(高清版)GBT 25915.8-2021 洁净室及相关受控环境 第8部分：按化学物浓度划分空气洁净度(ACC)等级

洁净室及相关受控环境第8部分：按化学物浓度划分空气洁净度(ACC)等级Part8:Classificationofaircleanlinessbychemicalcon国家标准化管理委员会国家市场监督管理总局发布国家标准化管理委员会 I 3 5附录A(资料性)影响ACC的因素 6附录B(资料性)常见污染物 9附录C(资料性)常用测量方法 附录D(资料性)隔离装置的特殊要求 第3部分：检测方法：本文件代替GB/T25915.8—2010《洁净室及相关受控环境第8部分：空气分子污染分级》,与表B.1);ⅢGB/T25915.8—2021/ISO1——附录B:常见污染物；——附录C:常用测量方法；本文件是有关洁净室及相关受控环境的GB/T25915的1个部分，除ACC外，洁的其他国家标准中。要特别注意GB/T25915的所有部分。有些情况下，相关管理机构可能会规定某1GB/T25915.8—2021/ISO1本文件目前只考虑洁净室运行工况下空气中10°g/m³~10-¹²g/m³GB/T25915.6洁净室及相关受控环境第6部分：词汇(GB/T25915—2010,ISO14644-6:GB/T25915.6界定的以及下列术语和定义适用于本文件。2GB/T25915.8—2021/ISO13GB/T25915.8—2021/ISO1种污染物或某组污染物的最大允许浓度。常见污染物见附录B。●生物毒素(bt);●可凝聚物(cd);●总有机化合物(toc);N=log₁₀[cx]。表1和图1给出污染物浓度与ISO-ACC等级的对应关系。ISO-ACC等级04ACC等级GB/T25915.8—2021/ISO1ACC等级ISO-ACC等级图1空气中化学物浓度与ISO-ACC等级的对应关系5应记录每个洁净室或相关受控环境的检测结果并提交综合性报告，报告中应写明与规定的c)被测洁净室或受控环境的具体位置(必要时以相邻区域6本附录给出洁净室及相关受控环境内影响或造成ACC的各种因素，这些因素在工程设计初始阶1)室外空气(向设施提供新风);2)设施内的建筑材料，特别是接触循环风和新风的材料；3)设施内可能发生的交叉污染；4)设施的运行和维护；5)人员、洁净工作服和辅助材料；6)工艺介质和工器具。对这些情况的进一步说明见A.3～A.8。e)为防止或减少由d)所列因素产生的化学污染，确定相应的设计要求，以达到产品或工艺所需7GB/T25915.4—2010的附录E给出了一些洁净室适用建筑材料示例。A.4.3在许多情况下，建筑材料的释出气体可在一个时间段呈指数大程度地减少或防止交叉污染。GB/T25915.4—2010中附录A和GB/T25915.7给出了这样的示例。A.7人员-—个人对清洁和消毒材料的使用。89GB/T25915.8—2021/ISO1(资料性)关注的具体化合物对洁净室环境内生产的最终产品的有害化学反应，对污染物进行分类。表B.1给出能影响产品或工艺的常见化学污染物和污染物类别。用户可CAS登记号物质污染物类别“HML氨氯XXx××XXXXXXXXXBHT:2(t-乙酸丁脂)邻苯二甲酸丁苄酯(BBP)氧化硼XXXXXXXXXXXESi(CH₃)₂O子XXXXXX己二酸二(乙基己基)酯邻苯二甲酸二癸酯十甲基环五硅氧烷ESi(CH₃)2O子₅ESi(CH₃)20子。XXXXXXXXXXX×XXXxXXxXXX×X×XX××X表B.1能影响产品或工艺的常见化学污染物示例及其分类(续)CAS登记号物质污染物类别“HML×XX己醛ESi(CH₃)2O子3XX×xXXXXXXXXXXXXX×X×XXXX×X—(NCH₃)(C=O)(CH₂)₃一×××X××X×X××ESi(CH₃)₂O子4XXXX×XX×XXXXX磷酸三(1-氯-2-丙基)酯四甲基氢氧化铵XXXX×X×X×X×××XXX××XXX×XX×XXXX×XXXXESi(CH₃)2O子。(X为任意元素)X×××XXXXX×X×X××XX×XXXXXGB/T25915.8—2021/ISO1表B.1能影响产品或工艺的常见化学污染物示例及其分类(续)物质污染物类别HML总非甲烷烃衍生物总非饱和烃衍生物(X为任意元素)XXXXXXXXH:高凝性，沸点>200℃;M:中凝性，200℃≥T₆≥100℃;L:低凝性，100℃>T₆(Tb为沸点)。GB/T25915.8—2021/ISO1(资料性)C.1.1本附录给出了化学污染化合物及其预期浓度C.2.4无源扩散采样器(DIFF)利用特别制备的表面，选择性地收集一种或数种气体成分。这种方法对低浓度ACC,需要较长的采样时间。C.2.5有源采样器是将确定量的空气抽取通过吸附介质所进行的污染物采样。这种技术能在较短的 -—离子色谱监测系统(ICS);GB/T25915.8—2021/ISO1用户宜注意检出限并保持在其范围内。回收率宜在75%～125%。上述测量方法列于表C.1。等级污染物类别酸碱0SB,GC-FID,注：表中缩写所代表的方法见C.3。要考虑到这些特点。本附录意在为这些隔离装置提供指导。隔离装置的各种类型和应用见D.1.2宜考虑隔离装置本身造成污染的可能性。有些场合无法直接测量ACC(例如，量太低),此时，确定污染程度的唯一方法是测量表面化学物D.2.1屏障技术限制着ACC采样方法和分析方法的选择。需方和供方宜通过协商确定最佳检测方D.2.2宜按附录A的说明选择制造隔离装置的D.2.4需要对产品给予特别关注的场合，可通过测量和分析产品的表面化学污染来验证装置的性能(见D.1.2)。D.2.7为控制空气化学污染，特定的行业能有特定的推荐性检测方法或检测技术要求，或检测指南。