DIN EN ISO 15883-1-2009 清洗消毒器.第1部分:一般要求,术语,定义和试验(ISO15883-1-2006).英文版本DINENISO15883-1-2009-09
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【英文标准名称】:Washer-disinfectors-Part1:Generalrequirements,termsanddefinitionsandtests(ISO15883-1:2006);EnglishversionofDINENISO15883-1:2009-09
【原文标准名称】:清洗消毒器.第1部分:一般要求,术语,定义和试验(ISO15883-1-2006).英文版本DINENISO15883-1-2009-09
【标准号】:DINENISO15883-1-2009
【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】:清洁设备;清洁机;控制装置;控制设备;去污染;定义(术语);消毒设备;消毒器;电气器具;电气工程;英语;一般条件;实验室器具;实验室器皿;测量仪器;医疗器械;医疗器材;性能要求;压力容器;安全性;安全规则;安全性要求;规范(验收);测试
【英文主题词】:Cleaningequipment;Cleaningmachines;Controldevices;Controlequipment;Decontaminations;Definitions;Disinfectionapparatus;Disinfectors;Electricappliances;Electricalengineering;Englishlanguage;Generalconditions;Laboratoryapparatus;Laboratoryware;Measuringinstruments;Medicaldevices;Medicalequipment;Performancerequirements;Pressurevessels;Safety;Safetyregulations;Safetyrequirements;Specification(approval);Testing
【摘要】:ThispartofISO15883specifiesgeneralperformancerequirementsforwasher-disinfectors(WD)andtheiraccessoriesthatareintendedtobeusedforcleaninganddisinfectionofre-usablemedicaldevicesandotherarticlesusedinthecontextofmedical,dental,pharmaceuticalandveterinarypractice.Itspecifiesperformancerequirementsforcleaninganddisinfectionaswellasfortheaccessorieswhichcanberequiredtoachievethenecessaryperformance.Themethodsandinstrumentationrequiredforvalidation,routinecontrolandmonitoringandre-validation,periodicallyandafteressentialrepairs,arealsospecified.Therequirementsforwasher-disinfectorsintendedtoprocessspecificloadsarespecifiedinsubsequentpartsofthisstandard.Forwasher-disinfectorsintendedtoprocessloadsoftwoormoredifferenttypestherequirementsofallrelevantpartsofthisstandardapply.ThispartofISO15883doesnotspecifyrequirementsintendedformachinesforuseforlaundryorgeneralcateringpurposes.ThispartofISO15883doesnotincluderequirementsformachineswhichareintendedtosterilizetheloadorwhicharedesignatedas"sterilizers",thesearespecifiedinotherstandardseg.EN285.Thespecifiedperformancerequirementsofthisstandardmaynotensuretheinactivationorremovalofthecausativeagent(s)(prionprotein)oftransmissiblespongiformencephalopathies.NOTEIfitisconsideredthatprionproteincanbepresent,particularcareisneededinthechoiceofdisinfectantsandcleaningagentstoensurethatthechemicalsuseddonotreactwiththeprionproteininamannerthatmayinhibititsremovalorinactivation.ThispartofISO15883maybeusedbyprospectivepurchasersandmanufacturersasthebasisofagreementonthespecificationofaWD.ThetestmethodsfordemonstrationofcompliancewiththerequirementsofthispartofISO15883mayalsobeemployedbyuserstodemonstratecontinuedcomplianceoftheinstalledWDthroughoutitsworkinglife.GuidanceonaroutinetestprogrammeisgiveninAnnexA.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:84P.;A4
【正文语种】:英语
【原文标准名称】:清洗消毒器.第1部分:一般要求,术语,定义和试验(ISO15883-1-2006).英文版本DINENISO15883-1-2009-09
【标准号】:DINENISO15883-1-2009
【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】:清洁设备;清洁机;控制装置;控制设备;去污染;定义(术语);消毒设备;消毒器;电气器具;电气工程;英语;一般条件;实验室器具;实验室器皿;测量仪器;医疗器械;医疗器材;性能要求;压力容器;安全性;安全规则;安全性要求;规范(验收);测试
【英文主题词】:Cleaningequipment;Cleaningmachines;Controldevices;Controlequipment;Decontaminations;Definitions;Disinfectionapparatus;Disinfectors;Electricappliances;Electricalengineering;Englishlanguage;Generalconditions;Laboratoryapparatus;Laboratoryware;Measuringinstruments;Medicaldevices;Medicalequipment;Performancerequirements;Pressurevessels;Safety;Safetyregulations;Safetyrequirements;Specification(approval);Testing
【摘要】:ThispartofISO15883specifiesgeneralperformancerequirementsforwasher-disinfectors(WD)andtheiraccessoriesthatareintendedtobeusedforcleaninganddisinfectionofre-usablemedicaldevicesandotherarticlesusedinthecontextofmedical,dental,pharmaceuticalandveterinarypractice.Itspecifiesperformancerequirementsforcleaninganddisinfectionaswellasfortheaccessorieswhichcanberequiredtoachievethenecessaryperformance.Themethodsandinstrumentationrequiredforvalidation,routinecontrolandmonitoringandre-validation,periodicallyandafteressentialrepairs,arealsospecified.Therequirementsforwasher-disinfectorsintendedtoprocessspecificloadsarespecifiedinsubsequentpartsofthisstandard.Forwasher-disinfectorsintendedtoprocessloadsoftwoormoredifferenttypestherequirementsofallrelevantpartsofthisstandardapply.ThispartofISO15883doesnotspecifyrequirementsintendedformachinesforuseforlaundryorgeneralcateringpurposes.ThispartofISO15883doesnotincluderequirementsformachineswhichareintendedtosterilizetheloadorwhicharedesignatedas"sterilizers",thesearespecifiedinotherstandardseg.EN285.Thespecifiedperformancerequirementsofthisstandardmaynotensuretheinactivationorremovalofthecausativeagent(s)(prionprotein)oftransmissiblespongiformencephalopathies.NOTEIfitisconsideredthatprionproteincanbepresent,particularcareisneededinthechoiceofdisinfectantsandcleaningagentstoensurethatthechemicalsuseddonotreactwiththeprionproteininamannerthatmayinhibititsremovalorinactivation.ThispartofISO15883maybeusedbyprospectivepurchasersandmanufacturersasthebasisofagreementonthespecificationofaWD.ThetestmethodsfordemonstrationofcompliancewiththerequirementsofthispartofISO15883mayalsobeemployedbyuserstodemonstratecontinuedcomplianceoftheinstalledWDthroughoutitsworkinglife.GuidanceonaroutinetestprogrammeisgiveninAnnexA.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:84P.;A4
【正文语种】:英语
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