ISO 27427-2023.docx

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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

13、-A1.1.rightsreservedh3a31.Rft1.idiff1.nountahik)cchtscasDd1.tnc(br.bc1.wecnthenebu1.izeraeroso1.out1.etportand油嬲限盅濯胪谭骋四混献麋号蹄翱硒4thD.3.2.5Theowofthesamp1.ingpumpissetto(155%)1.min.NOTE1.manutacturer.Duringtestingthenebu1.izerandthecascadeimpactoraresecuredinthepositionspecifiedbytheNOTE2Careshou1.dbet

14、akentopreventvibrationoftheimpactorandtominimizeperturbationoff1.owthroughthetestapparatus.D.3.2.6Thesamp1.ingpumpisturnedonanda1.1.owedtostabi1.izeattherequiredf1.ow.D.3.2.7Thenebu1.izerisstarted.D.3.2.8Samp1.ingtimescanbevariedfordifferentnebu1.izerstoa1.1.owformaximumdepositiononeachstagewithouto

15、ver1.oadingthestages.NwghitionS由叩匕SiibyUettcJoestab1.ishtheoptimumperiodoftest,aidedbyvisua1.thenebu1.izerisswitchedoff,andthenafewseconds.1sarnpfingsaRp1.1.Rorswi1.chcdrenredtime.D.3.2.10Thecascadeimpactorisdismountedfromtheremainderoftheapparatus.D.3.2.11Theimpactorisdismant1.edaccordingtothemanuf

16、acturersinstructionsandthemassoftest峪帮P?殳.骅individua1.stagesoftheimpactor,theinputconnection,andtheout1.etfi1.terisdetenninedP羽12A1.1.type-testmethodssha1.1.beperformedonat1.eastthreerepresentativetestdevices.SeeD.4Testusingacascadeimpactorca1.ibratedandoperatingat1.essthan151./minD.4.1Testequipment

17、Thetestequipment(seetheschematicdiagraminFigureD.2)prise：a) CbmiMi和也物朋处助Ikm憎。线地耳巾/匕小钠拈跟班刚他加反卜计咏加伸中喇泗网b) acascadeimpactor:1) withat1.easteightstagestoestimatetherespirab1.efraction；2) withsufficient1.oadingcapacityoneachstagetoestimatetherespirab1.efractionwithoutover1.oadingstages;3) withnomeasurab1

18、.eheattransfer-re1.ateddrop1.etevaporation;NOTE1Theimpactorcanhechi1.1.edtoavoidthiscauseOfinaccuracy.潴机/蜘ngouHe物疑emfi1.1.edwithtestso1.utionwithanentrainedambientairin1.et(i.e.T-piece),ifrequireddsmounub1.econnectors4 co1.1.ectionfi1.terforexcessaeroso1.5 suctionpump6 Tpiccc7 cascadeimpactor8 conne

19、ctortosamp1.ingpump9 samp1.ingpumphb，曲蜀食一Schematicdiagramshowingtheequipmentfortestingthepartic1.esizesD.4.2TestmethodD.4.2.1Thenebu1.izerisfi1.1.edwiththetestso1.utiontothefi1.1.vo1.umerecommendedbythempifainureraccordj)11niifithndUvdmri1.urermWWtxneodcdandconnectedtothetestcompressororairD.4.2.2AT

20、-pieceisattachedtotheaeroso1.oudetport.D.4.2.3Thecascadeimpactorisdismant1.ed,c1.eaned(e.g.withdisti1.1.edwater,wipedanda1.1.owedto两5fX1.cftrsJ龈出用IR8;incorporatinga1.1.thestagesOfimpactionsurfacesinaccordancewiththeD.4.2.4tthcascadei11mactprandfrom.madethistheT-piecctofc4.1.1.ofthe,.,whichisaftacnee

21、ad11yasmountaDeConnectionstheareoutieto11romconectortothetheco1.1.ecuon111.ter,connectorconnectedtoasuctionpump.Tab1.eD.1.Typica1.setsofresu1.tsfromrepeatmeasurementofacascadeimpactorStageno.Effectivecut-of1.diameterCumu1.ativepartic1.emassofa1.butero1.undersize%214,894,193,094,192/97.121,396,295,49

22、6,095,6处,7KeyIY1.probabi1.ity(zva1.ues)Y2cumu1.ativepercentMMAD(3,9m)MMDD(-1)三GSDorD(I)/MMAD=GSD(2.06)cumu1.ative%1.essthan5m(60%)&8件(inthisP僧HIeteIsaffe蚯rffc改匕X?加阴甲6像田都mthearrow)andpercentaeroso1.so1.utemassbe1.owFigureD.3Examp1.ep1.otofcumu1.ativesizedistributionfromresu1.tsinTb1.c.D.1.4) highoxyg

