ISO／DIS 16628：2020.docx

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1、DRAFTINTERNATIONA1STANDARDISO/DIS16628ISOTC121SC2Votingbeginson:2023-03-10Secretariat:ANSIVotingterminateson:2023-06-02Anaestheticandrespiratoryequipment-Tracheobronchia1tubesSondestracheobronchiquesDimensionnementetmarquageICS:11.040.10THISDOCUMENTISADRAFTCIRCU1ATEDFORCOMMENTANDAPPROVA1.ITISTHEREFO

2、RESUBJECTTOCHANGEANDMAYNOTBEREFERREDTOSANINTERNATIONA1STANDARDUNTI1PUB1ISHEDASSUCH.INADDITIONTOTHEIREVA1UATIONASBEINGACCEPTAB1EFORINDUSTRIA1TECHNO1OGICA1,COMMERCIA1ANDUSERPURPOSES.DRAFTINTERNATIONA1STANDARDSMAYONOCCASIONHAVETOBECONSIDEREDINTHE1IGHTOFTHEIRPOTENTIA1TOBECOMESTANDARDSTOWHICHREFERENCEMAY

3、BEMADEINNATIONA1REGU1ATIONS.RECIPIENTSOFTHISDRAFTAREINVITEDTOSUBMIT.WITHTHEIRCOMMENTS.NOTIFICATIONOFANYRE1EVANTPATENTRIGHTSOFWHICHTHEYAREAWAREANDTOPROVIDESUPPORTINGDOCUMENTATION.Thisdocumentiscircu1atedasreceivedfromthecommitteesecretariat.ISO/CENPARA11E1PROCESSINGReferencenumberISO/DIS16628:2023(E)

4、COPYRIGHTPROTECTEDDOCUMENTISO2023A11rightsreserved.Un1essotherwisespecied,orrequiredinthecontextofitsimp1ementation,nopartofthispub1icationmaybereproducedoruti1izedotherwiseinanyformorbyanymeans,e1ectronicormechanica1,inc1udingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermis

5、sion.PermissioncanberequestedfromeitherISOattheaddressbe1owor!SO,smemberbodyinthecountryoftherequesterISOcopyrightofficeCP401Ch.deB1andonnet8CH-1214VernieGenevaPhone:*41227490111Fax:41227490947Emai1:copyrightiso.orgWebsite:www.iso.orgPub1ishedinSwitzer1and12345101112ISO2017,Pub1ishedinSwitzer1andA11

6、rightsreserved.Un1essotherwisespecied,nopartofthispub1icationmaybereproducedoruti1izedotherwiseinanyformorbyanymeans,e1ectronicormechanica1,inc1udingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1oworISO,smemberbodyin

7、thecountryoftherequester.ISOcopyrightofficeCh.deB1andonnet8CP401CH-1214Vernier,Geneva,Switzer1andTe1.41227490111Fax+41227490947copyrightiso.orgwww.iso.org13 Contents14 Foreword315 Introduction416 1SCoPe517 2Normativereferences518 3Termsanddefinitions19 4Genera1requirements620 4.1Genera1621 4.2Safety

8、622 5Materia1s.623 5.1Genera1624 5.24BioIogica1safetytesting625 6Design26 6.1Genera1627 6.2Connectors.628 6.3Cuffs729 6.4Cfinf1ationsystem730 7Requirementsfortracheobronchia1tubessupp1iedsteri1e.831 8Packaging932 9Informationsupp1iedbythemanufacturer.933 9.1Ge1Iera1.“934 9.2Marking935 9.3Co1ourcodin

9、g1036 9.4Markingonthepackagingorinsert1037 AnnexA(informative)Rationa1e.1238 AnnexB(normative)Testmethodtodeterminethedesignatedsizeofthetracheobronchia139 tubeandtheoutsidediameterofthebronchia1segment.1340 AnnexC(normative)Testmethodtodeterminetheeffectiveinside由QrneterS_“1541 Bib1iography17424344

10、4546474849505152535455565758596061626364656667686970717273747576777879808182ForewordISO(theInternationa1OrganizationforStandardization)isawor1dwidefederationofnationa1standardsbodies(ISOmemberbodies).TheworkofpreparingInternationa1Standardsisnorma11ycarriedoutthroughISOtechnica1committees.Eachmember

11、bodyinterestedinasubjectforwhichatechnica1committeehasbeenestab1ishedhastherighttoberepresentedonthatcommittee.Internationa1organizations,governmenta1andnon-governmenta1,in1iaisonwithISO,a1sotakepartinthework.ISOco11aboratesc1ose1ywiththeInternationa1E1ectrotechnica1Commission(IEC)ona11mattersofe1ec

12、trotechnica1standardization.Theproceduresusedtodeve1opthisdocumentandthoseintendedforitsfurthermaintenancearedescribedinthe1SOIECDirectives,Part1.Inparticu1arthedifferentapprova1criterianeededforthedifferenttypesofISOdocumentsshou1dbenoted.Thisdocumentwasdraftedinaccordancewiththeeditoria1ru1esofthe

13、ISO/IECDirectives,Part2(seeWWW.iso.org/directives).Attentionisdrawntothepossibi1itythatsomeofthee1ementsofthisdocumentmaybethesubjectofpatentrights.ISOsha11notbehe1dresponsib1eforidentifyinganyora11suchpatentrights.Detai1sofanypatentrightsidentiedduringthedeve1opmentofthedocumentwi11beintheIntroductionand/orontheISO1istofpatentdec1arationsreceived