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【英文标准名称】:Sterilizationofhealthcareproducts-Chemicalindicators-Part4:Class2indicatorsforsteampenetrationtestpacks
【原文标准名称】:保健品消毒化学指示物蒸汽穿透试验包装的2级指示物
【标准号】:ISO11140-4-2001
【标准状态】:作废
【国别】:国际
【发布日期】:2001-05
【实施或试行日期】:
【发布单位】:国际标准化组织(ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:灭菌;空气;蒸汽灭菌;保健;规范;医疗产品;包装件;蒸汽灭菌器;分类系统;示踪法;灭菌器;医学科学;指示器;医疗技术学;定义;距离;化学指示剂;设备;监督(认可);过程;试验;规范(验收);磁盘试验;非生物
【英文主题词】:
【摘要】:ThispartofISO11140specifiestheperformancerequirementsforaClass2indicatortobeusedasanalternativetotheBowieandDicktestforsteamsterilizersforwrappedhealthcaregoods(instruments,etc.andporousloads).AnindicatorcomplyingwiththispartofISO11140incorporatesaspecifiedmaterialwhichisusedasatestload.Thistestloadmay,ormaynot,bere-usable.ThispartofISO11140doesnotspecifyrequirementsforthetestload,butspecifiestheperformanceoftheindicatorsystemincombinationwiththetestloadwithwhichitisintendedtobeused:TheindicatorspecifiedinthispartofISO11140isintendedtoidentifypoorsteampenetrationbutdoesnotin-dicatenecessarilythecauseofthispoorsteampenetration.ThispartofISO11140doesnotincludetestmethodstoestablishthesuitabilityoftheseindicatorsforuseinsteriliz-ersinwhichtheairremovalstagedoesnotincludeevacuationbelowatmosphericpressure.NOTETheBowieandDickTestisperformedtodemonstrateconformanceofasteamsterilizerforwrappedhealthcaregoodstoEN285andmaybeusedasaroutinetestofperformanceofsuchasterilizer(seeISO11134).ThetestprocedureisdescribedinEN285.
【中国标准分类号】:C50
【国际标准分类号】:11_080_20
【页数】:33P;A4
【正文语种】:英语