23、enconcentration;5) airwayobstruction;6) inadequatespontaneousventi1.ation;7) reactiveairwaysdisease;8) bronchospasm,Iaryngospasm,stridorrhiccup,coughing,breathho1.ding;9) negativepressurepu1.monaryoedema;10) rebreathing;11) increasedintrathoracicpressure;12) thickenedsecretions,mucusp1.ugs.c)/Xspira

24、tionorregurgitationdueto:1) aspirationofbu1.knebu1.izerso1.utions,water,orsa1.ine；2) inadequateattachmenttoor1.ockingofthetrachea1.tubeorotherairwaydevice;3) gastricinsu1.ations;4) inabi1.itytoevacuategastriccontents;5) airwayobstruction(kinkingornarrowing)withspontaneousbreathing,d)Toxicity:1) a1.1

25、.ergy,inc1.uding1.atex;2) smokeinha1.ationinjury;3) oxygentoxicity;4) inha1.ationofc1.eaningand/ordisinfectionso1.utions;5)疝阂ion(99的标fi11曲卜柳8砧咫洲而阕BHN用加dftWrf.diethy1.enetriaminepenta-acetice)Pharmaco1.ogicinjuryduetoexcessive/inadequateaeroso1.de!ivey:1) tachycardia;2) bradycardia;3) cardiopu1.monar

26、yfai1.ure；4) hypertension/hypotension;5) hypervo1.emia;6) unconsciousness；7) death.28E.2Potentia1.nebu1.ixerdevicehazardsPotentia1.hazardsareasfo1.1.ows:a) Fire:1) overheating;2) e1.ectrica1.ma1.function,shortcircuits,sparks.b) Fragmentation:1) brokencomponents;2) detachedcomponents.c) Inadequateoxy

27、gen:1) damagedairentrainmentdia1.;2) damagedoxygenconnector.d) Misconnection:1) nebu1.izerconnecteddirect1.ytoatrachea1.tube;2) nebu1.izerconnectedtothewrongportofaventi1.ator.e) 1.owaeroso1.output1) missingcomponents;2) damagedcomponents;3) e1.ectrica1.fai1.ure.E.3Potentia1.riskcontro1.sPotentia1.r

28、iskcontro1.sareasfo1.1.ows:a) designb) instructionsforuseC)1.abe1.1.ingd) pre-usecheckse) CdUCatkm/trainingf) compatibi1.itytestingg) disc1.osureh) riskassessmentAnnexF(informative)C1.assificationofgenera1.-purposenebu1.izersF.1.C1.assificationbyaeroso1.matterphaseorstatedrypowderaeroso1.s(exc1.uded

29、fromthisdocument)1.iquidaeroso1.sF.2C1.assificationbydurationF.2.1Continuousnebu1.izersaeroso1.producedcontinuous1.yovermu1.tip1.einha1.ations/exha1.ationsF.2.2Breath-actuatednebu1.izers triggeredmechanica1.1.y(bythepatientoninha1.ation) triggeredbynegative/positiveinha1.ation/exha1.ationpressure tr

30、iggeredbyf1.ow triggeredbyvo1.ume triggeredbyinha1.ation/exha1.ationgastemperaturechange triggeredthroughoutinha1.ation triggeredduringthefirstfractionofinha1.edtida1.vo1.umetriggeredtheendexha1.ationF.23C1.assificationbyprope1.1.antF.2.4Gas-powerednebu1.izersatomizers,1.iquidandgasforcedthroughtheo

31、rificeunderhighpressure-Babingtonsty1.e(waterf1.owingoveraspherewithagasjet,withorwithoutimpactor)Venturisty1.e(aspiratingorifices) perpendicu1.arorifices,oneforgas,onefordrugs concentricorificeswithconcentriccy1.inders withorwithoutimpactor Withorwithoutoxygendi1.utionbyairentrainment withorwithout

32、condensingdevicestocontro1.outputandpartic1.esizeF.2.5Spinningdiscnebu1.izersspinningdisc(orp1.ate)prope1.spumpedi11g1.iquidintoimpactorcombsF.2.6U1.trasonicnebu1.izers-piezoe1.ectrictransducersinacoup1.ant1.iquidP-2.7piWettnigWburersactingdirect1.yonthedrugvibratingactivemeshvibratingpassivemeshvib

