【英文标准名称】:Sterilizationofhealthcareproducts-Chemicalindicators-Generalrequirements
【原文标准名称】:保健产品的消毒.化学指示剂.一般要求
【标准号】:BSENISO11140-1-2005
【标准状态】:作废
【国别】:英国
【发布日期】:2006-02-22
【实施或试行日期】:2006-02-22
【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】:化学指示剂;分类;分类系统;定义;干热;设备;环氧乙烷;甲醛;保健;热学;热处理;指示器;电离辐射;文字书写;医疗产品;医学科学;医疗技术学;非生物学的;包装件;性能要求;光线疗法;过程;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);试验;示踪法
【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】:ISO11140-1:2005specifiesgeneralrequirementsandtestmethodsforindicatorsthatshowexposuretosterilizationprocessesbymeansofphysicaland/orchemicalchangeofsubstances,andwhichareusedtomonitortheattainmentofoneormoreofthevariablesrequiredforasterilizationprocess.Theyarenotdependentfortheiractiononthepresenceorabsenceofalivingorganism.TherequirementsandtestmethodsofISO11140-1:2005applytoallindicatorsspecifiedinsubsequentpartsofISO11140,unlesstherequirementismodifiedoraddedtobyasubsequentpart,inwhichcasetherequirementofthatparticularpartwillapply.
【中国标准分类号】:C47;C04
【国际标准分类号】:11_080_20
【页数】:40P.;A4
【正文语种】:英语