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【英文标准名称】:Animaltissuesandtheirderivativesutilizedinthemanufactureofmedicaldevices-Controlsonsourcing,collectionandhandling
【原文标准名称】:医疗设备生产专用动物产品及其衍生物.来源控制,采集和处理
【标准号】:BSEN12442-2-2000
【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】:动物;医学科学;检验;储存;动物产品;环境卫生;细胞;反刍动物;医疗设备;验收(鉴定)
【英文主题词】:
【摘要】:1ThisPartofEN12442specifiesrequirementsforcontrolsonthesourcing,collectionandhandling(whichincludesstorageandtransport)ofanimalsandtissuesforthemanufactureofmedicaldevicesutilizingmaterialsofanimaloriginotherthaninvitrodiagnosticmedicaldevices.NOTE1:RequirementsfortheriskanalysisoftheuseofmaterialsofanimalorigininmedicaldevicesaredescribedinEN12442-1.NOTE2:Conventionalprocessesusedforsterilization,whenusedforthetreatmentofanimaltissuesformedicaldevices,havenotbeenshowntobecompletelyeffectiveininactivatingthecausativeagentsofspongiformencephalopathies.Selectivesourcingisthusextremelyimportant.ManufacturersshouldrefertoEN12442-3forinformationonthevalidationoftheeliminationand/orinactivationofvirusesandtransmissibleagents.2ThisPartofEN12442doesnotcovertheutilizationofhumantissuesinmedicaldevices.3ThisPartofEN12442doesnotdescribeaqualityassurancesystemforthecontrolofallstagesofmanufacture.NOTE:Attentionisdrawntothestandardsforqualitysystems(seeENISO9001andEN46001orENISO9002andEN46002)whichrelatetoallstagesofmanufacture.Itisnotarequirementofthisstandardtohaveacompletequalitysystemduringmanufacturebutcertainelementsofsuchasystemarerequired.4ThisPartofEN12442doesnotconsidertheeffectofanymethodofeliminationand/orinactivationonthesuitabilityofthemedicaldeviceforitsintendeduse.
【中国标准分类号】:C30
【国际标准分类号】:11_120_01
【页数】:20P;A4
【正文语种】:英语