【astm標準】e 2352 - 04 (2010)

1、Designation:E2352?04(Reapproved2010)StardPracticefAerospaceCleanroomsAssociatedControlledEnvironments—CleanroomOperations1ThisstardisissuedunderthefixeddesignationE2352thenumberimmediatelyfollowingthedesignationindicates

2、theyearofiginaladoptioninthecaseofrevisiontheyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperepsilon()indicatesaneditialchangesincethelastrevisionreapproval.1.Scope1.1Thispracticespecifiesba

3、sicrequirementsprocedurespracticesfoperatingaerospacecleanroomscontrolledenvironmentsprecautionsassociatedwiththefacilityequipmentused.1.2Thisstarddoesnotpurpttoaddressallofthesafetyconcernsifanyassociatedwithitsuse.Itis

4、theresponsibilityoftheuserofthisstardtoestablishappropriatesafetyhealthpracticesdeterminetheapplicabilityofregulatylimitationspritouse.2.ReferencedDocuments2.1ASTMStards:2D737TestMethodfAirPermeabilityofTextileFabricsE59

5、5TestMethodfTotalMassLossCollectedVolatileCondensableMaterialsfromOutgassinginaVacuumEnvironmentE1216PracticefSamplingfParticulateContaminationbyTapeLiftE1234PracticefHlingTransptingInstallingNonvolatileResidue(NVR)Sampl

6、ePlatesUsedinEnvironmentallyControlledAreasfSpacecraftE1235TestMethodfGravimetricDeterminationofNonvolatileResidue(NVR)inEnvironmentallyControlledAreasfSpacecraftE1549SpecificationfESDControlledGarmentsRequiredinCleanroo

7、msControlledEnvironmentsfSpacecraftfNonHazardousHazardousOperationsE1559TestMethodfContaminationOutgassingacteristicsofSpacecraftMaterialsE1560TestMethodfGravimetricDeterminationofNonvolatileResidueFromCleanroomWipersE17

8、31TestMethodfGravimetricDeterminationofNonvolatileResiduefromCleanroomGlovesE2042PracticefCleaningMaintainingControlledAreasCleanRoomsE2088PracticefingPreparingExposingAnalyzingWitnessSurfacesfMeasuringParticleDeposition

9、inCleanroomsAssociatedControlledEnvironmentsE2217PracticefDesignConstructionofAerospaceCleanroomsContaminationControlledAreasF25TestMethodfSizingCountingAirbneParticulateContaminationinCleanroomsOtherDustControlledAreasF

10、50PracticefContinuousSizingCountingofAirbneParticlesinDustControlledAreasCleanRoomsUsingInstrumentsCapableofDetectingSingleSubMicrometreLargerParticlesF51TestMethodfSizingCountingParticulateContaminantInOnCleanRoomGarmen

11、tsF318PracticefSamplingAirbneParticulateContaminationinCleanroomsfHlingAerospaceFluids2.2GovernmentStards:3FederalStard209EAirbneParticulateCleanlinessClassesinCleanroomCleanZones(cancelledNov.292001)NASASTD6001Test#7Fla

12、mmabilityOdOffgassingCompatibilityRequirementsTestProceduresfMaterialsinEnvironmentsThatSupptCombustion2.3OtherTechnicalSocietyStards:IESTRPCC003GarmentsRequiredinCleanroomsControlledEnvironments4IESTRPCC004EvaluatingWip

13、ingMaterialsUsedinCleanroomsOtherControlledEnvironments4IESTRPCC005CleanroomGlovesFingerCots4IESTRPCC018CleanroomHousekeeping—OperatingMonitingProcedures41ThispracticeisunderthejurisdictionofASTMCommitteeE21onSpaceSimula

14、tionApplicationsofSpaceTechnologyisthedirectresponsibilityofSubcommitteeE21.05onContamination.CurrenteditionapprovedApril12010.PublishedMay2010.iginallyapprovedin2004.Lastpreviouseditionapprovedin2004asE2352–04.DOI:10.15

15、20E235204R10.2FreferencedASTMstardsvisittheASTMwebsitewww.astm.gcontactASTMCustomerServiceat.FAnnualBookofASTMStardsvolumeinfmationrefertothestard’sDocumentSummarypageontheASTMwebsite.3AvailablefromU.S.GovernmentPrinting

16、OfficeSuperintendentofDocuments732N.CapitolSt.NWMailStop:SDEWashingtonDC20401.4AvailablefromInstituteofEnvironmentalSciencesTechnology(IEST)ArlingtonPlaceOne2340S.ArlingtonHeightsRd.Suite100ArlingtonHeightsIL600054516:ww

17、w.iest.g.Copyright?ASTMInternational100BarrHarbDrivePOBoxC700WestConshohockenPA194282959.UnitedStates14.1.2.1Table1givestherecommendedaircleanlinessclasspersonnelpracticesoperationalcontrolsfdifferenttypesofcleanroomcont

18、rolledareaoperations.Examplesofmethodsusedfdeterminingmanagingthesefactsinclude:(1)HAZOP(HACCPPrinciplesApplicationsperHACCPPrinciplesApplications)10(2)HACCP(HazardAnalysisCriticalControlPoint)(3)FMEA(FailureModeEffectsA

19、nalysis)perCEIIIEC1025FMEA:FailureModesEffectAnalysis11FailureModeEffectAnalysis:FMEAfromTheytoExecution1213(4)FTA(FaultTreeAnalysis)perEN11491(5)Evaluationofsensitivityoftheproductsequipmentinthecleanroomcontrolledareat

