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ISO2014WRITINGANDMARKINGINSTRUMENTSSPECIFICATIONFORCAPSTOREDUCETHERISKOFASPHYXIATIONINSTRUMENTSPOURLCRITUREETLEMARQUAGESPCIFICATIONSPOURLESCAPUCHONSAFINDERDUIRELERISQUEDASPHYXIEINTERNATIONALSTANDARDISO11540SECONDEDITION20140315REFERENCENUMBERISO115402014ECOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,ISO115402014EIIISO2014ALLRIGHTSRESERVEDCOPYRIGHTPROTECTEDDOCUMENTISO2014ALLRIGHTSRESERVEDUNLESSOTHERWISESPECIFIED,NOPARTOFTHISPUBLICATIONMAYBEREPRODUCEDORUTILIZEDOTHERWISEINANYFORMORBYANYMEANS,ELECTRONICORMECHANICAL,INCLUDINGPHOTOCOPYING,ORPOSTINGONTHEINTERNETORANINTRANET,WITHOUTPRIORWRITTENPERMISSIONPERMISSIONCANBEREQUESTEDFROMEITHERISOATTHEADDRESSBELOWORISOSMEMBERBODYINTHECOUNTRYOFTHEREQUESTERISOCOPYRIGHTOFFICECASEPOSTALE56CH1211GENEVA20TEL41227490111FAX41227490947EMAILCOPYRIGHTISOORGWEBWWWISOORGPUBLISHEDINSWITZERLANDCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,ISO115402014EISO2014ALLRIGHTSRESERVEDIIICONTENTSPAGEFOREWORDIVINTRODUCTIONV1SCOPE12TERMSANDDEFINITIONS13REQUIREMENTS131GENERAL132CAPSIZE133VENTILATEDCAPSAIRFLOW234TESTREPORT24IDENTIFICATION3ANNEXANORMATIVETESTFORAIRFLOW4ANNEXBINFORMATIVEDESIGNGUIDANCEFORPENCAPSVENTAREA6BIBLIOGRAPHY7COPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,ISO115402014EFOREWORDISOTHEINTERNATIONALORGANIZATIONFORSTANDARDIZATIONISAWORLDWIDEFEDERATIONOFNATIONALSTANDARDSBODIESISOMEMBERBODIESTHEWORKOFPREPARINGINTERNATIONALSTANDARDSISNORMALLYCARRIEDOUTTHROUGHISOTECHNICALCOMMITTEESEACHMEMBERBODYINTERESTEDINASUBJECTFORWHICHATECHNICALCOMMITTEEHASBEENESTABLISHEDHASTHERIGHTTOBEREPRESENTEDONTHATCOMMITTEEINTERNATIONALORGANIZATIONS,GOVERNMENTALANDNONGOVERNMENTAL,INLIAISONWITHISO,ALSOTAKEPARTINTHEWORKISOCOLLABORATESCLOSELYWITHTHEINTERNATIONALELECTROTECHNICALCOMMISSIONIECONALLMATTERSOFELECTROTECHNICALSTANDARDIZATIONTHEPROCEDURESUSEDTODEVELOPTHISDOCUMENTANDTHOSEINTENDEDFORITSFURTHERMAINTENANCEAREDESCRIBEDINTHEISO/IECDIRECTIVES,PART1INPARTICULARTHEDIFFERENTAPPROVALCRITERIANEEDEDFORTHEDIFFERENTTYPESOFISODOCUMENTSSHOULDBENOTEDTHISDOCUMENTWASDRAFTEDINACCORDANCEWITHTHEEDITORIALRULESOFTHEISO/IECDIRECTIVES,PART2SEEWWWISOORG/DIRECTIVESATTENTIONISDRAWNTOTHEPOSSIBILITYTHATSOMEOFTHEELEMENTSOFTHISDOCUMENTMAYBETHESUBJECTOFPATENTRIGHTSISOSHALLNOTBEHELDRESPONSIBLEFORIDENTIFYINGANYORALLSUCHPATENTRIGHTSDETAILSOFANYPATENTRIGHTSIDENTIFIEDDURINGTHEDEVELOPMENTOFTHEDOCUMENTWILLBEINTHEINTRODUCTIONAND/ORONTHEISOLISTOFPATENTDECLARATIONSRECEIVEDSEEWWWISOORG/PATENTSANYTRADENAMEUSEDINTHISDOCUMENTISINFORMATIONGIVENFORTHECONVENIENCEOFUSERSANDDOESNOTCONSTITUTEANENDORSEMENTFORANEXPLANATIONONTHEMEANINGOFISOSPECIFICTERMSANDEXPRESSIONSRELATEDTOCONFORMITYASSESSMENT,ASWELLASINFORMATIONABOUTISOSADHERENCETOTHEWTOPRINCIPLESINTHETECHNICALBARRIERSTOTRADETBTSEETHEFOLLOWINGURLFOREWORDSUPPLEMENTARYINFORMATIONTHECOMMITTEERESPONSIBLEFORTHISDOCUMENTISISO/TC10,TECHNICALPRODUCTDOCUMENTATIONTHISSECONDEDITIONCANCELSANDREPLACESTHEFIRSTEDITIONISO115401993,WHICHHASBEENTECHNICALLYREVISEDIVISO2014ALLRIGHTSRESERVEDCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,ISO115402014EINTRODUCTIONIFACHILDINHALESAPENCAPITMIGHTBECOMELODGEDBELOWTHELARYNXANDBLOCKTHETRACHEATHERISKOFASPHYXIATIONCANBEREDUCEDIFTHEPENCAPISVENTILATEDORTOOLARGETOENTERTHEAIRWAYCHILDRENHAVETOBEACTIVELYDISCOURAGEDFROMSUCKING,CHEWING,ORPUTTINGPENCAPSINTHEIRMOUTHSAWAYOFAVOIDINGTHERISKOFINHALATIONOFCAPSOFWRITINGANDMARKINGINSTRUMENTSISTOMANUFACTUREPRODUCTSWITHOUTCAPSWHENEVERPOSSIBLEHOWEVER,IFCAPSAREESSENTIAL,THEPROVISIONSOFISO11540MINIMIZERISKBYSPECIFYINGTHEDESIGNANDPERFORMANCEOFVENTILATEDCAPSWHICHREDUCETHELIKELIHOODOFINHALATIONANDDELAYSASPHYXIATIONPENDINGMEDICALINTERVENTIONISO/TC10RECOGNIZESTHATWHILEITISPOSSIBLETOIDENTIFYTHEAGERANGEOFTHECHILDRENWHOAREMOSTATRISK,ITISNOTPOSSIBLETOIDENTIFYWITHCERTAINTYANYWRITINGINSTRUMENTSWITHDETACHABLECAPSTHATWOULDNEVERBEACCESSIBLETOCHILDRENANDHENCENEVERPOSEARISKITIS,HOWEVER,ACKNOWLEDGEDTHATCERTAINPRODUCTSIEWRITINGANDMARKINGINSTRUMENTSWHICHAREDESIGNEDORONLYINTENDEDFORUSEBYADULTS,EGJEWELLERYPENS,EXPENSIVEFOUNTAINPENS,PROFESSIONALTECHNICALPENSARENOTINTENDEDFORUSEBYCHILDRENANDSUCHITEMSHAVETOBECLEARLYLABELLEDTOTHATEFFECTISO2014ALLRIGHTSRESERVEDVCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,COPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,WRITINGANDMARKINGINSTRUMENTSSPECIFICATIONFORCAPSTOREDUCETHERISKOFASPHYXIATION1SCOPETHISINTERNATIONALSTANDARDSPECIFIESREQUIREMENTSTOREDUCETHERISKOFASPHYXIATIONFROMCAPSFORWRITINGANDMARKINGINSTRUMENTSITRELATESTOSUCHINSTRUMENTSWHICHINNORMALORFORESEEABLECIRCUMSTANCESARELIKELYTOBEUSEDBYCHILDRENUPTOTHEAGEOF14YEARSTHISINTERNATIONALSTANDARDISNOTAPPLICABLETOTHEFOLLOWINGWRITINGANDMARKINGINSTRUMENTSWHICHAREDESIGNEDORONLYINTENDEDFORUSEBYADULTS,EGJEWELLERYPENS,EXPENSIVEFOUNTAINPENS,PROFESSIONALTECHNICALPENSTRANSITCAPSFORREFILLS2TERMSANDDEFINITIONSFORTHEPURPOSESOFTHISDOCUMENT,THEFOLLOWINGTERMSANDDEFINITIONSAPPLY21WRITINGANDMARKINGINSTRUMENTSINSTRUMENTSFORWRITINGORMARKINGWITHADETACHABLECAP,INCLUDINGPENSWITHASELFCONTAINEDRESERVOIROFINKOROTHERMARKINGFLUID22CAPDETACHABLECLOSUREDESIGNEDTOCOVERTHEWRITINGORMARKINGTIPWHENNOTINUSE3REQUIREMENTS31GENERALCAPSSHALLCONFORMTOATLEASTONEOFTHEFOLLOWING32OR3332CAPSIZEWHENACAPISINTRODUCEDWITHITSMAINAXISPERPENDICULARTOA16000005,MMDIAMETERRINGGAUGEOFATLEAST19MMTHICKNESS,ANDPARTOFTHECAPENTERSTHEGAUGE,ATLEAST5MMOFTHELENGTHSHALLNOTENTERUNDERITSOWNWEIGHT,SEEFIGURE1NOTECAPSWHICHCONFORMTOTHISSUBCLAUSEAREDEEMEDTOBETOOLARGETOPRESENTANINHALATIONHAZARDINTERNATIONALSTANDARDISO115402014EISO2014ALLRIGHTSRESERVED1COPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,ISO115402014E123165MM00500019MMMMKEY1DIRECTIONOFFALL2RINGGAUGE3CAPFIGURE1SCHEMATICDIAGRAMOFGAUGE33VENTILATEDCAPSAIRFLOWWHENTESTEDINACCORDANCEWITHANNEXA,CAPSSHALLPERMITAMINIMUMAIRFLOWOF8L/MIN,MEASUREDATROOMTEMPERATURE,WITHAMAXIMUMPRESSUREDROPOF1,33KPANOTE1FORCAPSRELYINGONINTERNALVENTILATION,ASINGULARCIRCULARORIFICEWITHACROSSSECTIONALAREAOFAPPROXIMATELY3,4MM2CANBEEXPECTEDTOSATISFYTHISCRITERION,BUTMULTIPLESMALLORIFICESMIGHTREQUIREALARGERTOTALCROSSSECTIONALAREANOTE2GUIDANCEISGIVENINANNEXBFORCAPSTHATRELYONEXTERNALVENTILATIONNOTE3CAPSCONFORMINGTOTHISSUBCLAUSEAREDEEMEDTONOTPRESENTANASPHYXIATIONHAZARD34TESTREPORTTHEREPORTSHALLINDICATEWHETHERTHECAPCONFORMSTO32OR33THETESTREPORTSHOULDINDICATEATLEASTTHEFOLLOWINGINFORMATIONATHESIZEOFTHETUBINGUSEDSEEA26ANDITSRELATIONSHIPTOTHECIRCUMSCRIBINGCIRCLEOFTHECAPSTESTED2ISO2014ALLRIGHTSRESERVEDCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,ISO115402014EBTHENUMBEROFCAPSTESTED,THEAIRFLOWOFEACHCAPINBOTHDIRECTIONS,ANDTHEMINIMUMAIRFLOWRECORDED4IDENTIFICATIONWRITINGORMARKINGINSTRUMENTS,ORTHEIRPACKAGINGORACCOMPANYINGDOCUMENTATION,SHALLBELEGIBLYANDINDELIBLYIDENTIFIEDWITHTHENAME,TRADEMARK,OROTHERMEANSOFIDENTIFYINGTHEMANUFACTURERAND/ORSUPPLIERISO2014ALLRIGHTSRESERVED3COPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,ISO115402014EANNEXANORMATIVETESTFORAIRFLOWA1PRINCIPLETHETESTCAPISFULLYINSERTEDINTOANELASTOMERICTUBEOFTHEAPPROPRIATEDIAMETERANDTHEAIRFLOWTHROUGHTHETUBEANDTHEPRESSUREDROPAREMEASUREDINBOTHDIRECTIONSA2APPARATUSA21AIRSUPPLY,PULSEFREEANDWITHAFLOWRATEOFATLEAST25L/MINWITHINTHEPRESSURERANGEOF4KPATO50KPAA22FLOWREGULATOR,CAPABLEOFCONTROLLINGTHEAIRFLOWWITHANACCURACYOF0,1L/MINA23FLOWGAUGE,CAPABLEOFMEASURINGAFLOWRATEOFBETWEEN5L/MINAND10L/MINWITHANACCURACYOF0,2L/MINA24PRESSUREGAUGE,CAPABLEOFMEASURINGAPRESSUREOFATLEAST4,00KPATOANACCURACYOF0,01KPAA25COUPLINGANDTUBING,SUITABLEFORCONNECTINGEQUIPMENTDESCRIBEDABOVEINACCORDANCEWITHFIGUREA1A26ELASTOMERICTUBING,WITHANINTERNALDIAMETEROF80TO85OFTHATOFTHECIRCUMSCRIBINGCIRCLEOFTHECAPTOBETESTED,MEASUREDATITSWIDESTPOINTWITHAWALLTHICKNESSOF0,75MM0,25MMANDSHOREAHARDNESSOF5510NOTE1THEAPPARATUSISILLUSTRATEDINFIGUREA1NOTE2TUBINGOFDIAMETERSAPPROPRIATETOTHECAPBODYMIGHTBEDIFFICULTTOOBTAINANDITMIGHTBEADVANTAGEOUSTOMANUFACTURETHETUBING,ASREQUIRED,BYADIPMOULDINGTECHNIQUEA3PROCEDUREA31CUTTHEELASTOMERICTUBINGSEEA26INTOALENGTHSUCHTHATWHENTHECAPISINSERTEDTHEREISARELAXEDDIAMETEROFTUBINGATBOTHENDSOFTHECAPWHENCONNECTEDINTHEAPPARATUSAPPLYASOAPSOLUTIONOROTHERSUITABLELOWVISCOSITYLUBRICANTTOTHEFULLINTERNALAREAOFTHETUBINGINSERTTHECAPINTOAPPROXIMATELYTHECENTREOFTHETUBELENGTHANDENSURETHAT,ASFARASPRACTICABLE,THECAPISPARALLELTOTHEMAJORAXISOFTHETUBINGA32USINGSUITABLECONNECTORSANDTUBING,CONNECTTHETUBE/CAPASSEMBLYSEEA33TOTHEAPPARATUS,INACCORDANCEWITHFIGUREA1TURNONTHEAIRSUPPLYANDADJUSTTHEFLOWUNTILTHEPRESSUREGAUGEINDICATESAPRESSUREDIFFERENCEOF1,33KPARECORDTHEFLOWRATEINDICATEDONTHEFLOWGAUGEATTHISPRESSUREA33TURNOFFTHEAIRSUPPLY,REMOVEANDREVERSETHETUBE/CAPASSEMBLYANDREPEATA32TESTTHECAP,GIVINGTHEAIRFLOWRESULTSFOUNDINEACHDIRECTIONA34COMPLETETHETESTREPORTSEE344ISO2014ALLRIGHTSRESERVEDCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,ISO115402014E2345671KEY1AIRSUPPLY2FLOWCONTROLVALVE3FLOWMETER4PRESSUREGAUGE5ELASTOMERICTUBING6CAP7AIREXHAUSTFIGUREA1SCHEMATICDIAGRAMOFTESTRIGISO2014ALLRIGHTSRESERVED5COPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATION,ISO115402014EANNEXBINFORMATIVEDESIGNGUIDANCEFORPENCAPSVENTAREAACONTINUOUSAIRPASSAGEOFALEAST6,8MM2SHOULDEXTENDFORTHELENGTHOFTHECAPBODYTOWITHIN2MMOFBOTHENDSTHECROSSSECTIONALAREAOFTHECONTINUOUSAIRPASSAGE,IFNOTENTIRELYENCLOSED,SHOULDBETHATAREATHATWOULDBEENCLOSEDBYATHINPIECEOFCOTTONTHREADWRAPPEDTAUTLYAROUNDANYSECTIONPERPENDICULARTOTHEMAINAXISORTHELARGESTDIMENSIONSEEFIGUREB1ALTERNATIVELY,THISAREACANBECALCULATEDUSINGACADSYSTEMWHEREACLIPOROTHERPROTRUSIONISTHEMEANSOFPROVIDINGTHEAIRPASSAGEITSHOULDBESECURELYFIXEDANDITSHOULDEXTENDTOWITHINATLEAST2MMOFEACHENDOFTHECAPBODYNOTE1THECLIPCANEXTENDANYDISTANCEBEYONDTHEENDOFTHECAPBODYNOTE
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