ISO 14644-3 2019 洁净室和相关受控环境-第3部分：测试方法（英文版）

©ISO2019Cleanroomsandassociatedcontrolledenvironments—Part3:TestmethodsSallespropresetenvironnementsmaîtrisésapparentés—Partie3:Méthodesd'essaiINTERNATIONALSTANDARDISO14644-3Secondedition2019-08ReferencenumberISO14644-3:2019(E)CopyrightInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithStandardsCouncilofCanadaNotforResale,09/15/201920:39:20MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,`,``,````,`,,````,,`,`,-`-`,,`,,`,`,,`---ISO14644-3:2019(E)ii©ISO2019–AllrightsreservedCOPYRIGHTPROTECTEDDOCUMENT©ISO2019Allrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofitsimplementation,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.ISOcopyrightofficeCP401•Ch.deBlandonnet8CH-1214Vernier,GenevaPhone:+41227490111Fax:+41227490947Email:copyright@iso.orgWebsite:www.iso.orgPublishedinSwitzerlandCopyrightInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithStandardsCouncilofCanadaNotforResale,09/15/201920:39:20MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,`,``,````,`,,````,,`,`,-`-`,,`,,`,`,,`---ISO14644-3:2019(E)Foreword........................................................................................................................................................................................................................................ivIntroduction..................................................................................................................................................................................................................................v1Scope.................................................................................................................................................................................................................................12Normativereferences......................................................................................................................................................................................13 Terms and definitions.....................................................................................................................................................................................13.1Generalterms...........................................................................................................................................................................................13.2Termsrelatedtoairborneparticles......................................................................................................................................33.3Termsrelatedtoairfiltersandsystems............................................................................................................................33.4Termsrelatedtoairflowandotherphysicalstates.................................................................................................43.5Termsrelatedtoelectrostaticmeasurement................................................................................................................53.6Termsrelatedtomeasuringapparatusandmeasuringconditions..........................................................53.7Termsrelatedtooccupancystates.........................................................................................................................................64Testprocedures.....................................................................................................................................................................................................64.1Cleanroomtests......................................................................................................................................................................................64.1.1General......................................................................................................................................................................................64.1.2Supportingtests...............................................................................................................................................................74.2Principle........................................................................................................................................................................................................74.2.1Airpressuredifferencetest....................................................................................................................................74.2.2Airflowtest...........................................................................................................................................................................74.2.3Airflowdirectiontestandvisualization......................................................................................................84.2.4Recoverytest.......................................................................................................................................................................84.2.5Temperaturetest.............................................................................................................................................................84.2.6Humiditytest......................................................................................................................................................................84.2.7Installedfiltersystemleakagetests................................................................................................................84.2.8Containmentleaktest..................................................................................................................................................84.2.9Electrostaticandiongeneratortests.............................................................................................................84.2.10Particledepositiontest...............................................................................................................................................84.2.11Segregationtest................................................................................................................................................................95Testreports................................................................................................................................................................................................................9AnnexA(informative)Choiceofsupportingtestsandchecklist.........................................................................................10AnnexB(informative)Supportingtestmethods..................................................................................................................................14AnnexC(informative)Testapparatus.............................................................................................................................................................44Bibliography.............................................................................................................................................................................................................................52©ISO2019–AllrightsreservediiiContentsPageCopyrightInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithStandardsCouncilofCanadaNotforResale,09/15/201920:39:20MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,`,``,````,`,,````,,`,`,-`-`,,`,,`,`,,`---ISO14644-3:2019(E)ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(seewww.iso.org/directives).Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived(seewww.iso.org/patents).Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO'sadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT)seewww.iso.org/iso/foreword.html.ThisdocumentwaspreparedbyISO/TC209,Cleanroomsandassociatedcontrolledenvironments.Anyfeedbackorquestionsonthisdocumentshouldbedirectedtotheuser’snationalstandardsbody.Acompletelistingofthesebodiescanbefoundatwww.iso.org/members.html.ThissecondeditionofISO14644-3cancelsandreplacesthefirstedition(ISO14644-3:2005),whichhasbeentechnicallyrevised.Themainchangescomparedtothepreviouseditionareasfollows:—ClauseB.7hasbeensimplifiedandcorrectedtoaddressconcernsoveritscomplexityandnotederrors;—guidanceconcerningclassificationofaircleanlinessbyairborneparticleconcentrationhasbeenmovedto14644-1[1]—thetextofthewholedocumenthasbeenrevisedorclarifiedtoaidinapplication.AlistofallpartsintheISO14644seriescanbefoundontheISOwebsite.iv©ISO2019–AllrightsreservedCopyrightInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithStandardsCouncilofCanadaNotforResale,09/15/201920:39:20MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,`,``,````,`,,````,,`,`,-`-`,,`,,`,`,,`---ISO14644-3:2019(E)IntroductionCleanroomsandassociatedcontrolledenvironmentsprovidecontrolofcontaminationtolevelsappropriateforaccomplishingcontamination-sensitiveactivities.Productsandprocessesthatbenefitfromthecontrolofairbornecontaminationincludethoseinsuchindustriesasaerospace,microelectronics,pharmaceuticals,medicaldevices,healthcareandfood.Thisdocumentsetsoutappropriatetestmethodsformeasuringtheperformanceofacleanroom,acleanzoneoranassociatedcontrolledenvironment,includingseparativedevicesandcontrolledzones,togetherwithallassociatedstructures,airtreatmentsystems,servicesandutilities.NOTENotallcleanroomparametertestproceduresareshowninthisdocument.TheprocedureandapparatusforthetestcarriedoutfortheaircleanlinessclassesbyparticleconcentrationandformacroparticlesareprovidedinISO14644-1,[1]andspecificationsformonitoringaircleanlinessbynanoscaleparticleconcentrationsareprovidedinISO14644-12.