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潔凈室及相關(guān)受控環(huán)境第8部分:按化學(xué)物濃度劃分空氣潔凈度(ACC)等級(jí)Part8:Classificationofaircleanlinessbychemicalcon國家標(biāo)準(zhǔn)化管理委員會(huì)國家市場監(jiān)督管理總局發(fā)布國家標(biāo)準(zhǔn)化管理委員會(huì) I 3 5附錄A(資料性)影響ACC的因素 6附錄B(資料性)常見污染物 9附錄C(資料性)常用測量方法 附錄D(資料性)隔離裝置的特殊要求 第3部分:檢測方法:本文件代替GB/T25915.8—2010《潔凈室及相關(guān)受控環(huán)境第8部分:空氣分子污染分級(jí)》,與表B.1);ⅢGB/T25915.8—2021/ISO1——附錄B:常見污染物;——附錄C:常用測量方法;本文件是有關(guān)潔凈室及相關(guān)受控環(huán)境的GB/T25915的1個(gè)部分,除ACC外,潔的其他國家標(biāo)準(zhǔn)中。要特別注意GB/T25915的所有部分。有些情況下,相關(guān)管理機(jī)構(gòu)可能會(huì)規(guī)定某1GB/T25915.8—2021/ISO1本文件目前只考慮潔凈室運(yùn)行工況下空氣中10°g/m3~10-12g/m3GB/T25915.6潔凈室及相關(guān)受控環(huán)境第6部分:詞匯(GB/T25915—2010,ISO14644-6:GB/T25915.6界定的以及下列術(shù)語和定義適用于本文件。2GB/T25915.8—2021/ISO13GB/T25915.8—2021/ISO1種污染物或某組污染物的最大允許濃度。常見污染物見附錄B?!裆锒舅?bt);●可凝聚物(cd);●總有機(jī)化合物(toc);N=log??[cx]。表1和圖1給出污染物濃度與ISO-ACC等級(jí)的對(duì)應(yīng)關(guān)系。ISO-ACC等級(jí)04ACC等級(jí)GB/T25915.8—2021/ISO1ACC等級(jí)ISO-ACC等級(jí)圖1空氣中化學(xué)物濃度與ISO-ACC等級(jí)的對(duì)應(yīng)關(guān)系5應(yīng)記錄每個(gè)潔凈室或相關(guān)受控環(huán)境的檢測結(jié)果并提交綜合性報(bào)告,報(bào)告中應(yīng)寫明與規(guī)定的c)被測潔凈室或受控環(huán)境的具體位置(必要時(shí)以相鄰區(qū)域6本附錄給出潔凈室及相關(guān)受控環(huán)境內(nèi)影響或造成ACC的各種因素,這些因素在工程設(shè)計(jì)初始階1)室外空氣(向設(shè)施提供新風(fēng));2)設(shè)施內(nèi)的建筑材料,特別是接觸循環(huán)風(fēng)和新風(fēng)的材料;3)設(shè)施內(nèi)可能發(fā)生的交叉污染;4)設(shè)施的運(yùn)行和維護(hù);5)人員、潔凈工作服和輔助材料;6)工藝介質(zhì)和工器具。對(duì)這些情況的進(jìn)一步說明見A.3~A.8。e)為防止或減少由d)所列因素產(chǎn)生的化學(xué)污染,確定相應(yīng)的設(shè)計(jì)要求,以達(dá)到產(chǎn)品或工藝所需7GB/T25915.4—2010的附錄E給出了一些潔凈室適用建筑材料示例。A.4.3在許多情況下,建筑材料的釋出氣體可在一個(gè)時(shí)間段呈指數(shù)大程度地減少或防止交叉污染。GB/T25915.4—2010中附錄A和GB/T25915.7給出了這樣的示例。A.7人員-—個(gè)人對(duì)清潔和消毒材料的使用。89GB/T25915.8—2021/ISO1(資料性)關(guān)注的具體化合物對(duì)潔凈室環(huán)境內(nèi)生產(chǎn)的最終產(chǎn)品的有害化學(xué)反應(yīng),對(duì)污染物進(jìn)行分類。