ISO 27427-2023.docx

《ISO 27427-2023.docx》由会员分享，可在线阅读，更多相关《ISO 27427-2023.docx（14页珍藏版）》请在第壹文秘上搜索。

1、.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.in

2、ergicbronchodi1.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.oUSIyUscdpressureco

3、nncctorssuch1.SOHreathingindudestwoconnectorattherespiratorytbing.connectors,ISO17256,dnvenmandatedusi11conerespiratoryA.13Rationa1.eformaximumtemperatureofthe1.iquidcontainer9.3.1b)ingredients,suchnebu1.izedproteinsorDNAcomponents,canbesensitivetotemperatureandA.14Rationa1.efora1.ternativetestmetho

4、ds9.3.2k)assessment,chTomatographymethodshavespectrophotometr),againstcanBecascadeimpactionrepeatedperformance.15Rationa1.eforsoundpressure1.eve1.s9.3.2m)A.16Rationa1.efortestprincip1.eC.1.(MnRtt.i1.Disrta辆hhimCb1.sUiMrfi2venwh1.nibuqy1.ijn)t1.erhQJcQmWtejvfstHcipaticntoutif1.1.hdesnebu1.izerand1.os

5、t.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.efortestc

6、onditionsC.2Thecommitteechosetheseconditionstorepresenttheconditionsaffectingthemajorityofgenera1.tmht11ManmJP1.1.Ctfmtreyre)resenthUmKtyfonCtnebu1.izersWiH1.in1.feHiOttawce.systems,wherehigherA.18Rationa1.efortestequipcmentC3Abreathingsimu1.atorisusedwhendeterminingtheaeroso1.outputfromanebu1.izeri

7、nordertoth京刖iEUhdgirifmdatedaecoHumeegaibeIPhhm用ini而对IgFedimtrPio翻edx)Mttetwi(tefpatientpopu1.ations,Itcou1.dbeusefu1.toana1.ysemu1.tip1.ebreathingpatternsassociatedwithdifferentpatientopu1.ations(26.19Rationa1.efortestmethodC,4Measurementsofmassratherthanvo1.umea1.onecorrectforevaporative1.osses.A.

8、20Rationa1.efortestprincip1.eD,1.Acontinuoussuctionpumpisusedfornebu1.izedaeroso1.sizetestingbecauseimpactorsforperformingthesemeasurementsneedtooperateataconstantinha1.ationowratetoreasonab1.yestimateaeroso1.size.14AnnexB(informative)Diametersofrespirab1.efractionpartic1.esIngenera1.itisconsideredt

9、hataeroso1.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.G

10、SD:Thisshou1.dbeca1.cu1.atedon1.yifthepartic1.esizedistributioncurveisreasonab1.ystraightbetween10%and90%,showingthattheaeroso1.is1.og-norma1.1.ydistributed.Whereastraight1.ineisagoodfit箱d49(m船rkW1.AB白肝sifeVfbKrthU1.W由怛CroS咫岛3g8F5whichthe1.inecrossesThenrtheGSD=(XY)rca1.ibratedandoperatingat151/min

11、.3.1TestequipmentThetestequipment(seetheschematicdiagraminFigure1).1)prise:a) thenebu1.izingsystemundertest;b) acascadeimpactor:1) withat1.easteightstagestoestimatetherespirab1.efraction;2) withSufTiden1.1.oadingcapacityoneachstagetoestimatetherespirab1.efractionwithoutover1.oadinganystage；3) withno

12、measurab1.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.19ISO2023-A1.1.rightsreservedh3a31.Rft1.idiff1.nountahik)cchtscasDd1.tn