[8]Theproceduresandapparatustocharacterizeotherparameters,ofconcernincleanroomsandcleanzonesusedforspecificproductsorprocesses,arediscussedelsewhereinotherdocumentspreparedbyISO/TC209[forexample,proceduresforcontrolandmeasurementofviablematerials(ISO14698series),testingcleanroomfunctionality(ISO14644-4[3]),andtestingofseparativedevices(ISO14644-7[4])].Inaddition,otherstandardscanbeconsideredtobeapplicable.OthercleanlinessattributelevelscanbedeterminedusingISO14644-8[5](levelsofaircleanlinessbychemicals),ISO14644-9[6](levelsofsurfacecleanlinessbyparticleconcentration)andISO14644-10[7](levelsofsurfacecleanlinessbychemicalconcentration).©ISO2019–AllrightsreservedvCopyrightInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithStandardsCouncilofCanadaNotforResale,09/15/201920:39:20MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,`,``,````,`,,````,,`,`,-`-`,,`,,`,`,,`---CopyrightInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithStandardsCouncilofCanadaNotforResale,09/15/201920:39:20MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,`,``,````,`,,````,,`,`,-`-`,,`,,`,`,,`---Cleanroomsandassociatedcontrolledenvironments—Part3:Testmethods1ScopeThisdocumentprovidestestmethodsinsupportoftheoperationforcleanroomsandcleanzonestomeetaircleanlinessclassification,othercleanlinessattributesandrelatedcontrolledconditions.Performancetestsarespecifiedfortwotypesofcleanroomsandcleanzones:thosewithunidirectionalairflowandthosewithnon-unidirectionalairflow,inthreepossibleoccupancystates:as-built,at-restandoperational.Thetestmethods,recommendedtestapparatusandtestproceduresfordeterminingperformanceparametersareprovided.Wherethetestmethodisaffectedbythetypeofcleanroomorcleanzone,alternativeproceduresaresuggested.Forsomeofthetests,severaldifferentmethodsandapparatusarerecommendedtoaccommodatedifferentend-useconsiderations.Alternativemethodsnotincludedinthisdocumentcanbeusedbyagreementbetweencustomerandsupplier.Alternativemethodsdonotnecessarilyprovideequivalentmeasurements.Thisdocumentisnotapplicabletothemeasurementofproductsorofprocessesincleanrooms,cleanzonesorseparativedevices.NOTEThisdocumentdoesnotpurporttoaddresssafetyconsiderationsassociatedwithitsuse(forexample,whenusinghazardousmaterials,operationsandequipment).Itistheresponsibilityoftheuserofthisdocumenttoestablishappropriatesafetyandhealthpracticesandtodeterminetheapplicabilityofregulatorylimitationspriortouse.2NormativereferencesTherearenonormativereferencesinthisdocument.3 Terms and definitionsForthepurposesofthisdocument,thefollowingtermsanddefinitionsapply.ISOandIECmaintainterminologicaldatabasesforuseinstandardizationatthefollowingaddresses:—ISOOnlinebrowsingplatform:availableathttps://www.iso.org/obp—IECElectropedia:availableathttp://www.electropedia.org/3.1Generalterms3.1.1cleanroomroomwithinwhichthenumberconcentrationofairborneparticles(3.2.1)iscontrolledandclassified,andwhichisdesigned,constructedandoperatedinamannertocontroltheintroduction,generationandretentionofparticlesinsidetheroomNote1toentry:Theclassofairborneparticleconcentration(3.2.4)isspecified.INTERNATIONALSTANDARDISO14644-3:2019(E)©ISO2019–Allrightsreserved1CopyrightInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithStandardsCouncilofCanadaNotforResale,09/15/201920:39:20MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,`,``,````,`,,````,,`,`,-`-`,,`,,`,`,,`---ISO14644-3:2019(E)Note2toentry:Levelsofothercleanlinessattributessuchaschemical,viableornanoscaleconcentrationsintheair,andalsosurfacecleanlinessintermsofparticle,nanoscale,chemicalandviableconcentrationsmightalsobespecifiedandcontrolled.Note3toentry:Otherrelevantphysicalparametersmightalsobecontrolledasrequired,e.g.temperature,humidity,pressure,vibrationandelectrostatic.