TEB-APR-STP-0059

UncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyApprovals:FirstLevelSecondLevelThirdLevelFourthLevelNationalInstituteforOccupationalSafetyandHealthNationalPersonalProtectiveTechnologyLaboratoryP.O.Box18070Pittsburgh,PA15236ProcedureNo.TEB-APR-STP-0059Revision:2.1Date:27August2012DETERMINATIONOFPARTICULATEFILTEREFFICIENCYLEVELFORN95SERIESFILTERSAGAINSTSOLIDPARTICULATESFORNON-POWERED,AIR-PURIFYINGRESPIRATORSSTANDARDTESTINGPROCEDURE(STP)1.PURPOSEThistestestablishestheprocedureforensuringthatthelevelofprotectiondeterminedbytheparticulatefilterefficiencyleveltestforN95seriesfiltersusedonnon-poweredrespiratorssubmittedforApproval,ExtensionofApproval,orexaminedduringCertifiedProductAuditsmeettheminimumcertificationstandardssetforthin42CFR,Part84,SubpartG,Section84.181.Thesefiltersandfiltercartridgesmaybeintegralcomponents;mountedindividually;usedinconjunctionwithcartridgesandcanistersforchin-style,front-mounted,andback-mountedgasmasks;orusedincombinationwithgas-and-vapororsupplied-airrespirators.2.GENERALThisSTPdescribestheDeterminationofParticulateFilterEfficiencyLevelforN95SeriesFiltersAgainstSolidParticulatesForNon-Powered,Air-PurifyingRespiratorstestinsufficientdetailthatapersonknowledgeableintheappropriatetechnicalfieldcanconductthetestanddeterminewhetherornottheproductpassesthetest.3.EQUIPMENT/MATERIAL3.1.Thelistofnecessarytestequipmentandmaterialsfollows:3.1.1.TSIModel8130AutomatedFilterTesterorequivalentinstrument.Airflowcontrolaccuracyis2%offullscale.Pressuremeasurementaccuracyis2%offullscale.Penetrationscanbemeasuredto0.001%,efficienciesto99.999%.3.1.2.Microbalanceaccurateto0.0001grams(g).UncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyProcedureNo.TEB-APR-STP-0059Revision:2.1Date:27August2012Page2of113.1.3.TypeA/Eglassfilters,102mmdiameter,highefficiencyfilterswitha1micronporesize.3.1.4.Timer(accurateto0.01second).3.1.5.2%sodiumchloridesolutionindistilledwater(NaCl).3.1.6.Temperatureandhumiditychambercapableofmaintaining38±2.5°Cand85±5%relativehumidity.3.1.7.RespiratorfilterholdersuppliedforspecificmanufacturertypewhichiscompatiblewithTSIfiltertester.NIOSHwillnotbeobligatedtousetheseholdersforactualcertificationtesting.AllmanufacturertestfixturesmustbecorrelatedwiththeNIOSHtestmethod.3.1.8.Thermalprinter(supplied)oroptionaldataacquisitionsystem.3.1.9.TSI,GreenLinePaper,partnumber813010.Lotnumbermustbeincludedoneachbox.Eachlotnumbermustincludethe“Penetrationvs.Resistancegraph”.3.2.RefertothefollowingWorkInstructionsforfurtherinformationonperformingthistest:TEB-SOPWI-0004WorkInstructionsfortheSetupoftheTSI8130FilterTestersforSalt(NaCl)4.TESTINGREQUIREMENTSANDCONDITIONS4.1.Priortobeginninganytesting,allmeasuringequipmenttobeusedmusthavebeencalibratedinaccordancewiththetestinglaboratory’scalibrationprocedureandschedule.AllmeasuringequipmentutilizedforthistestingmusthavebeencalibratedusingamethodtraceabletotheNationalInstituteofStandardsandTechnology(NIST)whenavailable.4.2.AnylaboratoryusingthisproceduretosupplycertificationtestdataasacontractortoNIOSHwillbesubjecttotheprovisionsoftheNIOSHSupplierQualificationProgramUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyUncontrolledCopyProcedureNo.TEB-APR-STP-0059Revision:2.1Date:27August2012Page3of11(SQP).ThisprogramisbasedonthetenetsofISO/IEC17025,theNIOSHManualofAnalyticalMethodsandotherNIOSHguidelines.Aninitialcompletequalitysystemauditandfollowonauditsarerequirementsoftheprogram.AdditionaldetailsoftheProgramanditsrequirementscanbeobtaineddirectlyfromtheInstitute.**Note4.2doesnotapplytoPretestdatafromapplicantsasrequiredunder42CFR84.64.4.3.Precisionandaccuracy(P&A)mustbedeterminedforeachinstrumentinaccordancewithlaboratoryproceduresandNIOSH/NPPTLguidance.Soundpracticerequires,underNIOSHManualofAnalyticalMethods,demonstratingatolerancerangeofexpecteddataperformanceofaplusorminus25%ofa95%confidenceintervalofthestatedstandardrequirement.NIOSH/NPPTLP&Atolerancecanbehigherbutnotlower.4.4.Theprecisionandaccuracyofthismethodismonitoredbythevalidationmethodwhichisincorporatedintheautomatedfiltertesterprocedure.Thisprocedureisperformedonadailybasiswhentestingisperformed.Thisprocedureisdesignedtotestmanyaspectsofthemethod,forproperphotometerandgeneralsystemoperation.Thevalidationtechniqueuses“greenline”filtermediadiscs,6inchdiameter,HE1071grade,H&Vbrand,P/N813010,withaknownpenetrationrange,whicharetestedatleastonceineach8hourtestperiod(see5.2.5).4.4.1.Twosheetsofunusedfiltermediaarestackedtogetherandthepenetration,flowrateandpressuredroparemeasuredtoevaluatethehigherrangeofpenetrationvalues.Fiveunusedsheetsarestackedtogethertoevaluatethelowerrangeofpenetrationvalues.4.4.2.Theanalysisofthesereadingsoverthelongtermwasusedtoexaminetheprecisionandaccuracyofthistestmethod.Thetablebelowsummarizesthedata.TwoSheetsFiveSheetsMean2.692%0.033%Std.Dev.0.3180.007Ra