20、otheeffectsofcontaminationtheeasecostofcleaningthoseproductsremovingcontaminationproducts.4.1.3Asystemftrainingcertifyingpersonnelincleanroomproceduresisrequired.Provideamethodfmonitingcompliancetoprocedures.Allpersonnel

21、mustbetrainedcertifiedwithregardtotheirresponsibilitieshowthoseresponsibilitiesaffectthecleanenvironment.Personnelshallberecertifiedeverytwoyears.Thetrainingshouldensurethateachofthefollowinggroupsofpersonneliseducatedtr

22、ainedappropriately:operatstechniciansengineersscientistssupervissmanagersfacilitiespersonnelcontractsfieldservicepersonnelvisits.4.1.3.1Recdsshallbemaintainedtoprovideevidencethatallpersonnelhavereceivedpropertrainingint

23、hefollowingareas:(1)Howthecleanroomwks(designairflowequipmentusedairfiltration)(2)Cleanroomstards(3)Sourcesofcontaminationhowtoavoidcontrolthem(4)Hygienepermittedprohibitedpersonalcareproducts(5)Cleaningoperationshlingof

24、products(6)Cleanroomclothingchangingprocedures(7)Maintenanceprocedures(8)Cleanroomtestingmoniting(9)Properbehaviinacleanroom(10)Wkprocessestechnologiesemployed(11)Safetyemergencyresponses(12)Crectiveactionsifthereareoper

25、ationalfailuressuchasexceedingallowedparticlecountstemperature.4.1.3.2Differenttypesofpersonnelrequiretrainingindifferentareas.Fexamplevisitsneednotbetrainedinmaintenancetestingmonitingcrectiveactions.Failuretoproperlytr

26、ainanyoneenteringusingmaintainingthefacilitywillcompromisetheeffectivenessofthecleanroom.4.1.4Coursestakenpassedfcertificationmustbeidentified.Aconcisecomprehensivesystemthatdocumentsthetrainingprogressionlevelofeachindi

27、vidualshouldbeused.Eachjobsetofjobsresponsibilitiesshouldbeidentifiedbythemanagementteam.Thissystemshouldbeeasilyaccessibletomanagementperiodicallyreviewed.Basicdocumentationshouldincludecoursecontentspersonnelidentifica

28、tioninfmationtrainingcertificationdatesschedulesfretrainingatfutureintervals.4.1.5Asetofproceduresshallbedocumentedtodescribehowthecleanroomsystemsaretobeoperatedmaintainedrepairedmonited.SeeISO14644—Part4.Factsthatmayin

29、fluencetheoperationenvironmentalqualityofthecleanroommayincludethefollowing:4.1.5.1Entryexitmovementproceduresfequipmentpersonnel4.1.5.2Installationofequipment4.1.5.3Cleaningtechniquesmethodology4.1.5.4Contaminationgener

30、ationfrompersonnelequipmentoperation4.1.5.5Generationofheathuityelectrostaticge4.1.5.6Servicemaintenancerepairofequipmentfacilities4.1.5.7Cleanlinessofprocessmaterialsutilitiesdeliverysystems4.1.5.8Testingmonitingthefaci

31、lity4.1.5.9Routineenvironmentalcontaminatingfacts(airflowsairbneparticlesoutgassinghazardousgasvibrationelectrostaticgesmolecularcontamination)4.1.5.10Personnelmaterialflow4.1.5.11Emergencyplannedshutdowns4.1.5.12Facilit

32、yexpansionmodification4.1.5.13Frequencyofmonitingtheresults10HACCPPrinciplesApplicationseditedbyMerleD.PiersonDonaldA.ClettJr.Chapman&HallNewYkNY1992.11PaladyP.FMEA:FailureModesEffectAnalysisPTPublicationsInc.WestPalmBea

33、chFL1995.12StamatisD.H.FailureModeEffectAnalysis:FMEAfromTheytoExecutionAmericanSocietyfQualityMilwaukeeWI1995.13KletzT.A.HazopHazan:IdentifyingAssessingProcessIndustryHazardsHemispherePubWashingtonDC1992.TABLE1MinimumRe

34、quirementsfAirCleanlinessClassesOperationsConstraintsOperationControlsClass4Class5Class6Class7Class8Class8.5WeargarmentsincludinghairbeardcoversRequiredRequiredRequiredRequiredRequiredNobeardhaircoversEnterviaanteroomwit

35、hairshowerairlockRequiredRequiredRequiredOptionalOptionalNoNocosmeticssimilarproductswnRequiredRequiredRequiredRequiredRequiredNoSinggrindingmachiningprohibitedRequiredRequiredRequiredControlledControlledControlledPartic

36、lecountstakencontinuouslyRequiredRequiredRequiredRequiredOpt.WeeklyTemperaturehuityrecdedcontinuouslyRequiredRequiredRequiredRequiredOpt.DailyWearglovesevenwhennothlingproductsRequiredRequiredRequiredRequiredOpt.Opt.Prec

37、leanallequipmentbefeentryverifycleanRequiredRequiredRequiredRequiredReq.Opt.CleanwkingsurfacestwicedailyRequiredRequiredRequiredRequiredDailyNoRemovetrashwastedailyRequiredRequiredRequiredRequiredPreferredNoPersonneltrai