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医疗设备的灭菌－微生物学方法第二部分：灭菌过程中无菌测试的定义，验证及维护Sterilizationofmedicaldevices-----Microbiologicalmethods-----Part2：Testsofsterilityperformedinthedefinition,validationandmaintenanceofasterilizationprocessISO11737-2:2009(E)国际标准ISO11737-22009-11-15第二版2ContentsPageForeword........................................................................ivIntroduction....................................................................v1Scope..........................................................................12Normativereferences................................................13Termsanddefinitions.............................................14Qualitymanagementsystemelements.................34.1Documentation......................................................34.2Managementresponsibility..................................34.3Productrealization.................................................44.4Measurement,analysisandimprovement............45Selectionofproduct..................................................45.1General...................................................................45.2Sampleitemportion(SIP).....................................45.3Packagingofproductandsampleitemportions…………………………………………….....56Methodsforperformingtestsofsterility.............57Assessmentofmethodforperformingtestsofsterility………………………………………………...68Maintenanceofthemethodforperformingtestsofsterility..........................................................6AnnexA(informative)Guidanceontestsofsterilityperformedinvalidationandmaintenanceofasterilizationprocess...............................................7Bibliography............................................................15ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part2.Themaintaskoftechnicalcommitteesistoprepare目录页码前言..................................................................iv介绍...........................................................v1范围.................................................................12参考标准..........................................................13条款和定义....................................................14质量管理体系基础..................................34.1文件.........................................................34.2管理职责…………………........................34.3产品实现....................................................44.4测量，分析及改进……………………........45产品的选择..............................................45.1总则......................................................45.2样品明细部分(SIP)..................................45.3产品和样品的包装部分……………………56进行无菌测试的方法…………………...........57进行无菌测试的评估………………….………...68进行无菌测试方法的维护...............................6附录A(提供信息用)消毒过程中，无菌测试验证和维护过程的指导...................................................7参考书目............................................................15前言ISO(国际标准化组织)是由各国标准化团体组成的世界性联合会。国际标准的准备工作通常是由ISO技术委员会准备的。各成员团体若对某技术委员会确立的标准项目感兴趣，均有权参加该委员会的工作。与ISO保持联系的各国际组织（官方的或非官方的）也可参加有关工作。在电工技术标准化方面，ISO与国际电工委员会（IEC）保持密切合作关系。国际标准的起草遵循ISO/IEC指令第2部分中的规则进行。技术委员会的主要任务是制定国际标准。由技术委3InternationalStandards.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ISO11737-2waspreparedbyTechnicalCommitteeISO/TC198,Sterilizationofhealthcareproducts.Thissecondeditioncancelsandreplacesthefirstedition(ISO11737-2:1998)whichhasbeentechnicallyrevised.ISO11737consistsofthefollowingparts,underthegeneraltitleSterilizationofmedicaldevices—Microbiologicalmethods: Part1:Determinationofapopulationofmicroorganismsonproducts Part2:Testsofsterilityperformedinthedefinition,validationandmaintenanceofasterilizationprocessIntroductionAsterilemedicaldeviceisonethatisfreefromviablemicroorganisms.InternationalStandardsthatspecifyrequirementsforvalidationandroutinecontrolofsterilizationprocessesrequire,whenitisnecessarytosupplyasterilemedicaldevice,thatadventitiousmicrobiologicalcontaminationofamedicaldevicefromallsourcesbeminimized.Evenso,medicaldevicesproducedunderstandardmanufacturingconditionsinaccordancewiththerequirementsforqualitymanagementsystems(see,forexample,ISO13485)may,priortosterilization,havemicroorganismsonthem,albeitinlownumbers.Suchproductsarenon-sterile.Thepurposeofsterilizationistoinactivatethemicrobiological