【英文标准名称】:Sterilizationofhealthcareproducts-Biologicalindicators-Part1:Generalrequirements
【原文标准名称】:医疗保健产品灭菌.生物指示物.第1部分:一般要求
【标准号】:ISO11138-1-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-07
【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】:细菌计数;生物化学制品;生物指示剂;生物分析和试验;生物分析;生物学;培养(生物);定义;效率;孵蛋;指示器;医学科学;微生物分析;微生物;生产;公共卫生;规格试验;耐力;规范(验收);灭菌;灭菌器;杀菌器具;监督(认可);系统;试验细菌;试验货物;试验
【英文主题词】:Bacterialcount;Biochemicals;Bio-indicators;Biological;Biologicalanalysisandtesting;Biologicalhazards;Biologicalsystems;Biology;Checks;Conditions;Culture;Cultures(biology);Definitions;Efficiency;Germs;Incubation;Indicators;Inoculation;Markingofroads;Materials;Mathematicalcalculations;Medicalsciences;Methods;Microbiologicalanalysis;Microorganisms;Nutrientmedium;Packages;Preparation;Production;Publichealth;Ratingtests;Resistance;Sequenceofoperations;Specification(approval);Sterilization(hygiene);Sterilizers;Sterilizingapparatus;Surveillance(approval);Survivalcharacteristics;Systems;Testgerms;Testgoods;Testing
【摘要】:1.1General1.1.1ThispartofISO11138providesgeneralrequirementsforproduction,labelling,testmethodsandperformancecharacteristicsofbiologicalindicators,includinginoculatedcarriersandsuspensions,andtheircomponents,tobeusedinthevalidationandroutinemonitoringofsterilizationprocesses.1.1.2ThispartofISO11138specifiesbasicandcommonrequirementsthatareapplicabletoallsubsequentpartsofISO11138.RequirementsforbiologicalindicatorsforparticularspecifiedprocessesareprovidedinthesubsequentpartsofISO11138.Ifnospecificsubsequentpartisprovided,thispartapplies.NOTENationalorregionalregulationsmayapply.1.2ExclusionsThispartofISO11138doesnotapplytomicrobiologicaltestsystemsforprocessesthatrelyonphysicalremovalofmicroorganisms,e.g.filtrationprocessesorprocessesthatcombinephysicaland/ormechanicalremovalwithmicrobiologicalinactivation,suchasuseofwasherdisinfectorsorflushingandsteamingofpipelines.ThispartofISO11138,however,couldcontainelementsrelevanttosuchmicrobiologicaltestsystems.
【中国标准分类号】:C10
【国际标准分类号】:11_080_20
【页数】:38P;A4
【正文语种】:英语