BS EN ISO 14160-1998 包含有动物来源材料的一次性医用设备的消毒.液体化学消毒液消毒的确认和常规管理
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【英文标准名称】:Sterilizationofsingle-usemedicaldevicesincorporatingmaterialsofanimalorigin-Validationandroutinecontrolofsterilizationbyliquidchemicalsterilants
【原文标准名称】:包含有动物来源材料的一次性医用设备的消毒.液体化学消毒液消毒的确认和常规管理
【标准号】:BSENISO14160-1998
【标准状态】:作废
【国别】:英国
【发布日期】:1998-06-15
【实施或试行日期】:1998-06-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:微生物;认证(认可);人员;液体;灭菌;性能;医疗设备;文献索引;维修;质量控制;微生物分析;可混用性;医疗器械;无菌设备;兼容性;动物产品;验证;可处置的
【英文主题词】:Animalproducts;Bacterialcount;Certification;Chemicals;Definition;Definitions;Disposable;Disposables;Equipmentforsingleuse;Germs;Liquidmaterials;Liquids;Medicalproducts;Sterileequipment;Sterilization(hygiene);Surveillance(approval);Validation
【摘要】:ThisInternationalStandardspecifiesrequirementsforthedevelopment,validation,processcontrolandmonitoringofthesterilization,bytheuseofliquidchemicalsterilants,ofsingle-usemedicaldevicescomprising,inwholeorinpart,materialsofanimalorigin.ThisInternationalStandarddoesnotapplytomaterialofhumanorigin.ThisInternationalStandarddoesnotdescribeaqualityassurancesystemforthecontrolofallstagesofmanufacture.NOTE1Attentionisdrawntothestandardsforqualitysystems(seeISO9001andISO13485orISO9002andISO13488)whichcanbeusedinthecontrolofallstagesofmanufactureincludingthesterilizationprocess.ThisInternationalStandarddoesnotdescribeteststoestablishtheeffectsofanychosensterilizationmethoduponthefitnessforuseofthemedicaldevice.NOTE2Suchtestingisacrucialpartofthedesignanddevelopmentofamedicaldevice.ThisInternationalStandarddoesnotdescribemethodsforthevalidationoftheinactivationofviruses.NOTE3Indevelopingamethodforprocessingmedicaldevicescontainingmaterialsofanimalorigin,considerationoftheeffectsofliquidchemicalsterilizationonpotentialviralcontaminantswillalsobenecessarybecauseofthesourceofmaterialsusedinthemanufactureoftheseparticularmedicaldevices.TheimportanceofvalidationofviralinactivationforprocesseswithinthescopeofthisInternationalStandardisrecognized.ThisaspectisexcludedfromthisInternationalStandard;aseparateEuropeanStandardisinpreparation(EN12442-3).NOTE4Liquidchemicalsterilantstraditionallyemployedtosterilizeanimaltissuesinmedicaldevicesmaynotbeeffectiveininactivatingthecausativeagentsoftransmissablespongiformencephalopathiessuchasbovinespongiformencephalopathy(BSE),orscrapie.SatisfactoryvalidationinaccordancewiththisInternationalStandardshouldnotbeassumedtodemonstrateinactivationofinfectiveagentsofthistype.ThisInternationalStandarddoesnotcoverthelevelofresidualsterilantwithinmedicaldevices.NOTE5ISO14538isconcernedwiththisissue.
【中国标准分类号】:C05
【国际标准分类号】:11_080_20
【页数】:34P;A4
【正文语种】:英语
【原文标准名称】:包含有动物来源材料的一次性医用设备的消毒.液体化学消毒液消毒的确认和常规管理
【标准号】:BSENISO14160-1998
【标准状态】:作废
【国别】:英国
【发布日期】:1998-06-15
【实施或试行日期】:1998-06-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:微生物;认证(认可);人员;液体;灭菌;性能;医疗设备;文献索引;维修;质量控制;微生物分析;可混用性;医疗器械;无菌设备;兼容性;动物产品;验证;可处置的
【英文主题词】:Animalproducts;Bacterialcount;Certification;Chemicals;Definition;Definitions;Disposable;Disposables;Equipmentforsingleuse;Germs;Liquidmaterials;Liquids;Medicalproducts;Sterileequipment;Sterilization(hygiene);Surveillance(approval);Validation
【摘要】:ThisInternationalStandardspecifiesrequirementsforthedevelopment,validation,processcontrolandmonitoringofthesterilization,bytheuseofliquidchemicalsterilants,ofsingle-usemedicaldevicescomprising,inwholeorinpart,materialsofanimalorigin.ThisInternationalStandarddoesnotapplytomaterialofhumanorigin.ThisInternationalStandarddoesnotdescribeaqualityassurancesystemforthecontrolofallstagesofmanufacture.NOTE1Attentionisdrawntothestandardsforqualitysystems(seeISO9001andISO13485orISO9002andISO13488)whichcanbeusedinthecontrolofallstagesofmanufactureincludingthesterilizationprocess.ThisInternationalStandarddoesnotdescribeteststoestablishtheeffectsofanychosensterilizationmethoduponthefitnessforuseofthemedicaldevice.NOTE2Suchtestingisacrucialpartofthedesignanddevelopmentofamedicaldevice.ThisInternationalStandarddoesnotdescribemethodsforthevalidationoftheinactivationofviruses.NOTE3Indevelopingamethodforprocessingmedicaldevicescontainingmaterialsofanimalorigin,considerationoftheeffectsofliquidchemicalsterilizationonpotentialviralcontaminantswillalsobenecessarybecauseofthesourceofmaterialsusedinthemanufactureoftheseparticularmedicaldevices.TheimportanceofvalidationofviralinactivationforprocesseswithinthescopeofthisInternationalStandardisrecognized.ThisaspectisexcludedfromthisInternationalStandard;aseparateEuropeanStandardisinpreparation(EN12442-3).NOTE4Liquidchemicalsterilantstraditionallyemployedtosterilizeanimaltissuesinmedicaldevicesmaynotbeeffectiveininactivatingthecausativeagentsoftransmissablespongiformencephalopathiessuchasbovinespongiformencephalopathy(BSE),orscrapie.SatisfactoryvalidationinaccordancewiththisInternationalStandardshouldnotbeassumedtodemonstrateinactivationofinfectiveagentsofthistype.ThisInternationalStandarddoesnotcoverthelevelofresidualsterilantwithinmedicaldevices.NOTE5ISO14538isconcernedwiththisissue.
【中国标准分类号】:C05
【国际标准分类号】:11_080_20
【页数】:34P;A4
【正文语种】:英语
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