33、ratingcapi1.1.ary1I2H1.5678i1.(11112(1314(151617IB1912O(21221(2332Bib1.iography性照刚Q幽r-W网评娜娜钺畿磁粉的叱哂晒/如嬲翻叱3ISO5361,4neste11candrespiratoryequipmentTrachca1.tubesandconnectorsISO5367,/InaesfhetfcandrespiratoryequipmentBreathingsetsandconnectorsRWWTOeN厢NdZqiWtgMvf1.gHttf1.Wgaspipe1.inesystemsPart1:Termi

34、na1.unitsforusewithISO9276-1,Representationofresu1.tsofpartic1.esizeana1.ysis-Part1:Graphica1.representationfimud吟2762ft*p径&wNAtan；呻泣制ItinentSfrompartic1.eSiZe(IhIfi1.M)nsPart2:Ca1.cu1.ationofaverage也钟姗j印,殆腕解豳阁而他厅用砒映区施超6留物感施联占附b例解谕厕免PmfS6粗过魔剜喉GWd同舱Mf幽宽加由*CdjCHgaSeS-Part1:Pressureregu1.atorsandISO150

35、02,F1.ow-meteringdevicesforconnectiontotermina1.unitsofmedica1.gaspipe1.inesystemsISO17256,AnaestheticandrespiratoryequipmentRespiratorytherapytubingandconnectors的OIg出4中浦银姗弁#酬鞘阍阳&i即随回曲皿q*)forma1.iontobeprovidedbythemedica1.deviceISO20072:2009.Aeroso1.drugde1.iverydevicedesignverificationRequirements

36、andrestmethodsISO20789:2017MnaeSr加ticandrespiratoryequipmentPassivehumidifiersISO80369,Sma1.1.-boreconnectorsfor1.iquidsandgasesinhea1.thcareapp1.ications第托晌屯74成的“痛防Ctr1筛Ut阳H&nii瞅附碗洲画图曲requirementsforbasicsafety注树跟脚t部麻丽佛热的t懒杷触网雕出ectricHequipment-Part1:Genera1.IEC61672-1,E1.ectroacousticsSound1.eve1.

37、metersPart1：Specifications电由caN板005粒明MOnSindexsafetysystemNonmterchangeab1.e1.owpressureconnectionsforNFPA53MManua1.onfirehazardsinoxygenenrichedatmosphere,Nationa1.FireProtectionAssociation,1BatterymarchPark,P.O.Box9101,Quincy,M02269-9101.USDennis.H.PieronCA.,Page1.s.SmurthwaiteM.rNcrbrink0.,Deve1.

38、opmentandapp1.icationofa1.owf1.owcascadeimpactortosizenebu1.izedaeroso1.s.J.Aeroso1.Med.1999,12p.134EuropeanPharmacopoeia,Inha1.anda(Sthedition)2005c99dndActft8srAdf1.ttRft1.0n,1993RcviewcrGuidanceforNebu1.izers,MctcredDoseInha1.ers,NivenRV.eta1.Somefactorsassociatedwiththeu1.trasonicnebu1.izationof

39、proteins.Pharm.Res.1995Jan.12pp.53-59ISO2023-A1.1.rightsreserved2425iknrjti8buitxurSitiQuricB6aR.Axwi!ethfuiAiHM1.1.ersrBdisurementtfendrjtkjpJtt1.sMddutput.Thorax.1990Oct.45pp.728-732Mfi，加ed1.itrepod!We洛任Pa口由?桶彳鼠备恃|?台28*4端常业7designs:constant-output.26Do1.ovichM.,Mitche1.1.J.,CanadianStandardsAssoci

40、ationStandardCANCSAZ264.1-ftQg在禽ygw“帕IfGa仔St辟加雨1%04,SpX用and融删科6ChambersUsedwithPressurized27 HeyderJ.,GebhartJ,Rodu1.fT.G.,Schi1.1.erCE,Stah1.hofenW.,Depositionofpartic1.esinthehumanrespiratorytractinthesizerange0,005-15m.J.eso1.Sci.1986,17pp.811-8252928 Stah1.hofenW.,Rudo1.phG.,JamesA.C.,Intercomparisonofexperimenta1.regiona1.depositiondata.J.Aeroso1.Med.1989,2pp.285-308HXMifeV,Eur.(!tMxghd9的MAyiT1.BPitH)hniy69oftheoutputOfsa1.butamo1.fromdifferent