【英文标准名称】:Sterilizationofhealthcareproducts-Biologicalindicators-Biologicalindicatorsforethyleneoxidesterilizationprocesses
【原文标准名称】:医疗保健产品灭菌.生物指示剂.环氧乙烷灭菌用生物指示剂
【标准号】:BSENISO11138-2-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-11-30
【实施或试行日期】:2009-11-30
【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】:细菌计数;生物测定;生物化学制品;生物指示剂;生物危害;生物系统;生物试验;效率;英语;环氧乙烷;评定;气体灭菌器;气体;病菌;指示器;医疗器械;医疗设备;医疗产品;医学科学;方法;微生物分析;微生物;性能;人口;规格试验;耐力;操作程序;规范;规范(验收);灭菌;灭菌器;杀菌器具;灭菌气体;生存特性;系统;试验细菌;试验生物体;测试;使用
【英文主题词】:Bacterialcount;Bioassay;Biochemicals;Bio-indicators;Biologicalhazards;Biologicalsystems;Biologicaltests;Efficiency;Englishlanguage;Ethyleneoxide;Evaluations;Gassterilizers;Gases;Germs;Indicators;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Methods;Microbiologicalanalysis;Microorganisms;Performance;Population;Ratingtests;Resistance;Sequenceofoperations;Specification;Specification(approval);Sterilization(hygiene);Sterilizers;Sterilizingapparatus;Sterilizinggases;Survivalcharacteristics;Systems;Testgerms;Testorganisms;Testing;Use
【摘要】:ThispartofISO11138providesspecificrequirementsfortestorganisms,suspensions,inoculatedcarriers,biologicalindicatorsandtestmethodsintendedforuseinassessingtheperformanceofsterilizersandsterilizationprocessesemployingethyleneoxidegasasthesterilizingagent,eitheraspureethyleneoxidegasormixturesofthisgaswithdiluentgases,atsterilizingtemperatureswithintherangeof29°Cto65°C.NOTE1RequirementsforvalidationandcontrolofethyleneoxidesterilizationprocessesareprovidedbyISO11135.NOTE2Nationalorregionalregulationscouldproviderequirementsforworkplacesafety.
【中国标准分类号】:C05
【国际标准分类号】:11_080_20
【页数】:14P.;A4
【正文语种】:英语