ISO14644-1：2015

©ISO2015Clanroomsandassociatdcontrolldnironmnts—Part1:ClassificationofairclanlinssbyparticlconcntrationSallsproprstnironnmntsmaîtrisésapparntés—Parti1:Classificationdlaproprtéparticulairdl’airINTERNATIONALSTANDARDISO146441Sconddition20151215RfrncnumbrISO146441:2015(E)CopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,ISO146441:2015(E)ii©ISO2015–AllrightsrsrdCOPYRIGHTPROTECTEDDOCUMENT©ISO2015,PublishdinSwitzrlandAllrightsrsrd.Unlssothrwisspcifid,nopartofthispublicationmaybrproducdorutilizdothrwisinanyformorbyanymans,lctronicormchanical,includingphotocopying,orpostingonthintrntoranintrant,withoutpriorwrittnprmission.PrmissioncanbrqustdfromithrISOatthaddrssbloworISO’smmbrbodyinthcountryofthrqustr.ISOcopyrightofficCh.dBlandonnt8CP401CH1214Vrnir,Gna,SwitzrlandTl.+41227490111Fax+41227490947copyright@iso.orgwww.iso.orgCopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,ISO146441:2015(E)Forword.iIntroduction.1Scop12Normatirfrncs..13Trmsanddfinitions.13.1Gnral..13.2Airbornparticls..23.3Occupancystats..33.4Tstinginstrumntation(sAnnxF)..33.5Instrumntspcifications..44Classification44.1Occupancystat(s)44.2Particlsiz(s)..44.3ISOClassnumbr.44.4Dsignation54.5Intrmdiatdcimalclanlinssclasssandparticlsizthrsholds.55Dmonstrationofcomplianc.65.1Principl..65.2Tsting65.3Airbornparticlconcntrationaluation65.4Tstrport6AnnxA(normati)Rfrncmthodforclassificationofairclanlinssbyparticlconcntration8AnnxB(informati)Examplsofclassificationcalculations13AnnxC(informati)Countingandsizingofairbornmacroparticls22AnnxD(informati)Squntialsamplingprocdur.27AnnxE(informati)Spcificationofintrmdiatdcimalclanlinssclasssandparticlsizthrsholds34AnnxF(informati)Tstinstrumnts..36Bibliography..37©ISO2015–AllrightsrsrdiiiContntsPagCopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,ISO146441:2015(E)ForwordISO(thIntrnationalOrganizationforStandardization)isaworldwidfdrationofnationalstandardsbodis(ISOmmbrbodis).ThworkofprparingIntrnationalStandardsisnormallycarridoutthroughISOtchnicalcommitts.Eachmmbrbodyintrstdinasubjctforwhichatchnicalcommitthasbnstablishdhasthrighttobrprsntdonthatcommitt.Intrnationalorganizations,gornmntalandnongornmntal,inliaisonwithISO,alsotakpartinthwork.ISOcollaboratscloslywiththIntrnationalElctrotchnicalCommission(IEC)onallmattrsoflctrotchnicalstandardization.ThprocdursusdtodlopthisdocumntandthosintnddforitsfurthrmaintnancardscribdinthISOIECDirctis,Part1.InparticularthdiffrntapproalcritrianddforthdiffrnttypsofISOdocumntsshouldbnotd.ThisdocumntwasdraftdinaccordancwiththditorialrulsofthISOIECDirctis,Part2(swww.iso.orgdirctis).Attntionisdrawntothpossibilitythatsomofthlmntsofthisdocumntmaybthsubjctofpatntrights.ISOshallnotbhldrsponsiblforidntifyinganyorallsuchpatntrights.DtailsofanypatntrightsidntifidduringthdlopmntofthdocumntwillbinthIntroductionandoronthISOlistofpatntdclarationsrcid(swww.iso.orgpatnts).Anytradnamusdinthisdocumntisinformationginforthconnincofusrsanddosnotconstitutanndorsmnt.ForanxplanationonthmaningofISOspcifictrmsandxprssionsrlatdtoconformityassssmnt,aswllasinformationaboutISO’sadhrnctothWTOprinciplsinthTchnicalBarrirstoTrad(TBT)sthfollowingURL:ForwordSupplmntaryinformationThcommittrsponsiblforthisdocumntisISOTC209,Clanroomsandassociatdcontrolldnironmnts.Thisscondditioncanclsandrplacsthfirstdition(ISO146441:1999),whichhasbntchnicallyrisdthroughout.ISO14644consistsofthfollowingparts,undrthgnraltitlClanroomsandassociatdcontrolldnironmnts:—Part1:Classificationofairclanlinssbyparticlconcntration—Part2:Monitoringtoproididncofclanroomprformancrlatdtoairclanlinssbyparticlconcntration—Part3:Tstmthods—Part4:Dsign,constructionandstartup—Part5:Oprations—Part7:Sparatidics(clanairhoods,globoxs,isolatorsandmininironmnts)—Part8:Classificationofairclanlinssbychmicalconcntration(ACC)—Part9:Classificationofsurfacclanlinssbyparticlconcntration—Part10:ClassificationofsurfacclanlinssbychmicalconcntrationAttntionisalsodrawntoISO14698,Clanroomsandassociatdcontrolldnironmnts—Biocontaminationcontrol:—Part1:Gnralprinciplsandmthods—Part2:Ealuationandintrprtationofbiocontaminationdatai©ISO2015–AllrightsrsrdCopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,ISO146441:2015(E)IntroductionClanroomsandassociatdcontrolldnironmntsproidforthcontrolofcontaminationofairand,ifappropriat,surfacs,tollsappropriatforaccomplishingcontaminationsnsitiactiitis.Contaminationcontrolcanbbnficialforprotctionofproductorprocssintgrityinapplicationsinindustrissuchasarospac,microlctronics,pharmacuticals,mdicaldics,halthcarandfood.ThispartofISO14644spcifisclasssofairclanlinssintrmsofthnumbrofparticlsxprssdasaconcntrationinairolum.Italsospcifisthstandardmthodoftstingtodtrminclanlinssclass,includingslctionofsamplinglocations.ThisditionisthrsultofarsponstoanISOSystmaticRiwandincludschangsinrsponstousrandxprtfdbackalidatdbyintrnationalnquiry.Thtitlhasbnrisdto“Classificationofairclanlinssbyparticlconcntration”tobconsistntwithothrpartsofISO14644.ThninISOclanlinssclasssarrtaindwithminorrisions.Tabl1dfinsthparticlconcntrationatariousparticlsizsforthninintgrclasss.TablE.1dfinsthmaximumparticlconcntrationatariousparticlsizsforintrmdiatclasss.Thusofthstablsnsursbttrdfinitionofthappropriatparticlsizrangsforthdiffrntclasss.ThispartofISO14644rtainsthmacroparticldscriptorconcpt;howr,considrationofnanoscalparticls(formrlydfindasultrafinparticls)willbaddrssdinasparatstandard.Thmostsignificantchangisthadoptionofamorconsistntstatisticalapproachtothslctionandthnumbrofsamplinglocations;andthaluationofthdatacollctd.Thstatisticalmodlisbasdonadaptationofthhyprgomtricsamplingmodltchniqu,whrsamplsardrawnrandomlywithoutrplacmntfromafinitpopulation.Thnwapproachallowsachlocationtobtratdindpndntlywithatlasta95%llofconfidncthatatlast90%ofthclanroomorclanzonaraswillcomplywiththmaximumparticlconcntrationlimitforthtargtclassofairclanlinss.Noassumptionsarmadrgardingthdistributionofthactualparticlcountsortharaofthclanroomorclanzon;whilinISO146441:1999anundrlyingassumptionwasthatthparticlcountsfollowthsamnormaldistributionacrossthroom,thisassumptionhasnowbndiscarddtoallowthsamplingtobusdinroomswhrthparticlcountsaryinamorcomplxmannr.Inthprocssofrisionithasbnrcognizdthatth95%UCLwasnithrappropriatnorwasapplidconsistntlyinISO146441:1999.Thminimumnumbrofsamplinglocationsrquirdhasbnchangd,compardwithISO146441:1999.Arfrnctabl,TablA.1,isproiddtodfinthminimumnumbrofsamplinglocationsrquirdbasdonapracticaladaptationofthsamplingmodltchniqu.Anassumptionismadthattharaimmdiatlysurroundingachsamplinglocationhasahomognousparticlconcntration.Thclanroomorclanzonaraisdiiddupintoagridofsctionsofnarqualara,whosnumbrisqualtothnumbrofsamplinglocationsdridfromTablA.1.Asamplinglocationisplacdwithinachgridsction,soastobrprsntatiofthatgridsction.Itisassumdforpracticalpurpossthatthlocationsarchosnrprsntatily;a“rprsntati”location(sA.4.2)mansthatfaturssuchasclanroomorclanzonlayout,quipmntdispositionandairflowsystmsshouldbconsidrdwhnslctingsamplinglocations.Additionalsamplinglocationsmaybadddtothminimumnumbrofsamplinglocations.Finally,thannxshabnrordrdtoimprothlogicofthispartofISO14644andportionsofthcontntofcrtainannxsconcrningtstingandtstinstrumntshabnincluddfromISO146443:2005.ThrisdrsionofthispartofISO14644addrsssth≥5µmparticllimitsforISOClass5inthstrilproductsannxsofthEU,PICSandWHOGMPsbywayofanadaptationofthmacroparticlconcpt.ThrisdrsionofthispartofISO14644nowincludsallmattrsrlatdtoclassificationofairclanlinssbyparticlconcntration.ThrisdrsionofISO146442:2015nowdalsxclusilywiththmonitoringofairclanlinssbyparticlconcntration.Clanroomsmayalsobcharactrizdbyattributsinadditiontothclassificationofairclanlinssbyparticlconcntration.Othrattributs,suchasairclanlinssintrmsofchmicalconcntration,may©ISO2015–AllrightsrsrdCopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,ISO146441:2015(E)bmonitordandthattribut’sgradorllmaybdsignatdalongwiththclassificationofthISOClassofclanlinss.Thsadditionalattributsdonotsufficalontoclassifyaclanroomorclanzon.i©ISO2015–AllrightsrsrdCopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,INTERNATIONALSTANDARDISO146441:2015(E)Clanroomsandassociatdcontrolldnironmnts—Part1:Classificationofairclanlinssbyparticlconcntration1ScopThispartofISO14644spcifisthclassificationofairclanlinssintrmsofconcntrationofairbornparticlsinclanroomsandclanzons;andsparatidicsasdfindinISO146447.Onlyparticlpopulationshaingcumulatidistributionsbasdonthrshold(lowrlimit)particlsizsrangingfrom0,1µmto5µmarconsidrdforclassificationpurposs.Thusoflightscattring(discrt)airbornparticlcountrs(LSAPC)isthbasisfordtrminationofthconcntrationofairbornparticls,qualtoandgratrthanthspcifidsizs,atdsignatdsamplinglocations.ThispartofISO14644dosnotproidforclassificationofparticlpopulationsthataroutsidthspcifidlowrthrsholdparticlsizrang,0,1µmto5µm.Concntrationsofultrafinparticls(particlssmallrthan0,1µm)willbaddrssdinasparatstandardtospcifyairclanlinssbynanoscalparticls.AnMdscriptor(sAnnxC)maybusdtoquantifypopulationsofmacroparticls(particlslargrthan5µm).ThispartofISO14644cannotbusdtocharactrizthphysical,chmical,radiological,iablorothrnaturofairbornparticls.2NormatirfrncsThfollowingdocumnts,inwholorinpart,arnormatilyrfrncdinthisdocumntandarindispnsablforitsapplication.Fordatdrfrncs,onlythditioncitdapplis.Forundatdrfrncs,thlatstditionofthrfrncddocumnt(includinganyamndmnts)applis.ISO146442:2015,Clanroomsandassociatdcontrolldnironmnts—Part2:MonitoringtoproididncofclanroomprformancrlatdtoairclanlinssbyparticlconcntrationISO146447,Clanroomsandassociatdcontrolldnironmnts—Part7:Sparatidics(clanairhoods,globoxs,isolatorsandmininironmnts)3TrmsanddfinitionsForthpurpossofthisdocumnt,thfollowingtrmsanddfinitionsapply.3.1Gnral3.1.1clanroomroomwithinwhichthnumbrconcntrationofairbornparticlsiscontrolldandclassifid,andwhichisdsignd,constructdandopratdinamannrtocontrolthintroduction,gnrationandrtntionofparticlsinsidthroomNot1tontry:Thclassofairbornparticlconcntrationisspcifid.©ISO2015–Allrightsrsrd1CopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,ISO146441:2015(E)Not2tontry:Llsofothrclanlinssattributssuchaschmical,iablornanoscalconcntrationsinthair,andalsosurfacclanlinssintrmsofparticl,nanoscal,chmicalandiablconcntrationsmightalsobspcifidandcontrolld.Not3tontry:Othrrlantphysicalparamtrsmightalsobcontrolldasrquird,.g.tmpratur,humidity,prssur,ibrationandlctrostatic.3.1.2clanzondfindspacwithinwhichthnumbrconcntrationofairbornparticlsiscontrolldandclassifid,andwhichisconstructdandopratdinamannrtocontrolthintroduction,gnrationandrtntionofcontaminantsinsidthspacNot1tontry:Thclassofairbornparticlconcntrationisspcifid.Not2tontry:Llsofothrclanlinssattributssuchaschmical,iablornanoscalconcntrationsinthair,andalsosurfacclanlinssintrmsofparticl,nanoscal,chmicalandiablconcntrationsmightalsobspcifidandcontrolld.Not3tontry:Aclanzon(s)canbadfindspacwithinaclanroomormightbachidbyasparatidic.Suchadiccanblocatdinsidoroutsidaclanroom.Not4tontry:Othrrlantphysicalparamtrsmightalsobcontrolldasrquird,.g.tmpratur,humidity,prssur,ibrationandlctrostatic.3.1.3installationclanroomoronormorclanzons,togthrwithallassociatdstructurs,airtratmntsystms,sricsandutilitis3.1.4classificationmthodofassssingllofclanlinssagainstaspcificationforaclanroomorclanzonNot1tontry:LlsshouldbxprssdintrmsofanISOClass,whichrprsntsmaximumallowablconcntrationsofparticlsinaunitolumofair.3.2Airbornparticls3.2.1particlminutpicofmattrwithdfindphysicalboundaris3.2.2particlsizdiamtrofasphrthatproducsarspons,byaginparticlsizinginstrumnt,thatisquialnttothrsponsproducdbythparticlbingmasurdNot1tontry:Fordiscrtparticllightscattringinstrumnts,thquialntopticaldiamtrisusd.3.2.3particlconcntrationnumbrofindiidualparticlsprunitolumofair3.2.4particlsizdistributioncumulatidistributionofparticlconcntrationasafunctionofparticlsiz3.2.5macroparticlparticlwithanquialntdiamtrgratrthan5µm2©ISO2015–AllrightsrsrdCopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,ISO146441:2015(E)3.2.6Mdscriptordsignationformasurdorspcifidconcntrationofmacroparticlsprcubicmtrofair,xprssdintrmsofthquialntdiamtrthatischaractristicofthmasurmntmthodusdNot1tontry:ThMdscriptorcanbrgarddasanupprlimitfortharagsatsamplinglocations.MdscriptorscannotbusdtodfinISOClasss,butthMdscriptormaybquotdindpndntlyorinconjunctionwithISOClasss.3.2.7unidirctionalairflowcontrolldairflowthroughthntircrosssctionofaclanroomoraclanzonwithastadylocityandairstramsthatarconsidrdtobparalll3.2.8nonundirctionalairflowairdistributionwhrthsupplyairntringthclanroomorclanzonmixswiththintrnalairbymansofinduction3.3Occupancystats3.3.1asbuiltconditionwhrthclanroomorclanzoniscompltwithallsricsconnctdandfunctioningbutwithnoquipmnt,furnitur,matrialsorprsonnlprsnt3.3.2atrstconditionwhrthclanroomorclanzoniscompltwithquipmntinstalldandopratinginamannragrdupon,butwithnoprsonnlprsnt3.3.3oprationalagrdconditionwhrthclanroomorclanzonisfunctioninginthspcifidmannr,withquipmntopratingandwiththspcifidnumbrofprsonnlprsnt3.4Tstinginstrumntation(sAnnxF)3.4.1rsolutionsmallstchanginaquantitybingmasurdthatcaussaprcptiblchanginthcorrspondingindicationNot1tontry:Rsolutioncandpndon,forxampl,nois(intrnalorxtrnal)orfriction.Itmayalsodpndonthaluofaquantitybingmasurd.[SOURCE:ISOIECGuid99:2007,4.14]3.4.2maximumprmissiblmasurmntrrorxtrmaluofmasurmntrror,withrspcttoaknownrfrncquantityalu,prmittdbyspcificationsorrgulationsforaginmasurmnt,masuringinstrumnt,ormasuringsystmNot1tontry:Usually,thtrm“maximumprmissiblrrors”or“limitsofrror”isusdwhrthrartwoxtrmalus.Not2tontry:Thtrm“tolranc”shouldnotbusdtodsignat“maximumprmissiblrror”.[SOURCE:ISOIECGuid99:2007,4.26]©ISO2015–Allrightsrsrd3CopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,ISO146441:2015(E)3.5Instrumntspcifications3.5.1LSAPClightscattringairbornparticlcountrlightscattringdiscrtairbornparticlcountrinstrumntcapablofcountingandsizingsinglairbornparticlsandrportingsizdataintrmsofquialntopticaldiamtrNot1tontry:ThspcificationsforthLSAPCargininISO215014:2007.3.5.2discrtmacroparticlcountrinstrumntcapablofcountingandsizingsinglairbornmacroparticlsNot1tontry:STablF.1forspcifications.3.5.3timofflightparticlsizingapparatusdiscrtparticlcountingandsizingapparatusthatdfinstharodynamicdiamtrofparticlsbymasuringthtimforaparticltoaccommodattoachanginairlocityNot1tontry:Thisisusuallydonbymasuringthparticltransittimopticallyaftrafluidstramlocitychang.Not2tontry:STablF.2forspcifications.4Classification4.1Occupancystat(s)Thairclanlinssclassbyparticlconcntrationofairinaclanroomorclanzonshallbdfindinonormorofthroccupancystats,iz.“asbuilt,”“atrst”or“oprational”(s3.3).4.2Particlsiz(s)On,ormorthanon,thrshold(lowrlimit)particlsizssituatdwithinthrangfrom≥0,1µmto≥5µmartobusdtodtrminairclanlinssparticlconcntrationforclassification.4.3ISOClassnumbrAirclanlinssclassbyparticlconcntrationshallbdsignatdbyanISOClassnumbr,N.ThmaximumprmittdconcntrationofparticlsforachconsidrdparticlsizisdtrmindfromTabl1.ParticlnumbrconcntrationsfordiffrntthrsholdsizsinTabl1donotrflctactualparticlsizandnumbrdistributioninthairandsrascritriaforclassificationonly.ExamplsofclassificationcalculationsarincluddinAnnxB.4©ISO2015–AllrightsrsrdCopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,ISO146441:2015(E)Tabl1—ISOClasssofairclanlinssbyparticlconcntrationISOClassnumbr(N)Maximumallowablconcntrations(particlsm3)forparticlsqualtoandgratrthanthconsidrdsizs,shownblowa0,1µm0,2µm0,3µm0,5µm1µm5µm110bdddd210024b10bdd3100023710235bd4100002370102035283b510000023700102003520832d,,f610000002370001020003520083202937ccc3520008320029308ccc3520000832000293009gccc352000008320000293000aAllconcntrationsinthtablarcumulati,.g.forISOClass5,th10200particlsshownat0,3µmincludallparticlsqualtoandgratrthanthissiz.bThsconcntrationswillladtolargairsamplolumsforclassification.Squntialsamplingprocdurmaybapplid;sAnnxD.cConcntrationlimitsarnotapplicablinthisrgionofthtabldutoryhighparticlconcntration.dSamplingandstatisticallimitationsforparticlsinlowconcntrationsmakclassificationinappropriat.Samplcollctionlimitationsforbothparticlsinlowconcntrationsandsizsgratrthan1μmmakclassificationatthisparticlsizinappropriat,dutopotntialparticllosssinthsamplingsystm.fInordrtospcifythisparticlsizinassociationwithISOClass5,thmacroparticldscriptorMmaybadaptdandusdinconjunctionwithatlastonothrparticlsiz.(SC.7.)gThisclassisonlyapplicablforthinoprationstat.4.4DsignationThdsignationofairbornparticlconcntrationforclanroomsandclanzonsshallincluda)thISOClassnumbr,xprssdas“ISOClassN”,b)thoccupancystattowhichthclassificationapplis,andc)thconsidrdparticlsiz(s).Ifmasurmntsartobmadatmorthanonconsidrdparticlsiz,achlargrparticldiamtr(.g.D2)shallbatlast1,5timsthnxtsmallrparticldiamtr(.g.D1),i..D2≥1,5×D1.EXAMPLEISOClassnumbr;occupancystat;considrdparticlsiz(s)ISOClass4;atrst;0,2µm,0,5µm4.5IntrmdiatdcimalclanlinssclasssandparticlsizthrsholdsWhrintrmdiatclasss,orintrmdiatparticlsizthrsholdsforintgrandintrmdiatclasssarrquird,rfrtoinformatiAnnxE.©ISO2015–Allrightsrsrd5CopyrightIntrnationalOrganizationforStandardizationProiddbyIHSundrlicnswithISOLicns=BctonDickinson5984713001,Usr=Zhu,JssicaNotforRsal,1229201502:34:45MSTNorproductionorntworkingprmittdwithoutlicnsfromIHS,,,,,,,,,,,,,,,,,,,,,,,ISO146441:2015(E)5Dmonstrationofcomplianc5.1PrinciplCompliancwithairclanlinss(ISOClass)rquirmntsspcifidbythcustomrisrifidbyprformingspcifidtstingprocdursandbyproidingdocumntationofthrsultsandconditionsoftsting.Atrstoroprationalclassificationmaybprformdpriodicallybasduponriskassssmntofthapplication,typicallyonanannualbasis.Formonitoringclanrooms,clanzonsandsparatidics,ISO146442:2015shallbusd.NOTEWhrthinstallationisquippdwithinstrumntationforcontinuousorfrquntmonitoringofairclanlinssbyparticlconcntrationandothrparamtrsofprformancasapplicabl,thtimintralsbtwnclassificationmaybxtnddproiddthatthrsultsofthmonitoringrmainwithinthspcifidlimits.5.2TstingThrfrnctstmthodfordmonstratingcompliancisgininAnnxA(normati).Altrnatimthodsorinstrumntation(orboth),haingatlastcomparablprformanc,maybspcifid.Ifnoaltrnatiisspcifidoragrdupon,th