DIN EN ISO 22442-1-2008 医疗设备用动物组织及其衍生物.第1部分:风险管理的应用
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【英文标准名称】:Medicaldevicesutilizinganimaltissuesandtheirderivatives-Part1:Applicationofriskmanagement(ISO22442-1:2007);EnglishversionofDINENISO22442-1:2008-03
【原文标准名称】:医疗设备用动物组织及其衍生物.第1部分:风险管理的应用
【标准号】:DINENISO22442-1-2008
【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】:分析;动物产品;动物;应用;定义;衍生物;保健;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;保险业管理;安全;规范(验收);组织;使用
【英文主题词】:Analysis;Animalproducts;Animals;Applications;Definition;Definitions;Derivatives;Healthprotection;Impurities;Medicalproducts;Medicalsciences;Methods;Pathogenicbacteria;Procedures;Production;Risk;Riskanalysis;Riskmanagement;Safety;Specification(approval);Tissue;Use
【摘要】:ThispartofISO22442appliestomedicaldevicesotherthaninvitrodiagnosticmedicaldevicesmanufacturedutilizingmaterialsofanimalorigin,whicharenon-viableorhavebeenrenderednon-viable.Itspecifies,inconjunctionwithISO14971,aproceduretoidentifythehazardsandhazardoussituationsassociatedwithsuchdevices,toestimateandevaluatetheresultingrisks,tocontroltheserisks,andtomonitortheeffectivenessofthatcontrol.Furthermore,itoutlinesthedecisionprocessfortheresidualriskacceptability,takingintoaccountthebalanceofresidualrisk,asdefinedinISO14971,andexpectedmedicalbenefitascomparedtoavailablealternatives.ThispartofISO22442isintendedtoproviderequirementsandguidanceonriskmanagementrelatedtothehazardstypicalofmedicaldevicesmanufacturedutilizinganimaltissuesorderivativessuchas:a)contaminationbybacteria,mouldsoryeasts;b)contaminationbyviruses;c)contaminationbyagentscausingTransmissibleSpongiformEncephalopathies(TSE);d)materialresponsibleforundesiredpyrogenic,immunologicalortoxicologicalreactions.Forparasitesandotherunclassifiedpathogenicentities,similarprinciplescanapply.ThispartofISO22442doesnotstipulatelevelsofacceptabilitywhich,becausetheyaredeterminedbyamultiplicityoffactors,cannotbesetdowninsuchanInternationalStandardexceptforsomeparticularderivativesmentionedinAnnexC.AnnexCstipulateslevelsofTSEriskacceptabilityfortallowderivatives,animalcharcoal,milkandmilkderivatives,woolderivativesandaminoacids.ThispartofISO22442doesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.ThispartofISO22442doesnotcovertheutilizationofhumantissuesinmedicaldevices.NOTE1ItisnotarequirementofthispartofISO22442tohaveafullqualitymanagementsystemduringmanufacture.However,attentionisdrawntoInternationalStandardsforqualitymanagementsystems(seeISO13485)thatcontrolallstagesofproductionorreprocessingofmedicaldevices.NOTE2ForguidanceontheapplicationofthispartofISO22442seeAnnexA.
【中国标准分类号】:C37
【国际标准分类号】:11_100_99
【页数】:35P.;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1部分:风险管理的应用
【标准号】:DINENISO22442-1-2008
【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】:分析;动物产品;动物;应用;定义;衍生物;保健;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;保险业管理;安全;规范(验收);组织;使用
【英文主题词】:Analysis;Animalproducts;Animals;Applications;Definition;Definitions;Derivatives;Healthprotection;Impurities;Medicalproducts;Medicalsciences;Methods;Pathogenicbacteria;Procedures;Production;Risk;Riskanalysis;Riskmanagement;Safety;Specification(approval);Tissue;Use
【摘要】:ThispartofISO22442appliestomedicaldevicesotherthaninvitrodiagnosticmedicaldevicesmanufacturedutilizingmaterialsofanimalorigin,whicharenon-viableorhavebeenrenderednon-viable.Itspecifies,inconjunctionwithISO14971,aproceduretoidentifythehazardsandhazardoussituationsassociatedwithsuchdevices,toestimateandevaluatetheresultingrisks,tocontroltheserisks,andtomonitortheeffectivenessofthatcontrol.Furthermore,itoutlinesthedecisionprocessfortheresidualriskacceptability,takingintoaccountthebalanceofresidualrisk,asdefinedinISO14971,andexpectedmedicalbenefitascomparedtoavailablealternatives.ThispartofISO22442isintendedtoproviderequirementsandguidanceonriskmanagementrelatedtothehazardstypicalofmedicaldevicesmanufacturedutilizinganimaltissuesorderivativessuchas:a)contaminationbybacteria,mouldsoryeasts;b)contaminationbyviruses;c)contaminationbyagentscausingTransmissibleSpongiformEncephalopathies(TSE);d)materialresponsibleforundesiredpyrogenic,immunologicalortoxicologicalreactions.Forparasitesandotherunclassifiedpathogenicentities,similarprinciplescanapply.ThispartofISO22442doesnotstipulatelevelsofacceptabilitywhich,becausetheyaredeterminedbyamultiplicityoffactors,cannotbesetdowninsuchanInternationalStandardexceptforsomeparticularderivativesmentionedinAnnexC.AnnexCstipulateslevelsofTSEriskacceptabilityfortallowderivatives,animalcharcoal,milkandmilkderivatives,woolderivativesandaminoacids.ThispartofISO22442doesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.ThispartofISO22442doesnotcovertheutilizationofhumantissuesinmedicaldevices.NOTE1ItisnotarequirementofthispartofISO22442tohaveafullqualitymanagementsystemduringmanufacture.However,attentionisdrawntoInternationalStandardsforqualitymanagementsystems(seeISO13485)thatcontrolallstagesofproductionorreprocessingofmedicaldevices.NOTE2ForguidanceontheapplicationofthispartofISO22442seeAnnexA.
【中国标准分类号】:C37
【国际标准分类号】:11_100_99
【页数】:35P.;A4
【正文语种】:英语
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