新版洁净室基本知识

WINIFREDAbstract概要AbstractAbstract概要概要¾Glossaryanddefinitions术语和定义¾Cleanroomstandards洁净室相关标准¾Theprincipalsofhowacleanroomworks洁净室工作原理¾Contaminationcontrolincleanroom洁净室的污染控制¾Cleanroomoperation洁净室设备Glossaryanddefinitions术语和定义Micron:Moreproperly,micrometer;alengthequaltoonemillionthofameter,oftenwrittenμm.微米：长度单位，等于百万分之一米，常用μm表示。Angstrom(Ǻ):Unitoflength,1Ǻ=1x10-10m,10000Ǻ=1μm埃(Ǻ)：长度单位，1埃=1x10-10米,10000埃=1微米HEPAFilter:AcronymforHighEfficiencyParticulateAirfilter,typicalfilterefficienciesforHEPAfiltersare99.997%@0.3μmdiameter高效空气微粒过滤器：典型过滤效率为99.997%@0.3μm直径粒子ULPAFilter:AcronymforUltra-LowParticulateAirfilter,typicalefficienciesforULPAfiltersare99.999997%@0.12μmdiameter超高效空气微粒过滤器：典型过滤效率为99.999997%@0.12μm直径粒子ParticulateContaminants:Solidparticlesinthe0.01to100μmsizerange微粒污染物：大小在0.01to100μm之间的实心微粒。Glossaryanddefinitions术语和定义AMC:AcronymforAirborneMolecularContamination,chemicalcontaminationthatoccursuponexposuretoairbornegasesandvaporsduringproducthandling,storageandtransport.空气传播分子污染：在产品的搬运、储存和运输过程中暴露在空气传播的气体和蒸气下所造成的化学污染。Ion:Anatomorgroupofatomscarryapositiveornegativechargeasaresultofhavinggainedorlostoneormoreelectrons.离子：得到或失去一个或一个以上电子的带正电荷或负电荷的原子或原子群。FFU:AcronymforFanFilterUnit,oftenwithanHEPA/ULPAfilterunderneath.风机过滤器单元：配合HEPA或ULPA过滤器使用的一种末端送风过滤系统。Glossaryanddefinitions术语和定义Class:AsdefinedinFEDSTD209,internationalStandardISO14644thenumberofparticlesfoundpervolumeofair.洁净度等级：如同联邦标准209和国际标准ISO14644规定的，单位容积空气中发现的粒子的数量。CleanZoom:Adefinedspaceinwhichtheconcentrationofairborneparticlesiscontrolledtometaspecifiedairbornecleanlinessclass.洁净区：空气中微粒的数量控制在规定的洁净度等级范围内的特定区域。Cleanroom:Anenclosedareawithcontroloverairborneparticlesaswellasotherfactorsasneeded(suchasairvelocityanddirection,temperature,humidity,pressure,molecularcontamination)洁净室：根据需要对空气的传播粒子和其他因素进行控制（例如气流速度和方向、温度、湿度、压力、分子污染等）的一个密闭区域。Glossaryanddefinitions术语和定义As-BuiltCleanroom:Acleanroomthatiscompleteandreadyforopration,withallservicesconnectedandfunctional,butwithoutequipmentofoperatingpersonnelinthefacility.空态洁净室：已经建造完成并可以投入使用的洁净室，它具备所有相关的功能，但是室内没有任何生产设备和操作人员。At-RestCleanroom:Acleanroomthatiscompletewithallservicesconnectedfunctioningandwithequipmentinstalledandoperableoroperating,asspecified,butwithoutoperatingpersonnelinthefacility.静态洁净室：室内各种设备安装完毕，可以随时投入运行的洁净室。但是室内没有操作人员。OperationalCleanroom:Acleanroominnormaloperationwithservicesfunctioningandwithequipmentandpersonnel.动态洁净室：处于正常使用的洁净室，包括所有的设备和操作人员。CleanroomStandards洁净室相关标准FEDSTD209ECANCELCleanroomStandards洁净室相关标准ISOTC20914644-1:CleanroomsandAssociatedControlledEnvironmentsPart1,Classificationofaircleanliness.