[2]GB/T25915.5洁净室及相关受控环境第5部分：运行(GB/T25915.5—2010,[5]SEMIF21-1102Classification[6]TechnologyRoadmapforSe[9]JACANo.34:2000StandardforEvaluationofAirborneMolecularContam[10]JACANo.35A:2003StandardforClassificati[12]SEMIE108-0301TestMethodfortheAssessmentofOutgassin[14]IDEMAStandardM11-99Gen[15]JISB9917-8:2010StandardforClassificationofAirCleanlinessf[16]AirborneMolecularcontamination.Fujimoto.T,Takeda,Kand[17]SEMIE45-1101TestMethodforMinienvironmentsUsingVapourPhaseDecomposition-TotalReflectionX-RTXRF),VPD-AtomicAbsorptionSpectroscory(VPD-AAS),orVPD/InductMassSpectrometry(VPD/ICP-MS)[18]SEMIE460307TestMethenvironmentsUsingIon[19]TakedaK.,MochizukiA.,NonakaT.,MatsumotoI.,NakaharaT.EvaluationofsingcompoundsfromCleanroomConstructionMa[20]TamuraH.,FujiiS.,YuasaK.andKagiN.CleanroomMaterialsusingtheDoubleCylinderChamber.JourronmentalEngineering,No.520,pp.55-59(1999).[21]TamuraH.,FujiiS.,KagiN.EstimateofContaminationControl,ESTECH2002Proceedings,pp7-15,Anaheim,CalifBUEE2001,Seoul,Korea(2001).Sallespropresetenvironnementsmaitrisésapparentés—Partie8:ClassificationdelapropretéchimiquedeIairCopyrightIntermationalOrganizatioNorepnetworkingpermittedwLicensee=UniversiyofAlberta/5966844001,User=sharabiani,shahramlsr 12Normativereferences 13Termsanddefini 1 1 2 3 3 3 5 5 55.3Testreport 6 7 bodies(ISOmemberbodies).Theworkofcommitteehasbeenestablishedhastherighttoberepresentedonthatcommitteeorganizations,governmentalandnollaboratescloselywitfelectrotechnicalstandardization.ThemaintaskoftechnicalcommitteesistoprepareInternationalStandards.DraftInternatiStandardsadoptedbyAttentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectof—Part3:Testmethods—Part4:Design,constructionandstart-upCopyightIntenationalOranioreproductionornetworkingpermdwithoutlicensefromdNotforRasale,12/02/Cleanroomsandassociatedcontrolledenvironcontaminationtolevelsappropriateforaccomplishingcontamination-sensprocessesthatbenefitfromthaerospace,microelectronics,pharmaceuticals,medicaldevices,food,healthcare,opvacuumtechnology,coatings,photovoltaics,displays,sepcssanittryWithinthispartofISO14steps,notonlythecontaminantsbutalsotheinvolvedcleanroomandassociatedcontrolledenvironment,wheretheprstandardprotocolsforspecifyingsuchlevelswithregardtochemicalcompoundanalysis,andtimeweightecontrol.Manyfactorsbcircumstances,relevantregulatoryagenciescanimposesuppsituations,appropriateadaptationsofthispartofISO14644canberequired.NorepoductionornetwoerngermiVLicensee=UniversiyofAlberta/5966844001,User=sharabiani,shNotforRasale,12/02/201309ThispartofISO14644andassociatedcontrolledenvironments,intermsofairborneconcsubstances(individuthepresenceofairbornechemicalsubsItisnottheintentionofthISO14644-6,Cleanroomsandassociatedcontrolledenvironments—Part6:VocabularyForthepurposesofthisdocument,thetermsanddefinitionslevelofaircleanlinessbychemicalconcentraanysubstanceintheairthatcan,byitschemicalnature,adverselyaffecttheproductgntsrese1License=UniversityofAlberta/5966844001,User=sharabiani,shahramlconditionofthesurfacecleanlinesswithrespecttoreleaseofchemicalsubstancesNote5toentry:IntermediateISOclassificationnumbersmaybespeci3.2Contaminantcategoriescfcontaminantsubstancethatisobnoxioustothedevelopmentandpreservationofthelifeoforganisms,2Licensee=UniversityofAlberta/5966844001,User=sharabianionanfchangingthepropertiesofmaterials,evenintraceamountsspeciesbasedoncarbon-contsubstancethat,upondepositionontoorparticipatesinaredoxAnACCclassnumberisonlyvalidinconnectionwiththeNistheISO-ACCclass,whichipercubicmetre,andfallswithinalimitingrangeofOto-12.Intermediateconcentratiospecified,with0,1beingthesmallestpermitted3Licensee=UniversiyofAlberta/5966844001,User=sharabiani,shNotforRasale,12/02/201309N=log₁0[cx].0CopyrightItermationalOrganizLicensee=UniversityofAlberta/5966844001,User=sharabianiY03X₂airborneconcentratX₃airborneconcentration(ng/m3)performingspecifiedtestispecifieddocumentationoftheresultsandconditionsoftesting.Alternativemethodsofcomparableaccuracymaybespecifiedbyagreement.5Licensee=UniversiyofAlberta/5966844001,User=sharabianiNotforRasale,12/02/201309Itisrecommendedtocarryoutreplicatesamplia)nameofthetestoperator,thenameandaddressofthetesdurationofsampling;b)numberandyearofpublicationofthispartofISO14644,i.e.ISO14644-8:2013;c)clearidentificationofthephysicallocationofthecl(includingreferencetoadjacentareasifnecessary)andspecificdesid)specifieddesignationcriteriaforthecleanroomorconsubstancegrouporcategory(ies),theelapsedte)detailsofthetestprocedureused,withanyavailabledatadescribingthetestcircordeparturesfromthetestmethoLicensee=UniversiyofANoreproductionornetworkingpermittedwithoutlicensefromIHSA.2ConceptsforestablishingThefollowingprinciplespermittheestablishmentoftheparameterswhichinfluencetheACCora)First,establishiftheproductorprb)Establishthecontaminantcategoriesthataffecttheproductorprocessandifanyparticulargroupspermittedfortheproductorprocessanddesignateth2)constructionmater4)operationandmaintenanceofthefacility;5)personnel,cleanroomapparelandauxiliarymaterialofcompoundsorsubstancesaffectingtheproductorprocess.Inaddition,theconstructionmaterialsofNorepoductionornetwoerngermi7Licensee=UniversiyofAlberta/5966844001,User=sharabiani,shNotforRasale,12/02/201309A.3.2Theanalysisoftheconcentrationshouldbeconductedoveraperiodoftimesufficienttitsvariability,alongwithconsiderationofanyfuturedevelopA.3.3Insomecases,duetoprevailingwinds,proximityofcontaminatingsources,etc,chemicalcontaminationcontaminationlevelsfromthesamebuildingexhaust,exhaustfromneighbouricontaminationsourcesincludingfarms,sewerplants,dumps,highways,airpoofday,precipitation,temperamonitoringwherepossibledatesandwithsamplingformanyA.4.1ConstructionmaterialsservingthefacilitycanbesourcesofoutgassingA.4.2Thedegreeofmaterialoutgassingcanbedependentuponthetempressureofthecleanroomothedesignofthefacility.A.4.3Outgassingfrommaterialsofconstruasymptoticallyoveraperiodoftime.Thinnermatersolvents)tendtodecaymorerapidly,butthickermaterials(floortiles,insulation,ULPAfiltecompounds)andhigherboilingcompounds[plasticisers,antioxidants,organophoslargersilicones)candecaymuchmoreslowly,andpossiA.4.4AllmaterialsformingtheconstructionofafacilitywhereairchemicalcontaminationisA.5.1ChemicalcontaminaA.5.2ThedegreeofsuchcontaminationshouldbeassessedandevaluateA.5.3Insomecases,cross-contaminationctechnologytocontaintheserviceoA.5.4Asignificantsourceofoperations.Maintainingemissions,forexampleLicensee=UniversityofAlberta/5966844001,User=sharabiani—facemasksorventilated/filteredhelmets一qualifiedchemicalanalysisofgarments,glovesandpackag一qualifiedchemicalanalysisofanyproductpackagingmaterials,takingintocons—temporaryisolationbarriersforuseduringmaintenanceorrepairofmachineryorservices;一operativeprotocolsinstatedtominimizechemicalcontamiFortheareasmostsensitivetoairchemicalcontaminationeffects,pocontrolledairflowisrequired.Thisincludesensuringallexhaustlinesareundernegativepressurerelativeplenums,trenches,vents,hollo—useofcosmetics,deodorants,handlotions,soapsperfumesandha—practiceofsmoking;—useofmedication;—consumptionofcertainfoodsa—entryandexitprocedures;—personaluseofcleaninganddisinfectantm—consumables;—equipment;CopyrightnternationalOrganizafnto?Standardizailnrights9Licensee=UniversiyofAlberta/5966844001,User=sharabiani,shNotforRasale,12/02/201309—reactionby-products,especiallyfrometchingorchemicalvapourdeposition—heaters,insulation,computers,displays,printers,electro—leaksofchemicals,coolants,wastestreams,sewergases,antistatictreatments—sorptiononsuitablematerials(activatedcarbon,treatedactivatedcarbo—catalyticphotooxidation;NoreproductionornetworkLicense=UniversityofAlberta/5966844001,User=sharabianiNoforRasale,12/02/chemicalattributesthatfofcontaminatingchemicalsandcategoriestProvidedbyIHSunderlicProvidedbyIHSunderlicNoforRasale,12/02/Licensee=UniversityofAlberta/5966844001,User=shcopynightOrgarizatonlorStandardizationXXXXXXXXXXXXXXBHT:di(t-butyl)hydroxytolXXXXXXXXXXXXXXCyclopolydimethylsilXXXXXXXXXXXXXXXDi(2-ethylhexyl)phthXXXXXXXXXXDecamethylcyclopentasilXXDodecamethylcyclohexasilXXXXXXaac:acid;ba:base;bt:biotoxic;cd:condensable;cr:corrosive;dp:dopant;or:organic;oxH:Highlycondensable,boiliM:Moderatelycondensable,200℃≥Tb≥100℃;L:weaklycondensable,100℃>Tb(Tbistheboilingpoint)CopyrightInternationalOrganizationforXXXXXXXXXXXXXXXXXXXXXXXXXXXHexamethylcyclotrisiloXXXXXXXXXNitrogendioxideXXXXXXXXXXOctamethylcyclotetrasXXXXXXXXXXXXXXXXXXXTris(2-chloro-1-propyl)phoXXXXTris(1-chloro-2-propyl)phoXXXXXXXXXXaac:acid;ba:base;bt:biotoxic;cd:condensable;cr:corrosive;dp:dopant;or:organic;oxH:Highlycondensable,boilM:Moderatelycondensable,200℃≥Tb≥100℃;L:weaklycondensable,100℃>Tb(Tbistheboilingpoint)Tris(2,2,2-trichloroethyl)phoXXXTris(chloroethyl)phoXXXXTetramethylammoniumhydXXXXXXXXXXXXTotalsiloxanes,linXXXXTotalsiliconcompounds,orgaXXXXXXXXXXXXXTotalhydrocarbonderivaXXXXTotalnon-methanehydrocarbonderivaXXXXTotalunsaturatedhydrocarbonderivaCmHnOpXy(whereXisanyotherelemeXXXXaac:acid;ba:base;bt:biotoxic;cd:condensable;cr:corrosive;dp:dopant;or:organic;oH:Highlycondensable,boilingpoint>200℃;M:Moderatelycondensable,200℃≥Tb≥100℃;L:weaklycondensable,100℃>Tb(Tbistheboilingpoint)C.1.1Thisannexisintendedtogiveguidanceonthevariofchemicalcontamination,inconsiderationofthecompounC.1.2TheinstrumentsreferredtointhisannexarenotintenC.2.1Methodscanbebroadlydividedintotw—methodsofdirectanalysis,includingo—methodswherethesamplecollectionisseparateorevormoregascomponent(s).Thismethodrequiresextendwithinareducedtimeperiod.Activesamplinginstrumentscaninvolvecomasuitableadsorbent,e.g.Tenax¹),activatedcharcoacoatedfilter,impregnatedwithasuitablechemic—impinger(IMP),comprisingasingleorseriesofgas-washingbottlesfilledwithdsamplebag(SB),foruseathighconcentrationsofairchemicalcontaminatNorepoductionornetwoerngermiLicensee=UniversityofAlberta/5966844001,User=sharabianibag,reactionsbetweenanalytes,andcarryoverfromprevioussamples.ThismethodisnotasusefulThesecaninclude,but—samplebag(SB),canister/container(CAN)fo—diffusiontube(DT).Thesecaninclude,but—atomicemissionspectroscopy—Massgaindetection(MGD)withresonatorsincludingquartzcrystalmicrobalan—gaschromatography-mCopyrightIntermationalOrganizaProvidedbyIHSunderlicensNoreproducionornetworLicensee=UniversiyofAlberta/5966844001,User=sharabiani,sh—infraredspectroscopy(IR);—totalreflectionX-rayfl—vapourphasedecomposition-totalreflectionX-ra—timeofflight-secondaryionmass—atmosphericpressureionization-Thesecaninclude,but—colourimetricdetectiononchemicallyimpregnatedpape—massgaindetector(MGD)[ofcondensedorganicbuild-up]usingdifferenttypesofpiezoelec—sensorsofelectrochemica—chemiluminescencemonitorin—surfaceacousticwave—cavityringdownspectroscopCopyrghtrternationaOraizatonto?StandardzailnrNoreproductionornetworkNoforRasale,12/02/ClassN0DIFFDIFFIR,CLS,CPR,FID,NOTEMethodscorresNoreproductionornetworkNotforRasale,12/02/D.1.1ThisannexisintendedtogiveguidanembodyspecialdesignfeaturesthatrequireconsiderationwhenclassifyingtotherequirD.1.2ConsiderationshouldbegiventothepossibilityInsomecases,wherenodirectmeasurementoftheACCispossible(measurementsofthesurfacecleanlinessbychemicalconcentrationaretheonlypossiblewayofcharacterizingthedegrNOTETherelationbetweenD.2SpecificconD.2.1ThedesignofthebarriertechnologyemployedcanrestrictchoicesinthemethodofsD.2.2Thematerialsuswithflexiblegloves,bagsormanipulativedevices.ThesemateD.2.3AnyretrofittedmaterialsorextensionstothedeviceandtheirpotentialsourcescontaminationshouldbeD.2.4Wheretheproductisofparticularconcern,itmaybedecidedtoverifytheperformanceofthedevicebyaprocessofmeasurementandanalWhereverificationisperperiodinwhichtheproductremainsinthedevicecanbeamajorinfluencingfactorandshouldbeconsidered.D.2.5Pumpedsamplingofsmallenclsignificantlydilutetheairche