ISO 27427-2023.docx

.9Rationa1.efortype-testmethods,representativesamp1.es(4.2.1.1)VariabiIityRationaIefpartic1.especifcations4.2.1.2)a1.sobebeneficia1.SeeISO20072:2009,6.1.Theprovidesodiumcomparab1.eoutcomes.A1.butero1.(a1.sosubstancerecommendeddifficu1.tconsidereddrugFDAdasses：beta-agonistbronchodi1.ators,anticho1.inergicbronchodi1.ators,steroids,antia1.1.crgics,c11)mo!ynRationaIe(anti-inf1.ammatory)testmethdS(4.2.2)Variousmethodsforpresentingaeroso1.outputandpartic1.esizedistributionofnebu1.izersareinuse(seeA.12Rationa1.eforsma1.1.-boreconnectors6.2.1d)connectorsappUcadonsapp1.icaUons：PreV1.oUSIyUscdpressureconncctorssuch1.SOHreathingindudestwoconnectorattherespiratorytbing.connectors,ISO17256,dnvenmandatedusi11conerespiratoryA.13Rationa1.eformaximumtemperatureofthe1.iquidcontainer9.3.1b)ingredients,suchnebu1.izedproteinsorDNAcomponents,canbesensitivetotemperatureandA.14Rationa1.efora1.ternativetestmethods9.3.2k)assessment,chTomatographymethodshavespectrophotometr),againstcanBecascadeimpactionrepeatedperformance.15Rationa1.eforsoundpressure1.eve1.s9.3.2m)A.16Rationa1.efortestprincip1.eC.1.(MnRtt.i1.Disrta辆hhimCb1.s"UiMrfi2venwh1.nibuqy1.ijn)t1.erhQJcQm"WtejvfstHcipaticntoutif1.1.hdesnebu1.izerand1.ost.Thusron1.yacertainfractionofaeroso1.producedbythenebu1.izercanbetakenupbythepatient.ThetestdescribedinthisC1.auseco1.1.ectstheaeroso1.exitingatthenebu1.izermouthpieceRWM“/izern摘SUr“蛤耐dv8h睢轴郴洲密蚓睡m1f1.器SSexp强然般既鸦IbuterO1.iSrateinmi1.1.i1.itresoftestso1.ution0,1%(mmorVV)perminute.17Rationa1.efortestconditionsC.2Thecommitteechosetheseconditionstorepresenttheconditionsaffectingthemajorityofgenera1.tmht11ManmJP1.1.Ctfmtreyre)resenthUmKtyfonCtnebu1.izersWiH1.in1.feHiOttawce.systems,wherehigherA.18Rationa1.efortestequipcmentC3Abreathingsimu1.atorisusedwhendeterminingtheaeroso1.outputfromanebu1.izerinordertoth京刖iEUhdgirifmdatedaecoHumeegaibeIPhhm用ini而对IgFedimtrPio翻ed"x)Mttetwi(tefpatientpopu1.ations,Itcou1.dbeusefu1.toana1.ysemu1.tip1.ebreathingpatternsassociatedwithdifferentpatientopu1.ations(26.19Rationa1.efortestmethodC,4Measurementsofmassratherthanvo1.umea1.onecorrectforevaporative1.osses.A.20Rationa1.efortestprincip1.eD,1.Acontinuoussuctionpumpisusedfornebu1.izedaeroso1.sizetestingbecauseimpactorsforperformingthesemeasurementsneedtooperateataconstant"inha1.ation"owratetoreasonab1.yestimateaeroso1.size.14AnnexB(informative)Diametersofrespirab1.efractionpartic1.esIngenera1.itisconsideredthataeroso1.partic1.eswithanaerodynamicdiameterof >5marcdepositedintheupperairways, 2mto5maredepositedintheIowpcairways,and <2maredepositedinthea1.veo1.i(27)(2s).战蹄圈汜拙粕ardsizingd渊酷监ned6K“源思C揄”。5三o1.at<限而阳欣钿田服喃肺小功SiZedistributioncurveasfo1.1.ows.MMAD:Notethepartic1.esizeatwhichthe1.inecrossesthe50%mark.GSD:Thisshou1.dbeca1.cu1.atedon1.yifthepartic1.esizedistributioncurveisreasonab1.ystraightbetween10%and90%,showingthattheaeroso1.is1.og-norma1.1.ydistributed.Whereastraight1.ineisagoodfit箱d49¾(m船rk<W1.AB白肝sifeVfbKrthU1.W由怛CroS咫岛3g8F5whichthe1.inecrossesThenrtheGSD=(XY)<,s.MS,Sst11ft?vingthatarebasedoninterpo1.ationfromagraphareinevitab1.yRigorousmathematica1.methodsofana1.ysisaredescribedinISO9276-1andISO9276-2.Thesemethodsarereadi1.yperformedbyacomputer,inc1.udingthegenerationofthepartic1.esizedistributiongraph.AnnexD(normative)Testmethodsforpartic1.esizingD.1.Testprincip1.eThenebu1.izingsystemistestedforpartic1.esizebycapturingtheaeroso1.outputinacascadeimpactordrivenbyairandana1.ysingtheresu1.ts.Twodifferentsetsoftestequipmentandtestmethodsaredescribedthata1.1.owtheuseofeither ahigh-owcascadeimpactor(ca1.ibratedat151.m),or a1.ow-f1.owcascadeimpactor(ca1.ibratedatf1.ows1.essthan151.m).忡e挪HJ箱beth珈hf%hteta柚0se布MP姗解将蛊册ie'h曲掂i删删税中做部器c1.easi和限桁r,Testconditions,ca1.cu1.ations,andexpressionsoftestresu1.tsareotherwiseidentica1.betweenthetwomethods.NOTE(NGwi),Severa1.typesofcascadeimpactorsarcavai1.ab1.e(c.g.Marp)c,Andcrson,andNextGenerationImpactorD.2Testconditionsfora1.1.testmethodsTheambienttestconditionsfora1.1.testssha1.1.be: temperature:(23±2)； re1.ativehumidity:45%to75%;D.3解系e(i8Wyftte1.ftftt>rca1.ibratedandoperatingat151/min .3.1TestequipmentThetestequipment(seetheschematicdiagraminFigure1).1)prise:a) thenebu1.izingsystemundertest;b) acascadeimpactor:1) withat1.easteightstagestoestimatetherespirab1.efraction;2) withSufTiden1.1.oadingcapacityoneachstagetoestimatetherespirab1.efractionwithoutover1.oadinganystage；3) withnomeasurab1.eheattransfer-re1.ateddrop1.etevaporation;NoTE1THErnpactorcanbechi1.1.edtoavoidthiscauseofinaccuracy.1)NGImisIhecrademarkofaproductsupp1.iedbyMSPCorporation,Shoreview,MN,USA.Thisinformationisgiven61.SICnkwiftQ4fitftn9y稳也adftft帮r1.冷t小部。蜘4ot(fiCIHfdcndorsCnWrnbyISOoftheproductnamed.19©ISO2023-A1.1.rightsreservedh3a31.Rft1.idiff1.nountahik)cchtscasDd1.tn