BS EN 12442-1-2000 医疗设备生产专用动物产品及其衍生物.风险分析和管理
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【英文标准名称】:Animaltissuesandtheirderivativesutilizedinthemanufactureofmedicaldevices-Analysisandmanagementofrisk
【原文标准名称】:医疗设备生产专用动物产品及其衍生物.风险分析和管理
【标准号】:BSEN12442-1-2000
【标准状态】:作废
【国别】:英国
【发布日期】:2000-11-15
【实施或试行日期】:2000-11-15
【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】:危害;医疗设备;动物产品;管理;生物危害;医学科学;动物
【英文主题词】:Analysis;Animalproducts;Animals;Definition;Definitions;Derivatives;Impurities;Medicalproducts;Medicalsciences;Methods;Pathogenicbacteria;Procedures;Production;Risk;Riskanalysis;Use
【摘要】:1ThisPartofEN12442appliestomedicaldevices(excludingin-vitrodiagnosticmedicaldevices)manufacturedutilizinganimaltissueorproductsderivedfromanimaltissue,whicharenon-viableorhavebeenrenderednon-viable.Itspecifies,inconjunctionwithEN1441,aproceduretoinvestigate,usingavailableinformation,thesafetyofsuchdevicesbyidentifyinghazardsandestimatingtherisksassociatedwiththedevice(riskanalysis).2ThisPartofEN12442isintendedtoproviderequirementsandguidanceonriskanalysisrelatedtothetypicalhazardsofmedicaldevicesmanufacturedutilizinganimaltissuesorderivativessuchasa)contaminationbybacteria,mouldsoryeasts;b)contaminationbyvirusesortransmissibleagentssuchaspathogenicentities,oragentscausingspongiformencephalopathies,prionsandsimilarentities(e.g.BSE,scrapie);c)undesiredpyrogenic,immunologicalortoxicologicalreactions.3ThisPartofEN12442doesnotstipulatelevelsofacceptabilitywhich,becausetheyaredeterminedbyamultiplicityoffactors,cannotbesetdowninsuchastandard.4Inaddition,thisPartofEN12442isintendedtoproviderequirementsandguidanceonriskmanagement.5ThisPartofEN12442doesnotcovertheutilizationofhumantissuesinmedicaldevices.NOTE:Therearematerialswhichdonotfallunderthescopeofthisstandardbecausethesearenotderivedfromanimals.Inthisstandardaspecificdefinitionofanimalhasbeengiven.6ThisPartofEN12442doesnotdescribeaqualityassurancesystemforthecontrolofallstagesofmanufacture.NOTE:Attentionisdrawntothestandardsforqualitysystems(seeENISO9001andEN46001orENISO9002andEN46002)whichrelatetoallstagesofmanufacture.Itisnotarequirementofthisstandardtohaveacompletequalitysystemduringmanufacturebutcertainelementsofsuchasystemarerequired.7TheprinciplesofthisPartofEN12442mayalsobeappliedbyanalogytomedicaldevicesmanufacturedutilizingmaterialderivedfromanon-vertebrateorganism,incaseswheretherisksaddressedinthisstandardarerelevant.
【中国标准分类号】:C30
【国际标准分类号】:11_120_01
【页数】:24P;A4
【正文语种】:英语
【原文标准名称】:医疗设备生产专用动物产品及其衍生物.风险分析和管理
【标准号】:BSEN12442-1-2000
【标准状态】:作废
【国别】:英国
【发布日期】:2000-11-15
【实施或试行日期】:2000-11-15
【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】:危害;医疗设备;动物产品;管理;生物危害;医学科学;动物
【英文主题词】:Analysis;Animalproducts;Animals;Definition;Definitions;Derivatives;Impurities;Medicalproducts;Medicalsciences;Methods;Pathogenicbacteria;Procedures;Production;Risk;Riskanalysis;Use
【摘要】:1ThisPartofEN12442appliestomedicaldevices(excludingin-vitrodiagnosticmedicaldevices)manufacturedutilizinganimaltissueorproductsderivedfromanimaltissue,whicharenon-viableorhavebeenrenderednon-viable.Itspecifies,inconjunctionwithEN1441,aproceduretoinvestigate,usingavailableinformation,thesafetyofsuchdevicesbyidentifyinghazardsandestimatingtherisksassociatedwiththedevice(riskanalysis).2ThisPartofEN12442isintendedtoproviderequirementsandguidanceonriskanalysisrelatedtothetypicalhazardsofmedicaldevicesmanufacturedutilizinganimaltissuesorderivativessuchasa)contaminationbybacteria,mouldsoryeasts;b)contaminationbyvirusesortransmissibleagentssuchaspathogenicentities,oragentscausingspongiformencephalopathies,prionsandsimilarentities(e.g.BSE,scrapie);c)undesiredpyrogenic,immunologicalortoxicologicalreactions.3ThisPartofEN12442doesnotstipulatelevelsofacceptabilitywhich,becausetheyaredeterminedbyamultiplicityoffactors,cannotbesetdowninsuchastandard.4Inaddition,thisPartofEN12442isintendedtoproviderequirementsandguidanceonriskmanagement.5ThisPartofEN12442doesnotcovertheutilizationofhumantissuesinmedicaldevices.NOTE:Therearematerialswhichdonotfallunderthescopeofthisstandardbecausethesearenotderivedfromanimals.Inthisstandardaspecificdefinitionofanimalhasbeengiven.6ThisPartofEN12442doesnotdescribeaqualityassurancesystemforthecontrolofallstagesofmanufacture.NOTE:Attentionisdrawntothestandardsforqualitysystems(seeENISO9001andEN46001orENISO9002andEN46002)whichrelatetoallstagesofmanufacture.Itisnotarequirementofthisstandardtohaveacompletequalitysystemduringmanufacturebutcertainelementsofsuchasystemarerequired.7TheprinciplesofthisPartofEN12442mayalsobeappliedbyanalogytomedicaldevicesmanufacturedutilizingmaterialderivedfromanon-vertebrateorganism,incaseswheretherisksaddressedinthisstandardarerelevant.
【中国标准分类号】:C30
【国际标准分类号】:11_120_01
【页数】:24P;A4
【正文语种】:英语
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