ISO 22442-2-2007 医疗设备用动物组织及其衍生物.第2部分:来源控制、采集和处理
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【英文标准名称】:Medicaldevicesutilizinganimaltissuesandtheirderivatives-Part2:Controlsonsourcing,collectionandhandling
【原文标准名称】:医疗设备用动物组织及其衍生物.第2部分:来源控制、采集和处理
【标准号】:ISO22442-2-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-12-01
【实施或试行日期】:
【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】:分析;动物产品;动物;应用;检验;收集;定义;诱导生成物;搬运;杂质;医疗产品;医学科学;方法;病原细菌;规程;生产;危险;危险分析;采集;规范(验收);储存;组织;运输;使用;回采(煤)
【英文主题词】:Analysis;Animal;Animalproducts;Animals;Applications;Biologicalhazards;Bovines;Certification;Checks;Collections;Definitions;Derivatives;Fabrics;Feeding;Handling;Impurities;Information;Investigations;Medicaldevices;Medicalproducts;Medicalsciences;Methods;Origin;Pathogenicbacteria;Personnel;Procedures;Production;Quality;Risk;Riskanalysis;Selection;Specification(approval);Storage;Tissue;Transport;Use;Veterinarians;Winning
【摘要】:ThispartofISO22442specifiesrequirementsforcontrolsonthesourcing,collectionandhandling(whichincludesstorageandtransport)ofanimalsandtissuesforthemanufactureofmedicaldevicesutilizingmaterialsofanimalorigin,otherthaninvitrodiagnosticmedicaldevices.ItapplieswhererequiredbytheriskmanagementprocessasdescribedinISO22442-1.NOTE1Selectivesourcingisconsideredtobeespeciallyimportantfortransmissiblespongiformencephalopathy(TSE)riskmanagement.NOTE2ManufacturersshouldrefertoISO22442-3forinformationonthevalidationoftheeliminationand/orinactivationofvirusesandTSEagents.ThispartofISO22442doesnotcovertheutilizationofhumantissuesinmedicaldevices.ThispartofISO22442doesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.NOTE3ItisnotarequirementofthispartofISO22442tohaveafullqualitymanagementsystemduringmanufacture,butitdoesspecifyrequirementsforsomeoftheelementsofaqualitymanagementsystem.Attentionisdrawntothestandardsforqualitymanagementsystems(seeISO13485)thatcontrolallstagesofproductionorreprocessingofmedicaldevices.ThequalitymanagementsystemelementsthatarerequiredbythispartofISO22442canformapartofaqualitymanagementsystemconformingtoISO13485.NOTE4AgeneralprinciplefortheapplicationofISO22442isthatitisadvisabletogivedueconsiderationtotherequirementsandrecommendationscontainedinallthreepartsofthestandard.
【中国标准分类号】:C37
【国际标准分类号】:11_100_20
【页数】:24P.;A4
【正文语种】:英语
【原文标准名称】:医疗设备用动物组织及其衍生物.第2部分:来源控制、采集和处理
【标准号】:ISO22442-2-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-12-01
【实施或试行日期】:
【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】:分析;动物产品;动物;应用;检验;收集;定义;诱导生成物;搬运;杂质;医疗产品;医学科学;方法;病原细菌;规程;生产;危险;危险分析;采集;规范(验收);储存;组织;运输;使用;回采(煤)
【英文主题词】:Analysis;Animal;Animalproducts;Animals;Applications;Biologicalhazards;Bovines;Certification;Checks;Collections;Definitions;Derivatives;Fabrics;Feeding;Handling;Impurities;Information;Investigations;Medicaldevices;Medicalproducts;Medicalsciences;Methods;Origin;Pathogenicbacteria;Personnel;Procedures;Production;Quality;Risk;Riskanalysis;Selection;Specification(approval);Storage;Tissue;Transport;Use;Veterinarians;Winning
【摘要】:ThispartofISO22442specifiesrequirementsforcontrolsonthesourcing,collectionandhandling(whichincludesstorageandtransport)ofanimalsandtissuesforthemanufactureofmedicaldevicesutilizingmaterialsofanimalorigin,otherthaninvitrodiagnosticmedicaldevices.ItapplieswhererequiredbytheriskmanagementprocessasdescribedinISO22442-1.NOTE1Selectivesourcingisconsideredtobeespeciallyimportantfortransmissiblespongiformencephalopathy(TSE)riskmanagement.NOTE2ManufacturersshouldrefertoISO22442-3forinformationonthevalidationoftheeliminationand/orinactivationofvirusesandTSEagents.ThispartofISO22442doesnotcovertheutilizationofhumantissuesinmedicaldevices.ThispartofISO22442doesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.NOTE3ItisnotarequirementofthispartofISO22442tohaveafullqualitymanagementsystemduringmanufacture,butitdoesspecifyrequirementsforsomeoftheelementsofaqualitymanagementsystem.Attentionisdrawntothestandardsforqualitymanagementsystems(seeISO13485)thatcontrolallstagesofproductionorreprocessingofmedicaldevices.ThequalitymanagementsystemelementsthatarerequiredbythispartofISO22442canformapartofaqualitymanagementsystemconformingtoISO13485.NOTE4AgeneralprinciplefortheapplicationofISO22442isthatitisadvisabletogivedueconsiderationtotherequirementsandrecommendationscontainedinallthreepartsofthestandard.
【中国标准分类号】:C37
【国际标准分类号】:11_100_20
【页数】:24P.;A4
【正文语种】:英语
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