洁净室与相关的受控环境第一部分：空气洁净度的分级。14644-2:CleanroomsandAssociatedControlledEnvironmentsPart2,SpecificationsfortestingandmonitoringtoprovecontinuedcompliancewithISO14644-1.洁净室与相关的受控环境第二部分：保证ISO14644-1持续有效的检测与监测规范。14644-3:CleanroomsandAssociatedControlledEnvironmentsPart3,Metrologyandtestmethods.洁净室与相关的受控环境第三部分：计量与测试方法。CleanroomStandards洁净室相关标准ISOTC20914644-4:CleanroomsandAssociatedControlledEnvironmentsPart4,Design,constructionandstartup.洁净室与相关的受控环境第四部分：设计、建造与启动。14644-5:CleanroomsandAssociatedControlledEnvironmentsPart5,Operations.洁净室与相关的受控环境第五部分：运行。14644-6:CleanroomsandAssociatedControlledEnvironmentsPart6,Termsanddefinitions.洁净室与相关的受控环境第六部分：术语与定义。14644-7:CleanroomsandAssociatedControlledEnvironmentsPart7,Minienvironmentsandisolators.洁净室与相关的受控环境第七部分：微环境与隔离。CleanroomStandards洁净室相关标准ISOTC20914698-1:CleanroomsandAssociatedControlledEnvironments,BiocontaminationcontrolPart1,Generalprinciples.洁净室与相关的受控环境，生物污染控制，第一部分：总则。14698-2:CleanroomsandAssociatedControlledEnvironments,BiocontaminationcontrolPart2,Evaluationandinterpretationofbiocontaminationdata.洁净室与相关的受控环境，生物污染控制，第二部分：生物污染数据的评估与解释。14698-3:CleanroomsandAssociatedControlledEnvironments,BiocontaminationcontrolPart3,Metrologyformeasuringtheefficiencyofprocessesofcleaninganddisinfectionofinsertsurfacesbearingbiocontaminatedwetsoilingorbiofilms.洁净室与相关的受控环境，生物污染控制，第三部分：评测受到生物污染的湿污染或生物膜清洁和消毒方法的有效性。CleanroomStandards洁净室相关标准293,0008,320,00035,200,000ISO929,300832,0003,520,000ISO82,93083,200352,000ISO72938,32035,200102,000237,0001,000,000ISO6298323,52010,20023,700100,000ISO5833521,0202,37010,000ISO48351022371,000ISO341024100ISO2210ISO15um1um0.5um0.3um0.2um0.1umNumberofParticlesperCubicMeterbyMicrometerSize（颗粒数/立方米）CLASSISO14644-1CleanroomStandards洁净室相关标准ISO9M6.5100,000ISO8M5.510,000ISO7M4.51,000ISO6M3.5100ISO5M2.510ISO4M1.51ISO3ISO2ISO1MetricEnglishClassFEDSTD209EISO14644-1CompareFEDSTD209EtoISO14644-1CleanroomStandards洁净室相关标准ISO14644-1AnnexB412MonthsAllClassesAirflowISO14644-1AnnexB512MonthsAllClassesAirPressureDifference12MonthsISO5ISO14644-1AnnexA6Months=ISO5ParticleCountTestTestProcedureMaximumTimeIntervalClassTestParameterScheduleofTeststoDemonstrateContinuingComplianceISO14644-2(RequiredTest)CleanroomStandards洁净室相关标准TestProcedureMaximumTimeIntervalClassTestParameterISO14644-3AnnexB724MonthsAllClassesAirflowVisualizationISO14644-3AnnexB1324MonthsAllClassesRecoveryISO14644-3AnnexB424MonthsAllClassesContainmentLeakageISO14644-3AnnexB624MonthsAllClassesInstalled