[SOURCE:ISO14644-1:2015,3.1.1]3.1.2cleanzonedefinedspacewithinwhichthenumberconcentrationofairborneparticles(3.2.1)iscontrolledandclassified,andwhichisconstructedandoperatedinamannertocontroltheintroduction,generationandretentionofcontaminantsinsidethespaceNote1toentry:Theclassofairborneparticleconcentration(3.2.4)isspecified.Note2toentry:Levelsofothercleanlinessattributessuchaschemical,viableornanoscaleconcentrationsintheair,andalsosurfacecleanlinessintermsofparticle,nanoscale,chemicalandviableconcentrationsmightalsobespecifiedandcontrolled.Note3toentry:Acleanzone(s)canbeadefinedspacewithinacleanroom(3.1.1)ormightbeachievedbyaseparativedevice.Suchadevicecanbelocatedinsideoroutsideacleanroom.Note4toentry:Otherrelevantphysicalparametersmightalsobecontrolledasrequired,e.g.temperature,humidity,pressure,vibrationandelectrostatic.[SOURCE:ISO14644-1:2015,3.1.2]3.1.3installationcleanroom(3.1.1)oroneormorecleanzones(3.1.2),togetherwithallassociatedstructures,air-treatmentsystems,servicesandutilities[SOURCE:ISO14644-1:2015,3.1.3]3.1.4separativedeviceequipmentutilizingconstructionalanddynamicmeanstocreateassuredlevelsofseparationbetweentheinsideandoutsideofadefinedvolumeNote1toentry:Someindustry-specificexamplesofseparativedevicesarecleanairhoods,containmentenclosures,gloveboxes,isolatorsandmini-environments.[SOURCE:ISO14644-7:2004,3.17]3.1.5resolutionsmallestchangeinaquantitybeingmeasuredthatcausesaperceptiblechangeinthecorrespondingindicationNote1toentry:Resolutioncandependon,forexample,noise(internalorexternal)orfriction.Itmayalsodependonthevalueofaquantitybeingmeasured.[SOURCE:ISO14644-1:2015,3.4.1]3.1.6sensitivityquotientofthechangeinanindicationofameasuringsystemandthecorrespondingchangeinavalueofthequantitybeingmeasured2©ISO2019–AllrightsreservedCopyrightInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithStandardsCouncilofCanadaNotforResale,09/15/201920:39:20MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,`,``,````,`,,````,,`,`,-`-`,,`,,`,`,,`---ISO14644-3:2019(E)3.2Termsrelatedtoairborneparticles3.2.1airborneparticlesolidorliquidobjectsuspendedinair,viableornon-viable,sizedbetween1nmand100µmNote1toentry:Forclassificationpurposes,refertoISO14644-1:2015,3.2.1.3.2.2countmedianparticlediametermedianparticlediameterbasedonthenumberofparticlesNote1toentry:Forthecountmedian,onehalfoftheparticlenumberiscontributedbytheparticleswithasizesmallerthanthecountmediansize,andonehalfbyparticleslargerthanthecountmediansize.3.2.3massmedianparticlediametermedianparticlediameterbasedontheparticlemassNote1toentry:Forthemassmedian,onehalfofmassofallparticlesiscontributedbyparticleswithasizesmallerthanthemassmediansize,andonehalfbyparticleslargerthanthemassmediansize.3.2.4particleconcentrationnumberofindividualparticlesperunitvolumeofair[SOURCE:ISO14644-1:2015,3.2.3]3.2.5particlesizediameterofaspherethatproducesaresponse,byagivenparticle-sizinginstrument,thatisequivalenttotheresponseproducedbytheparticlebeingmeasuredNote1toentry:Forlight-scatteringairborne-particleinstruments,theequivalentopticaldiameterisused.[SOURCE:ISO14644-1:2015,3.2.2]3.2.6particlesizedistributioncumulativedistributionofparticleconcentration(3.2.4)asafunctionofparticlesize(3.2.5)[SOURCE:ISO14644-1:2015,3.2.4]3.2.7testaerosolgaseoussuspensionofsolidand/orliquidparticleswithknownandcontrolledsizedistributionandconcentration3.3 Terms related to air filters and systems3.3.1aerosolchallengechallengingofafilteroraninstalledfiltersystem(3.3.6)bytestaerosol(3.2.7)3.3.2designatedleakmaximumallowablepenetration,whichisdeterminedbyagreementbetweencustomerandsupplier,throughaleak(3.3.8),detectableduringscanning(3.3.9)ofafilterinstallation(3.1.3)withlight-scatteringairborne-particlecounters(LSAPC)oraerosolphotometers(3.6.2)©ISO2019–Allrightsreserved3CopyrightInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithStandardsCouncilofCanadaNotforResale,09/15/201920:39:20MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,`,``,````,`,,````,,`,`,-`-`,,`,,`,`,,`---ISO14644-3:2019(E)3.3.3dilutionsystemsystemwhereinaerosolismixedwithparticle-freedilutionairinaknownvolumetricratiotoreduceconcentration3.3.4filter systemassemblycomposedoffilter,frameandothersupportmechanismorotherhousing3.3.5final filterfilterinafinalpositionbeforetheairentersthecleanroom(3.1.1)orcleanzone(3.1.2)3.3.6installed filter systemfiltersystem(3.3.4)mountedintheceiling,wall,apparatusorduct3.3.7installed filter system leakage testtestperformedtoconfirmthatthefiltersareproperlyinstalledbyverifyingthatthereisabsenceofbypassleakageofthefilterinstallation(3.1.3),andthatthefiltersandthegridsystemarefreeofdefectsandleaks(3.3.8)3.3.8leak<ofairfiltersystem>penetrationofcontaminantsthatexceed