DIN EN ISO 11140-1-2009 保健产品的消毒.化学指示剂.第1部分:一般要求(ISO11140-1-2005).英文版本DINENISO11140-1-2009-09
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【英文标准名称】:Sterilizationofhealthcareproducts-Chemicalindicators-Part1:Generalrequirements(ISO11140-1:2005);EnglishversionofDINENISO11140-1:2009-09
【原文标准名称】:保健产品的消毒.化学指示剂.第1部分:一般要求(ISO11140-1-2005).英文版本DINENISO11140-1-2009-09
【标准号】:DINENISO11140-1-2009
【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】:生物危害;化学指示剂;等级;分类;分类系统;定义(术语);一次性用品;干热;干燥度;英语;设备;环氧乙烷;甲醛;保健;热学;热处理;指示器;使用说明书;离子化;电离辐射;文字书写;作标记;道路标记;医疗器械;医疗产品;医学科学;医疗技术学;非生物的;包装件;性能;性能要求;光线疗法;过程;辐射;储存期限;规范;规范(验收);蒸汽灭菌;蒸汽灭菌器;灭菌;灭菌器;监督(认可);系统;测试;示踪法;使用;蒸气
【英文主题词】:Biologicalhazards;Chemicalindicators;Classes;Classification;Classificationsystems;Definitions;Disposables;Dryheat;Dryness;Englishlanguage;Equipment;Ethyleneoxide;Formaldehyde;Healthprotection;Heat;Heattreatment;Indicators;Instructionsforuse;Ionizing;Ionizingradiation;Letterings;Marking;Markingofroads;Medicaldevices;Medicalproducts;Medicalsciences;Medicaltechnology;Non-biological;Packages;Performance;Performancerequirements;Phototherapy;Process;Radiation;Shelflife;Specification;Specification(approval);Steamsterilization;Steamsterilizers;Sterilization(hygiene);Sterilizers;Surveillance(approval);Systems;Testing;Tracermethods;Use;Vapours
【摘要】:1.1ThispartofISO11140specifiesgeneralrequirementsandtestmethodsforindicatorsthatshowexposuretosterilizationprocessesbymeansofphysicaland/orchemicalchangeofsubstances,andwhichareusedtomonitortheattainmentofoneormoreofthevariablesrequiredforasterilizationprocess.Theyarenotdependentfortheiractiononthepresenceorabsenceofalivingorganism.NOTEBiologicaltestsystemsareregardedasthosetestswhicharedependentfortheirinterpretationonthedemonstrationoftheviabilityofanorganism.TestsystemsofthistypeareconsideredintheISO11138sedesforbiologicalindicators(BIs).1.2TherequirementsandtestmethodsofthispartofISO11140applytoallindicatorsspecifiedinsubsequentpartsofISO11140,unlesstherequirementismodifiedoraddedtobyasubsequentpart,inwhichcasetherequirementofthatparticularpartwillapply.RelevanttestequipmentisdescribedinISO18472.NOTEAdditionalrequirementsforspecifictestindicators(Class2indicators)aregiveninISO11140-3,ISO11140-4andISO11140-5.
【中国标准分类号】:C05
【国际标准分类号】:11_080_20
【页数】:36P.;A4
【正文语种】:英语
【原文标准名称】:保健产品的消毒.化学指示剂.第1部分:一般要求(ISO11140-1-2005).英文版本DINENISO11140-1-2009-09
【标准号】:DINENISO11140-1-2009
【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】:生物危害;化学指示剂;等级;分类;分类系统;定义(术语);一次性用品;干热;干燥度;英语;设备;环氧乙烷;甲醛;保健;热学;热处理;指示器;使用说明书;离子化;电离辐射;文字书写;作标记;道路标记;医疗器械;医疗产品;医学科学;医疗技术学;非生物的;包装件;性能;性能要求;光线疗法;过程;辐射;储存期限;规范;规范(验收);蒸汽灭菌;蒸汽灭菌器;灭菌;灭菌器;监督(认可);系统;测试;示踪法;使用;蒸气
【英文主题词】:Biologicalhazards;Chemicalindicators;Classes;Classification;Classificationsystems;Definitions;Disposables;Dryheat;Dryness;Englishlanguage;Equipment;Ethyleneoxide;Formaldehyde;Healthprotection;Heat;Heattreatment;Indicators;Instructionsforuse;Ionizing;Ionizingradiation;Letterings;Marking;Markingofroads;Medicaldevices;Medicalproducts;Medicalsciences;Medicaltechnology;Non-biological;Packages;Performance;Performancerequirements;Phototherapy;Process;Radiation;Shelflife;Specification;Specification(approval);Steamsterilization;Steamsterilizers;Sterilization(hygiene);Sterilizers;Surveillance(approval);Systems;Testing;Tracermethods;Use;Vapours
【摘要】:1.1ThispartofISO11140specifiesgeneralrequirementsandtestmethodsforindicatorsthatshowexposuretosterilizationprocessesbymeansofphysicaland/orchemicalchangeofsubstances,andwhichareusedtomonitortheattainmentofoneormoreofthevariablesrequiredforasterilizationprocess.Theyarenotdependentfortheiractiononthepresenceorabsenceofalivingorganism.NOTEBiologicaltestsystemsareregardedasthosetestswhicharedependentfortheirinterpretationonthedemonstrationoftheviabilityofanorganism.TestsystemsofthistypeareconsideredintheISO11138sedesforbiologicalindicators(BIs).1.2TherequirementsandtestmethodsofthispartofISO11140applytoallindicatorsspecifiedinsubsequentpartsofISO11140,unlesstherequirementismodifiedoraddedtobyasubsequentpart,inwhichcasetherequirementofthatparticularpartwillapply.RelevanttestequipmentisdescribedinISO18472.NOTEAdditionalrequirementsforspecifictestindicators(Class2indicators)aregiveninISO11140-3,ISO11140-4andISO11140-5.
【中国标准分类号】:C05
【国际标准分类号】:11_080_20
【页数】:36P.;A4
【正文语种】:英语
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