracticedoesnotaddressfunction,elaboration,ordepletionofindividualcomplementcomponents,nordoesitaddresstheuseofplasmaasasourceofcomplement.1.5Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748mayprovideguidancefortheselectionofappropriatemethodsfortestingmaterialsforotheraspectsofbiocompatibility.
【中国标准分类号】:C04
【国际标准分类号】:11_040_01
【页数】:5P.;A4
【正文语种】:


【英文标准名称】:Informationtechnology.Radiofrequencyidentificationdeviceconformancetestmethods.Testmethodsforairinterfacecommunicationsbelow135kHz
【原文标准名称】:信息技术.射频识别设备符合性试验方法.低于135kHz的空气接口通信的试验方法
【标准号】:BSISO/IEC18047-2-2012
【标准状态】:现行
【国别】:英国
【发布日期】:2012-02-29
【实施或试行日期】:2012-02-29
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Airinterfaces;Communication;Conformity;Conformitytesting;Definitions;Functionality;Identification;Informationtechnology;Interoperability;RadioFrequencyIdentification;Radiofrequencyidentifications;RFID;Testing;Tolerances(measurement)
【摘要】:
【中国标准分类号】:L71
【国际标准分类号】:35_240_60
【页数】:40P;A4
【正文语种】:英语