DIN EN ISO 15883-4-2009 清洗消毒器.第4部分:不耐热的内窥镜使用化学消毒的清洗消毒器的试验和要求(ISO15883-4-2008).英文版本DINENISO15883-4-2009-09
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【英文标准名称】:Washer-disinfectors-Part4:Requirementsandtestsforwasher-disinfectorsemployingchemicaldisinfectionforthermolabileendoscopes(ISO15883-4:2008);EnglishversionofDINENISO15883-4:2009-09
【原文标准名称】:清洗消毒器.第4部分:不耐热的内窥镜使用化学消毒的清洗消毒器的试验和要求(ISO15883-4-2008).英文版本DINENISO15883-4-2009-09
【标准号】:DINENISO15883-4-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【实施或试行日期】:2009-09-01
【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】:化学清洗;清洗设备;清洁机;合格;控制装置;去污染;定义(术语);消毒设备;消毒器;效率;内窥镜仪器;英语;医疗器械;医疗器材;医学科学;性能;安全性;安全规则;安全性要求;测试
【英文主题词】:Chemicalcleaning;Cleaningequipment;Cleaningmachines;Conformity;Controldevices;Decontaminations;Definitions;Disinfectionapparatus;Disinfectors;Efficiency;Endoscopicapparatus;Englishlanguage;Medicaldevices;Medicalequipment;Medicalsciences;Performance;Safety;Safetyregulations;Safetyrequirements;Testing
【摘要】:ThispartofISO15883specifiestheparticularrequirements,includingperformance,forwasher-disinfectors(WDs)thatareintendedtobeusedforcleaningandchemicaldisinfectionoftnermolabileendoscopes.ThispartofISO15883alsospecifiestheperformancerequirementsforthecleaninganddisinfectionofthewasher-disinfectoranditscomponentsandaccessorieswhichmayberequiredtoachievethenecessaryperformance.Themethods,instrumentationandinstructionsrequiredfortypetesting,workstesting,validation(installation,operationalandperformancequalificationonfirstinstallation),routinecontrolandmonitoringandre-validation.periodicallyandafteressentialrepairs,arealsospecified.NOTE1Inaddition,AnnexAgivesguidanceonanappropriatedivisionofresponsibilityfortherangeofactivitiescoveredbythispartofISO15883.NOTE2WDscomplyingwiththispartofISO15883canalsobeusedforcleaningandchemicaldisinfectionofotherthermolabilere-usablemedicaldevicesforwhichthedevicemanufacturerhasrecommendedthismethodofdisinfectionWDscomplyingwiththerequirementsofthispartofISO15883arenotintendedforcleaninganddisinfectionofmedicaldevices,includingendoscopicaccessories,whichareheatstableandcanbedisinfectedorsterilizedbythermalmethods(seeISO15883-1:2006,4.1.5).ThespecifiedperformancerequirementsofthispartofISO15883maynotensuretheinactivationorremovalofthecausativeagent(s)(prioriprotein)oftransmissiblespongiformencephalopathies.NOTE3Ifitisconsideredthatprioriproteinmightbepresent,particularcareisneededinthechoiceofdisinfectantsandcleaningagentstoensurethatthechemicalsuseddonotreactwiththeprionproteininamannerthatmayinhibititsremovalorinactivationfromtheloadorwasher-disinfector.ThispartofISO15883canbeusedbyprospectivepurchasersandmanufacturersasthebasisofagreementonthespecificationofWDmanufacturersofendoscopes,cleaningproducts,disinfectingproducts,andalsobyusers.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:61P.;A4
【正文语种】:英语
【原文标准名称】:清洗消毒器.第4部分:不耐热的内窥镜使用化学消毒的清洗消毒器的试验和要求(ISO15883-4-2008).英文版本DINENISO15883-4-2009-09
【标准号】:DINENISO15883-4-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【实施或试行日期】:2009-09-01
【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】:化学清洗;清洗设备;清洁机;合格;控制装置;去污染;定义(术语);消毒设备;消毒器;效率;内窥镜仪器;英语;医疗器械;医疗器材;医学科学;性能;安全性;安全规则;安全性要求;测试
【英文主题词】:Chemicalcleaning;Cleaningequipment;Cleaningmachines;Conformity;Controldevices;Decontaminations;Definitions;Disinfectionapparatus;Disinfectors;Efficiency;Endoscopicapparatus;Englishlanguage;Medicaldevices;Medicalequipment;Medicalsciences;Performance;Safety;Safetyregulations;Safetyrequirements;Testing
【摘要】:ThispartofISO15883specifiestheparticularrequirements,includingperformance,forwasher-disinfectors(WDs)thatareintendedtobeusedforcleaningandchemicaldisinfectionoftnermolabileendoscopes.ThispartofISO15883alsospecifiestheperformancerequirementsforthecleaninganddisinfectionofthewasher-disinfectoranditscomponentsandaccessorieswhichmayberequiredtoachievethenecessaryperformance.Themethods,instrumentationandinstructionsrequiredfortypetesting,workstesting,validation(installation,operationalandperformancequalificationonfirstinstallation),routinecontrolandmonitoringandre-validation.periodicallyandafteressentialrepairs,arealsospecified.NOTE1Inaddition,AnnexAgivesguidanceonanappropriatedivisionofresponsibilityfortherangeofactivitiescoveredbythispartofISO15883.NOTE2WDscomplyingwiththispartofISO15883canalsobeusedforcleaningandchemicaldisinfectionofotherthermolabilere-usablemedicaldevicesforwhichthedevicemanufacturerhasrecommendedthismethodofdisinfectionWDscomplyingwiththerequirementsofthispartofISO15883arenotintendedforcleaninganddisinfectionofmedicaldevices,includingendoscopicaccessories,whichareheatstableandcanbedisinfectedorsterilizedbythermalmethods(seeISO15883-1:2006,4.1.5).ThespecifiedperformancerequirementsofthispartofISO15883maynotensuretheinactivationorremovalofthecausativeagent(s)(prioriprotein)oftransmissiblespongiformencephalopathies.NOTE3Ifitisconsideredthatprioriproteinmightbepresent,particularcareisneededinthechoiceofdisinfectantsandcleaningagentstoensurethatthechemicalsuseddonotreactwiththeprionproteininamannerthatmayinhibititsremovalorinactivationfromtheloadorwasher-disinfector.ThispartofISO15883canbeusedbyprospectivepurchasersandmanufacturersasthebasisofagreementonthespecificationofWDmanufacturersofendoscopes,cleaningproducts,disinfectingproducts,andalsobyusers.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:61P.;A4
【正文语种】:英语
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