表B.1給出能影響產(chǎn)品或工藝的常見化學(xué)污染物和污染物類別。用戶可CAS登記號(hào)物質(zhì)污染物類別“HML氨氯XXx××XXXXXXXXXBHT:2(t-乙酸丁脂)鄰苯二甲酸丁芐酯(BBP)氧化硼XXXXXXXXXXXESi(CH?)?O子XXXXXX己二酸二(乙基己基)酯鄰苯二甲酸二癸酯十甲基環(huán)五硅氧烷ESi(CH?)2O子?ESi(CH?)20子。XXXXXXXXXXX×XXXxXXxXXX×X×XX××X表B.1能影響產(chǎn)品或工藝的常見化學(xué)污染物示例及其分類(續(xù))CAS登記號(hào)物質(zhì)污染物類別“HML×XX己醛ESi(CH?)2O子3XX×xXXXXXXXXXXXXX×X×XXXX×X—(NCH?)(C=O)(CH?)?一×××X××X×X××ESi(CH?)?O子4XXXX×XX×XXXXX磷酸三(1-氯-2-丙基)酯四甲基氫氧化銨XXXX×X×X×X×××XXX××XXX×XX×XXXX×XXXXESi(CH?)2O子。(X為任意元素)X×××XXXXX×X×X××XX×XXXXXGB/T25915.8—2021/ISO1表B.1能影響產(chǎn)品或工藝的常見化學(xué)污染物示例及其分類(續(xù))物質(zhì)污染物類別HML總非甲烷烴衍生物總非飽和烴衍生物(X為任意元素)XXXXXXXXH:高凝性,沸點(diǎn)>200℃;M:中凝性,200℃≥T?≥100℃;L:低凝性,100℃>T?(Tb為沸點(diǎn))。GB/T25915.8—2021/ISO1(資料性)C.1.1本附錄給出了化學(xué)污染化合物及其預(yù)期濃度C.2.4無源擴(kuò)散采樣器(DIFF)利用特別制備的表面,選擇性地收集一種或數(shù)種氣體成分。這種方法對(duì)低濃度ACC,需要較長的采樣時(shí)間。C.2.5有源采樣器是將確定量的空氣抽取通過吸附介質(zhì)所進(jìn)行的污染物采樣。這種技術(shù)能在較短的 -—離子色譜監(jiān)測系統(tǒng)(ICS);GB/T25915.8—2021/ISO1用戶宜注意檢出限并保持在其范圍內(nèi)?;厥章室嗽?5%~125%。上述測量方法列于表C.1。等級(jí)污染物類別酸堿0SB,GC-FID,注:表中縮寫所代表的方法見C.3。要考慮到這些特點(diǎn)。本附錄意在為這些隔離裝置提供指導(dǎo)。隔離裝置的各種類型和應(yīng)用見D.1.2宜考慮隔離裝置本身造成污染的可能性。有些場合無法直接測量ACC(例如,量太低),此時(shí),確定污染程度的唯一方法是測量表面化學(xué)物D.2.1屏障技術(shù)限制著ACC采樣方法和分析方法的選擇。需方和供方宜通過協(xié)商確定最佳檢測方D.2.2宜按附錄A的說明選擇制造隔離裝置的D.2.4需要對(duì)產(chǎn)品給予特別關(guān)注的場合,可通過測量和分析產(chǎn)品的表面化學(xué)污染來驗(yàn)證裝置的性能(見D.1.2)。D.2.7為控制空氣化學(xué)污染,特定的行業(yè)能有特定的推薦性檢測方法或檢測技術(shù)要求,或檢測指南。[2]GB/T25915.5潔凈室及相關(guān)受控環(huán)境第5部分:運(yùn)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=log?0[cx].0CopyrightItermationalOrganizLicensee=UniversityofAlberta/5966844001,User=sharabianiY03X?airborneconcentratX?airborneconcentration(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
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