BS EN 13641-2002 消除和降低与体外诊断试剂有关的感染的危险性

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【英文标准名称】:Eliminationorreductionofriskofinfectionrelatedtoinvitrodiagnosticreagents
【原文标准名称】:消除和降低与体外诊断试剂有关的感染的危险性
【标准号】:BSEN13641-2002
【标准状态】:现行
【国别】:英国
【发布日期】:2002-05-27
【实施或试行日期】:2002-05-27
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:ThisEuropeanStandardspecifiesrequirementsrelatedtodesignandmanufactureinordertoeffectivelycontroltheriskofinfectioncausedbyinvitrodiagnosticreagentsincludingreagentproducts,calibrators,controlmaterialsandkits,hereinaftercalledIVDreagents.Thestandardisapplicabletoinvitrodiagnosticreagentscontainingmaterialofhumanorigin.Thestandardisalsoapplicabletoinvitrodiagnosticreagentscontainingmaterialsobtainedbybiotechnologyprocessesormaterialsofanimalorigin,inparticularinviewofrelevantzoonoses,whentheresultsofariskanalysisrevealthatthereisariskofhumaninfection.Thestandarddoesnotapplytothefollowing:-instrumentsandspecimenreceptacles;NOTE1ThepreventionofinfectionduetohandlingofbiologicalmaterialsthroughoutsuchequipmentisaddressedinotherrelevantInternationaland/orEuropeanStandards.-generalaspectsofworkers'protection;-transportationofinfectiousgoods;-disposalmeasures.NOTE2SomeofthemostrelevantdocumentsrelatingtoaspectsnotcoveredbythisstandardarelistedinBibliographyforinformation.
【中国标准分类号】:C05
【国际标准分类号】:11_100_10
【页数】:12P;A4
【正文语种】:英语