ISO/TR 22442-4-2010 使用动物组织以及衍生产品的医疗设备.第4部分:传染性海绵状脑病(TSE)试剂的消灭和/或失效的原则以及那些过程的确认试验

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【英文标准名称】:Medicaldevicesutilizinganimaltissuesandtheirderivatives—Part4:Principlesforeliminationand/orinactivationoftransmissiblespongiformencephalopathy(TSE)agentsandvalidationassaysforthoseprocesses
【原文标准名称】:使用动物组织以及衍生产品的医疗设备.第4部分:传染性海绵状脑病(TSE)试剂的消灭和/或失效的原则以及那些过程的确认试验
【标准号】:ISO/TR22442-4-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-12-01
【实施或试行日期】:2010-12-01
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:ThisTechnicalReportofferssuggestionsfordesigningandconductingvalidationassaystohelpdetermineifprocessesusedinthemanufactureofmedicaldevicesderivedfromnon-viableanimaltissuesmightservetoreducetheriskofiatrogenictransmissionoftransmissiblespongiformencephalopathies(TSEs).TheTSE-removalmethodsusedtoprocessanimaltissuesshouldalsoreducetheriskoftransmittingTSEinfectionsvianon-viabletissuesofhumanorigin;thisTechnicalReportdoesnotaddressthisissue.SomecurrentinformationonhumantissuesandTSEsispresentedwhichmaybeappliedbyanalogytootheranimaltissues.ThisTechnicalReportdoesnotintendtoimplyaneedforvalidationofmethodsinvolvingspecificmaterialsidentifiedashavinga“negligiblerisk”ofcontaminationwithTSEagentsaslistedinAnnexCofISO22442-1:2007.ThisTechnicalReportisintendedtoclarifyfinaldraftinternationalstandardsincludedintheISO22442series,aswellasinISO14160.ThisTechnicalReportbuildsuponthespecificdiscussioninISO22442-3relativetoTSEagentsandattemptstosummarizethecurrentstateoftheartinthearenaofTSEagentelimination.AstheunderstandingofinactivationandeliminationofTSEagentsevolves,thisdocumentwillberevisedwhenpossible.
【中国标准分类号】:C37
【国际标准分类号】:11_100_20
【页数】:22P.;A4
【正文语种】:英语