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【英文标准名称】:Animaltissuesandtheirderivativesutilizedinthemanufactureofmedicaldevices-Validationoftheeliminationand/orinactivationofvirusesandtransmissibleagents
【原文标准名称】:医疗设备生产专用动物产品及其衍生物.病毒和传染性试剂消除和/或僵化的验证
【标准号】:BSEN12442-3-2000
【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】:医疗设备;验证;灭菌;病毒;研究;动物产品;医学科学;微生物分析;技术文献;动物;生物危害;微生物学;动物病毒
【英文主题词】:
【摘要】:1ThisPartofEN12442specifiesrequirementsforthevalidationofeliminationand/orinactivationofvirusesand/ortransmissibleagentsduringthemanufactureofmedicaldevices(excludingin-vitrodiagnosticmedicaldevices)utilizingmaterialsofanimalorigin.Itisnotapplicabletobacteria,mouldsandyeasts.NOTE1:Analysisandmanagementofriskandconventionalprocessesusedforsterilization,whenusedforthetreatmentofanimaltissuesformedicaldevices,havenotbeenshowntobecompletelyeffectiveininactivatingthecausativeagentsofspongiformencephalopathies.Selectivesourcingisextremelyimportant(seeEN12442-1andEN12442-2).NOTE2:EN550,EN552,EN554,ISO14160andEN1174mayberelevantforbacteria,mouldsandyeast(seeBibliography).2ThisPartofEN12442doesnotcovertheutilizationofhumantissuesinmedicaldevices.3ThisPartofEN12442doesnotdescribeaqualityassurancesystemforthecontrolofallstagesofmanufacture.NOTE:Attentionisdrawntothestandardsforqualitysystems(e.g.ENISO9001andEN46001orENISO9002andEN46002,seeBibliography)whichmaybeusedtocontrolallstagesofmanufacture.Itisnotarequirementofthisstandardtoapplyacompletequalitysystemduringmanufacturebutcertainelementsofsuchasystemarerequiredandtheseareaddressedatappropriateplacesinthetext.4ThisPartofEN12442doesnotconsidertheeffectofanymethodofeliminationand/orinactivationonthesuitabilityofthemedicaldeviceforitsintendeduse.
【中国标准分类号】:C30
【国际标准分类号】:11_120_01
【页数】:30P;A4
【正文语种】:英语