ISO 11140-1-2005 保健产品的灭菌.化学指示剂.第1部分:一般要求
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【英文标准名称】:Sterilizationofhealthcareproducts-Chemicalindicators-Part1:Generalrequirements
【原文标准名称】:保健产品的灭菌.化学指示剂.第1部分:一般要求
【标准号】:ISO11140-1-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:示踪法;甲醛;蒸汽灭菌器;干热;蒸汽灭菌;医疗产品;环氧乙烷;光线疗法;指示器;热处理;性能要求;热学;定义;化学指示剂;保健;非生物;灭菌;文字书写;包装件;规范(验收);试验;电离辐射;进程;储存期限;监督(认可);分类系统;医疗技术学;灭菌器;设备;医学科学
【英文主题词】:Biologicalhazards;Chemicalindicators;Classes;Classification;Classificationsystems;Definitions;Disposables;Dryheat;Dryness;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】:ThispartofISO11140specifiesgeneralrequirementsandtestmethodsforindicatorsthatshowexposuretosterilizationprocessesbymeansofphysicaland/orchemicalchangeofsubstances,andwhichareusedtomonitortheattainmentofoneormoreofthevariablesrequiredforasterilizationprocess.Theyarenotdependentfortheiractiononthepresenceorabsenceofalivingorganism.NOTEBiologicaltestsystemsareregardedasthosetestswhicharedependentfortheirinterpretationonthedemonstrationoftheviabilityofanorganism.TestsystemsofthistypeareconsideredintheISO11138seriesforbiologicalindicators(BIs).TherequirementsandtestmethodsofthispartofISO11140applytoallindicatorsspecifiedinsubsequentpartsofISO11140,unlesstherequirementismodifiedoraddedtobyasubsequentpart,inwhichcasetherequirementofthatparticularpartwillapply.RelevanttestequipmentisdescribedinISO18472.NOTEAdditionalrequirementsforspecifictestindicators(Class2indicators)aregiveninISO11140-3,ISO11140-4andISO11140-5.
【中国标准分类号】:C50
【国际标准分类号】:11_080_01;11_080_20
【页数】:27P;A4
【正文语种】:英语
【原文标准名称】:保健产品的灭菌.化学指示剂.第1部分:一般要求
【标准号】:ISO11140-1-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:示踪法;甲醛;蒸汽灭菌器;干热;蒸汽灭菌;医疗产品;环氧乙烷;光线疗法;指示器;热处理;性能要求;热学;定义;化学指示剂;保健;非生物;灭菌;文字书写;包装件;规范(验收);试验;电离辐射;进程;储存期限;监督(认可);分类系统;医疗技术学;灭菌器;设备;医学科学
【英文主题词】:Biologicalhazards;Chemicalindicators;Classes;Classification;Classificationsystems;Definitions;Disposables;Dryheat;Dryness;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】:ThispartofISO11140specifiesgeneralrequirementsandtestmethodsforindicatorsthatshowexposuretosterilizationprocessesbymeansofphysicaland/orchemicalchangeofsubstances,andwhichareusedtomonitortheattainmentofoneormoreofthevariablesrequiredforasterilizationprocess.Theyarenotdependentfortheiractiononthepresenceorabsenceofalivingorganism.NOTEBiologicaltestsystemsareregardedasthosetestswhicharedependentfortheirinterpretationonthedemonstrationoftheviabilityofanorganism.TestsystemsofthistypeareconsideredintheISO11138seriesforbiologicalindicators(BIs).TherequirementsandtestmethodsofthispartofISO11140applytoallindicatorsspecifiedinsubsequentpartsofISO11140,unlesstherequirementismodifiedoraddedtobyasubsequentpart,inwhichcasetherequirementofthatparticularpartwillapply.RelevanttestequipmentisdescribedinISO18472.NOTEAdditionalrequirementsforspecifictestindicators(Class2indicators)aregiveninISO11140-3,ISO11140-4andISO11140-5.
【中国标准分类号】:C50
【国际标准分类号】:11_080_01;11_080_20
【页数】:27P;A4
【正文语种】:英语
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