【英文标准名称】:Medicaldevicesutilizinganimaltissuesandtheirderivatives-Part3:Validationoftheeliminationand/orinactivationofvirusesandtransmissiblespongiformencephalopathy(TSE)agents(ISO22442-3:2007);EnglishversionofDINENISO22442-3:2008-0
【原文标准名称】:医疗设备用动物组织及其衍生物.第3部分:病毒和传染性海绵状脑病(TSE)试剂的消灭和/或失效的确认
【标准号】:DINENISO22442-3-2008
【标准状态】:现行
【国别】:德国
【发布日期】:2008-03
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:试剂;分析;动物产品;动物;应用;致病微生物;检验;收集;定义;衍生物;消灭;危害健康;杂质;钝性的;医疗产品;医学科学;方法;病原细菌;规程;生产;危险;危险分析;安全;规范(验收);组织;传染性海绵状脑病;使用;证实;病毒
【英文主题词】:Agents;Analysis;Animalproducts;Animals;Applications;Causativeorganisms;Checks;Collections;Definition;Definitions;Derivatives;Elimination;Healthhazards;Impurities;Inactive;Medicalproducts;Medicalsciences;Methods;Pathogenicbacteria;Procedures;Production;Risk;Riskanalysis;Safety;Specification(approval);Tissue;TSE;Use;Validation;Viruses
【摘要】:ThispartofISO22442specifiesrequirementsforthevalidationoftheeliminationand/orinactivationofvirusesandTSEagentsduringthemanufactureofmedicaldevices(excludinginvitrodiagnosticmedicaldevices)utilizinganimaltissueorproductsderivedfromanimaltissue,whicharenon-viableorhavebeenrenderednon-viable.ItapplieswhererequiredbytheriskmanagementprocessasdescribedinISO22442-1.Itdoesnotcoverothertransmissibleandnon-transmissibleagents.NOTE1AnalysisandmanagementofriskisdescribedinISO22442-1.Conventionalprocessesusedforsterilization,whenusedforthetreatmentofanimaltissuesformedicaldevices,havenotbeenshowntobecompletelyeffectiveininactivatingthecausativeagentsoftransmissiblespongiformencephalopathy.Selectivesourcingisextremelyimportant(seeISO22442-1andISO22442-2).NOTE2ISO11135,ISO11137,ISO11737-1,ISO13408,ISO14160,ISO14937andISO17665mayberelevantforbacteria,mouldsandyeast(seeBibliography).ThispartofISO22442doesnotcovertheutilizationofhumantissuesinmedicaldevices.ThispartofISO22442doesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.NOTE3ItisnotarequirementofthispartofISO22442tohaveafullqualitymanagementsystemduringmanufacture,butitdoesspecifyrequirementsforsomeoftheelementsofaqualitymanagementsystem.Attentionisdrawntothestandardsforqualitymanagementsystems(seeISO13485)thatcontrolallstagesofproductionorreprocessingofmedicaldevices.ThequalitymanagementsystemelementsthatarerequiredbythispartofISO22442canformpartofaqualitymanagementsystemconformingtoISO13485.ThispartofISO22442doesnotconsidertheeffectofanymethodofeliminationand/orinactivationonthesuitabilityofthemedicaldeviceforitsintendeduse.
【中国标准分类号】:C37
【国际标准分类号】:11_100_99
【页数】:29P.;A4
【正文语种】:英语