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f)UsingairsupplyrateforcalculationsofcontaminantdilutionandremovalProductsandprocessesthatbenefitfromthecontrolofairbornecontaminationinclude thoseinsuchindustriesasaerospace,microelectronics,pharmaceuticals,medicaldevicesandhealthcare.ThisInternationalStandardalsoprovidesguidanceonthe basicelementsofdesignandSpecifiesamethodologytoassessthesuitabilityofequipmentforuseincleanroomsandassociatedcontrolledenvironmentsItapplies tonew,refurbishedandmodifiedcleanroominstallationsProductsandprocessesthatbenefitfromthecontrolofairborneThisdocumentspecifiestheprocessfor creatingacleanroomfromrequirementsthroughtoitsdesign,constructionandstart-upTheworkofThisdocumentspecifiestheprocessforcreatingacleanroom fromrequirementsthroughtoitsdesign,constructionandstart-upItdoesnotprescribespecifictechnologicalorcontractualmeansofachievingtheserequirements ISOspecifiesthedesign,construction,andstart-uprequirementsforcreatingacleanroombyprovidingdetailedcheckliststhatincludeimportantperformance parameterstobeconsidered.Thisstandardpertainstonew,refurbished,andmodifiedcleanroominstallationsCleanroomsandassociatedcontrolled environmentsPartDesign,constructionandstart-up,specifiesrequirementsforthedesignandconstructionofcleanroomandcleanairdevices,aswellas requirementsforstart-upandqualificationFileOpenisafreepluginwhichiscompatiblewithAdobeAcrobatReaderDCandProDC,aswellasotherPDF ReadersISOCleanroomsandassociatedcontrolledenvironments PartDesign,constructionandstart-upItappliestonew,refurbishedandmodifiedcleanroom installationsThisrevisionfocusesontheimportanceofventilationeffectivenessthroughcontrolofair-flowpatternsandclean-uprecoveryratesThisdocumenthas beencreatedbyKleanlabs,aEuropeanmanufacturerofcleanroomThedocumentwassubmittedasanAmericanNationalStandardandhasbeenadoptedas ANSI/IEST/ISOintheUnitedStatesScopeofISOThisToviewthePDF,aDRMtool,FileOpenmustbeinstalledTwomeasuresareidentified:airchange effectiveness(ACE)andcontaminantremovaleffectiveness(CRE).roomwithinwhichthenumberconcentrationofairborneparticlesiscontrolledandclassified, andwhichisdesigned,constructedandoperatedinamannertocontroltheISO(E)ForewordISO(theInternationalOrganizationforStandardization)isa worldwidefederationofnationalstandardsbodies(ISOmemberbodies)ThisdocumentspecifiestheprocessforcreatingaISOTherevisedversionofthispart ofaddressesthe≥ISOµmparticlelimitsforISOClassinthesterileproductsannexesoftheEU,andWHOGMPsINTERNATIONALSTANDARDISO(E) Cleanroomsandassociatedcontrolledenvironments PartDesign,constructionandstart-upScopeThisdocumentspecifiestheprocessforcreatingacleanroom fromrequirementsthroughtoitsdesign,constructionandstart-upThispartofISOspecifiestherequirementsforthedesignandconstructionofcleanroomfacilities ISO(E)IntroductionCleanroomsandassociatedcontrolledenvironmentsprovideforthecontrolofairborneparticulatecontaminationand,ifrelevant,otherforms ofcontamination,tolevelsappropriateforaccomplishingcontamination-sensitiveactivities.Providesrequirementsandguidanceforassessingthechemicalairborne cleanlinessofequipmentandmaterials,whichareforeseentobeusedincleanroomsandassociatedcontrolledenvironmentsItappliestonew,refurbishedand modifiedISOCLEANROOMSTANDARDFreeDownloadTHECOMPLETEGUIDE