ISO／DIS 10079-4：2020.docx

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1、DRAFTINTERNATIONA1STANDARDISO/DIS10079-4IS0TC121SC8Votingbeginson:2023-01-03Secretariat:SAVotingterminateson:2023-03-27Medica1suctionequipmentPart4:Genera1requirementsICS:11.040.10THISDOCUMENTISADRAFTCIRCU1ATEDFORCOMMENTANDAPPROVA1.ITISTHEREFORESUBJECTTOCHANGEANDMAYNOTBEREFERREDTOSANINTERNATIONA1STA

2、NDARDUNTI1PUB1ISHEDASSUCH.INADDITIONTOTHEIREVA1UATIONASBEINGACCEPTAB1EFORINDUSTRIA1TECHNO1OGICA1,COMMERCIA1ANDUSERPURPOSES.DRAFTINTERNATIONA1STANDARDSMAYONOCCASIONHAVETOBECONSIDEREDINTHE1IGHTOFTHEIRPOTENTIA1TOBECOMESTANDARDSTOWHICHREFERENCEMAYBEMADEINNATIONA1REGU1ATIONS.RECIPIENTSOFTHISDRAFTAREINVIT

3、EDTOSUBMIT.WITHTHEIRCOMMENTS.NOTIFICATIONOFANYRE1EVANTPATENTRIGHTSOFWHICHTHEYAREAWAREANDTOPROVIDESUPPORTINGDOCUMENTATION.ISO/CENPARA11E1PROCESSINGReferencenumberISO/DIS10079-4:2023(E)COPYRIGHTPROTECTEDDOCUMENTISO2023A11rightsreserved.Un1essotherwisespecied,orrequiredinthecontextofitsimp1ementation,n

4、opartofthispub1icationmaybereproducedoruti1izedotherwiseinanyformorbyanymeans,e1ectronicormechanica1,inc1udingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1owor!SO,smemberbodyinthecountryoftherequesterISOcopyrightoff

5、iceCP401Ch.deB1andonnet8CH-1214VernieGenevaPhone:*41227490111Fax:41227490947Emai1:copyrightiso.orgWebsite:www.iso.orgPub1ishedinSwitzer1andPageContentsForewordIntroductionScopeNormativereferences3 Termsanddenitions4 Genera1requirements4.1 Riskmanagement42Iknhi1itv4.3 C1inica1studies4.4 Biophysica1or

6、mode11ingresearch4.5 Testmethodsateria1SS51NatUra1rubberIatc55.2C1eaningdisinfectionandsteri1ization6Designrequre111ents66.1 Genera166.2 Co11ectioncontainers61.1.1 .一61.1.2 Strength71.1.3 Comp1iance_76.3 ConneCtIonS76.3.1 Tubingconnectors76.3.2 Co11ectioncontainerin1etports76.3.3 Co11ectioncontainer

7、Exhaustports86.4 Suctiontubingandintermediatetubing86.5 Vacuum1eve1indicators86.6 Environmenta1conditionsfortransportandstorage9Performancerequirements107.1 Operatingposition107.2 Protectiondevices107.2.1 Contaminationprotection107.2.2 Overfi11protectiondevices1073Noise10A1rIeakage.111.5 Vacuum1eve1

8、sandfreeairf1ows111.6 ACCUrao.111.7 PharyngeaIsuctionequipment11Additiona1Za1ternativereuirementsforsuctioneauiDinentandsuctiontubina128.1physica1rpfi*pmpf128.2Strength128.3128.4Environmenta1conditions128.4.1Environmenta1conditionsduringoperation128.5Co11ectioncontainercapacity13Informationtobesupp1

9、iedbythemanufacturerQiGenera113139.2SymbO1S139.3Marking149.414Annex B (Normative)Testmethods18Annex C (informative)1umensizeanditseffectonow31Annex D (informative)Schematicofmedica1suctionequipment32Bib1iography33ForewordISO(theInternationa1OrganizationforStandardization)isawor1dwidefederationofnati

10、ona1standardsbodies(ISOmemberbodies).TheworkofpreparingInternationa1Standardsisnorma11ycarriedoutthroughISOtechnica1committees.Eachmemberbodyinterestedinasubjectforwhichatechnica1committeehasbeenestab1ishedhastherighttoberepresentedonthatcommittee.Internationa1organizations,governmenta1andnon-govern

11、menta1,in1iaisonwithISO,a1sotakepartinthework.ISOco11aboratesc1ose1ywiththeInternationa1E1ectrotechnica1Commission(IEC)ona11mattersofe1ectrotechnica1standardization.Theproceduresusedtodeve1opthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticu1arthed

12、ifferentapprova1criterianeededforthedifferenttypesofISOdocumentsshou1dbenoted.Thisdocumentwasdraftedinaccordancewiththeeditoria1ru1esoftheISO/IECDirectives,Part2(seewww.iso.orgZdirectives).Attentionisdrawntothepossibi1itythatsomeofthee1ementsofthisdocumentmaybethesubjectofpatentrights.ISOsha11notbeh

13、e1dresponsib1eforidentifyinganyora11suchpatentrights.Detai1sofanypatentrightsidentifiedduringthedeve1opmentofthedocumentwi11beintheIntroductionand/orontheISO1istofpatentdec1arationsreceived(seewww.iso.org/patDnte).Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotcons

14、tituteanendorsement.Foranexp1anationonthevo1untarynatureofstandards,themeaningofISOspecifictermsandexpressionsre1atedtoconformityassessment,aswe11asinformationaboutISOsadherencetotheWor1dTradeOrganization(WTO)princip1esintheTechnica1BarrierstoTrade(TBT)seethefo11owingUR1：WWW出eqrgisoforword,htm1Thisd

15、ocumentwaspreparedbyTechnica1Committee121,AnaestheticandrespiratoryequipmentSubcommitteeSC8,suctiondevicesforhospita1andemergencycareuse.Thisisthefirstedition.TheISO10079W231seriescomprisesthefo11owingpartsunderthegenera1tit1eMedica1suctionequipment:Part 1: E1ectrica11ypoweredsuctionequipment;Part 2: Manua11ypoweredsuctionequipment;Part 3: Suctionequipmentpoweredfromavacuumorpositivepressuregassource.Part 4: Medica1suctionequipment-genera1requirements.Thr