1、EuropeanstandardNormeeuropeenneEuropaischenormICS11.040.10ENISO7376:2020AlJune2025EnglishVersionAnaestheticandrespiratoryequipment-Laryngoscopesfortrachealintubation-Amendment1:Clarificationofopticaloutputandilluminationrequirements(ISO7376:2020/Amd1:2025)Materieldanesthesieetdereanimationrespiratoi
2、re-Laryngoscopespourintubationtracheale-Amendement1:ClarificationconcernantlapuissanceoptiqueetlesexigencesrelativesaVeclairage(ISO7376:2020/Amd1:2025)Anasthesie-undBeatmungsgerate-LaryngoskopefiirTFachealintubation-Anderung1(ISO7376:2020/Amd1:2025)ThisamendmentAlmodifiestheEuropeanStandardENISO7376
3、2020;itwasapprovedbyCENon15December2024.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforinclusionofthisamendmentintotherelevantnationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedona
4、pplicationtotheCEN-CENELECManagementCentreortoanyCENmember.Thisamendmentexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions
5、CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,S
6、pain,Sweden,Switzerland,TiirkiyeandUnitedKingdom.富EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITEEUROPEENDENORMALISATIONEuropaischeskomiteefurnormungCEN-CENELECManagementCentre:RuedelaScience23,B-1040BrusselsRef.No.ENISO7376:2020/Al:2025E2025CENAHrightsofexploitationinanyformandbyanymeansreservedworldwide
7、forCENnationalMembers.ContentsPageEuropeanforeword3EuropeanforewordThisdocument(ENISO7376:2020/Al:2025)hasbeenpreparedbyTechnicalCommitteeISO/TC121AnaestheticandrespiratoryequipmentincollaborationwithTechnicalCommitteeCEN/TC215,Respiratoryandanaestheticequipment11thesecretariatofwhichisheldbyBSLThis
8、AmendmenttotheEuropeanStandardENISO7376:2020shallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyDecember2025,andconflictingnationalstandardsshallbewithdrawnatthelatestbyDecember2025.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocum
9、entmaybethesubjectofpatentrights.CENshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.Anyfeedbackandquestionsonthisdocumentshouldbedirectedtotheusersnationalstandardsbody/nationalcommittee.AcompletelistingofthesebodiescanbefoundontheCENwebsite.AccordingtotheCEN-CENELECInternalRegulatio
10、ns,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Re
11、publicofNorthMacedonia,Romania,Serbia,Slovakia,SlovenialSpain,Sweden,Switzerland,TiirkiyeandtheUnitedKingdom.EndorsementnoticeThetextofISO7376:2020/Amd1:2025hasbeenapprovedbyCENasENISO7376:2020/Al:2025withoutanymodification.ISOInternationalStandardISO7376Thirdedition2020-08AMENDMENT12025-06ISO2025An
12、aestheticandrespiratoryequipmentLaryngoscopesfortrachealintubationAMENDMENT1:ClarificationofopticaloutputandilluminationrequirementsReferencenumberISO7376:2020/Amd.l:2025(en)COPYRIGHTPROTECTEDDOCUMENTISO2025Allrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofitsimplementation,nopartof
13、thispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO,smemberbodyinthecountryoftherequester.ISOcopyrightofficeCP4
14、01Ch.deBlandonnet8CH-1214Vernier,GenevaPhone:+41227490111Email:copyrightiso.orgWebsite:www.iso.orgPublishedinSwitzerlandForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarrie
15、doutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElect
16、rotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.Thisdocumentwa
17、sdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(seeWWW.iso.org/directives).ISOdrawsattentiontothepossibilitythattheimplementationofthisdocumentmayinvolvetheuseof（八）patent(三).ISOtakesnopositionconcerningtheevidence,validityorapplicabilityofanyclaimedpatentrightsinrespectthereof.
18、Asofthedateofpublicationofthisdocument,ISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimplementthisdocument.HoweverlImplementersarecautionedthatthismaynotrepresentthelatestinformation,whichmaybeobtainedfromthepatentdatabaseavailableatWWW.iso.org/patents.ISOshallnotbeheldresponsibleforident
19、ifyinganyorallsuchpatentrights.Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO,sadherencetothe
20、WorldTradeOrganiZationWTO)principlesintheTechnicalBaierstoTradeOBT,seewww.iso.org/iso/foreword.htmLThisdocumentwaspreparedbyTechnicalCommitteeISO/TC121,Anaestheticandrespiratoryequipment,SubcommitteeSC2,Airwaydevicesandrelatedequipment,incollaborationwiththeEuropeanCommitteeforStandardization(CEN)Te
21、chnicalCommitteeCEN/TC215,Respiratoryandanaestheticequipment,inaccordancewiththeAgreementontechnicalcooperationbetweenISOandCEN(ViennaAgreement).AlistofallpartsintheISO7376seriescanbefoundontheISOwebsite.Anyfeedbackorquestionsonthisdocumentshouldbedirectedtotheusersnationalstandardsbody.Acompletelis
22、tingofthesebodiescanbefoundatwww.iso.orH/members.htmLAnaestheticandrespiratoryequipmentLaryngoscopesfortrachealintubationAMENDMENT1:Clarificationofopticaloutputandilluminationrequirements7.1.4Replacethetextwiththefollowing:Theopticaloutputofhandlesdesignedforusewithhook-onfitting,light-guideillumina
23、tedlaryngoscopebladesshallbe3lumen.Ifamanufacturersuppliesacompletelaryngoscopesystem(handleandlight-guideilluminatedlaryngoscopebladetheilluminationrequirementsin7.2,4(500lux)supersedethisrequirement.CheckconformancebythetestmethodgiveninAnnexB.NOTETheopticaloutputrequirementisforthehandleonlyandis
24、intendedformanufacturesofhandleswhichareintendedtobeinterchangedwithmultiplelight-guideilluminatedlaryngoscopebladesfromthesameordifferentmanufacturers.7.2.4, a)tod)Replacethetextwiththefollowing:a) widestdilatationbetweenleftandrightilluminationedgesshallbegreaterthan50mmandlessthan100mm;b) widestd
25、ilatationbetweenupperandlowerilluminationedgesshallbegreaterthan30mmandlessthan80mm;c) tipOflaryngoscopebladetolowerilluminationedgeshallbelessthan3mm;d) illuminancegreaterthan500luxforaperiodoftimegreaterthan10min.SeeFigureB.l.AnnexA,SubcIause7.1,4Replacethetextwiththefollowing:Ahandlelightoutputof
26、3lumenprovidesaminimumoutputrequirementfromthehandle.Thisisspecifiedtoprovideguidancetomanufacturersfortheminimumoutputrequiredsothatwhenassembledtoabladethesystem(handleandlight-guideilluminatedlaryngoscopeblade)willachievetheilluminationrequirementsspecifiedin7.2.4.Itisacknowledgedthatthelossesthr
27、oughthebladecanvarydependingondesignandthatevenwithanoutputof3lumenanilluminationof500luxcannotbeguaranteedforallhandledevicecombinations.Thestandarddoesnotspecifytheminimumtransmissionefficiencyoftheblade.FigureB.l,keytableAddthefollowingheadertothethirdcolumnofthetable:“Requirement”B.3ff)Replace5lumenwith3lumen.ISOICS11.040.10Pricebasedon2pagesISO2025Allrightsreservediso.org
