ENV 737-6-2003 en Medical gas pipeline systems - Part 6 Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum《医用气体管道系统 第6部分 压缩医用气体终端设备和真空终端.pdf

1、DRAFT FOR DEVELOPMENT DD ENV 737-6:2003 Medical gas pipeline systems Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum ICS 11.040.10; 23.040.60 DD ENV 737-6:2003 This Draft for Development was published under the authority of the Standards Policy

2、and Strategy Committee on 29 April 2003 BSI 29 April 2003 ISBN 0 580 41648 8 National foreword This Draft for Development is the English language version of ENV 737-6:2003, which is a Special Status European Prestandard. This publication is not to be regarded as a British Standard. It is being issue

3、d in the Draft for Development series of publications and is of a provisional nature because of the reasons given in the Foreword to ENV 737-6, i.e. principally to allow existing national standards for probes to continue in existence so that probes complying with the dimensions specified in those st

4、andards may continue to be used for new medical gas installations and the extension and maintenance of existing installations. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. BS 5682:1998 will remain in effect. A Specia

5、l Status European Prestandard differs from an ENV or Technical Specification by being exempt from the necessity of regular review as to suitability for its conversion into a European Standard, although such reviews can be undertaken should circumstances indicate. If such a review is undertaken in fu

6、ture, comments arising from the use of this Draft for Development will be requested so that UK experience can be reported to the European organization responsible for its proposed conversion into a European Standard. Notification of the start of any such review period will be made in an announcement

7、 in the appropriate issue of Update Standards and, according to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion of ENV 737-6 into a European Standard or to withdraw it. Comments relating to experience of the use of DD

8、ENV 737-6 should be sent in writing to the Secretary of BSI Technical Committee CH/121/6, Medical gas supply systems, at 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where appropriate, suggestions for revision of the text. A list of organizati

9、ons represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Corresponden

10、ce Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. Summary of pages This document comprises a front cover, an inside front cover, the ENV title page, pages 2 to 14, an inside back cover and a back cover. The BSI copyright date displayed in th

11、is document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANPRESTANDARD PRNORMEEUROPENNE EUROPISCHEVORNORM ENV7376 March2003 ICS11.040.10;23.040.60 Englishversion MedicalgaspipelinesystemsPart6:Dimensionsand allocationofprobesforterminal

12、unitsforcompressedmedical gasesandvacuum SystmededistributiondegazmdicauxPartie6: Dimensionsetattributiondesemboutspourprisesmurales pourgazmdicauxcomprimsetpourlevide(aspiration) RohrleistungssystemefrmedizinischeGaseTeil6: MaeundZuordnungvonSteckernfrEntnahmestellenfr medizinischeDruckgaseundVakuu

13、m ThisEuropeanPrestandard(ENV)wasapprovedbyCENon18December2002asaprospectivestandardforprovisionalapplication. TheperiodofvalidityofthisENVislimitedinitiallytothreeyears.AftertwoyearsthemembersofCENwillberequestedto submittheir comments,particularlyonthequestionwhethertheENVcanbeconvertedintoaEurope

14、anStandard. CENmembersarerequiredtoannouncetheexistenceofthisENVinthesamewayasforanENandtomaketheENVavailablepromp tly atnationallevelinanappropriateform.Itispermissibletokeepconflictingnationalstandardsinforce(inparalleltothe ENV)untilthefinal decisionaboutthepossibleconversionoftheENVintoanENisrea

15、ched. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMAL

16、ISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENV7376:2003EENV7376:2003(E) 2 Contents page Foreword3 Introduction .4 1 Scope 5 2 Normativereferences 5 3 Termsandd

17、efinitions. .6 4 Usesofprobes .7 5 Dimensions.7 6 Allocation7 Bibliography 14ENV7376:2003(E) 3 Foreword Thisdocument(ENV7376:2003)hasbeenpreparedbyTechnicalCommitteeCEN/TC215“Respiratoryand anaestheticequipment“thesecretariatofwhichisheldbyBSIasaSpecialStatusEuropeanPrestandard(ENV). EN737consistsof

18、thefollowingPartsunderthegeneraltitle“Medicalgaspipelinesystems”: Part1: Terminalunitsforcompressedmedicalgasesandvacuum Part2: AnaestheticgasscavengingdisposalsystemsBasicrequirements Part3: Pipelinesforcompressedmedicalgasesandvacuum Part4: Terminalunitsforanaestheticgasscavengingsystems Part6: Di

19、mensionsandallocationofprobesforterminalunitsforcompressedmedicalgasesandvacuum Takingintoaccountthat: thereareCENmembercountriesusingterminalunitsandprobeswhichcomplywithEN7371andwhich havedimensionsofprobescomplyingwiththenationalstandardsofAustria(NORM7387series),France (AFNORNFS90116),Germany(DI

20、N13260,Teil2),Italy(UNI9507),Sweden(SS8752430)andUnited Kingdom(BS5682); thereareCENmembercountriesusingterminalunitsandprobesofexistingproprietarydesignwhich complywithEN7371andwhichhavepublishedgasspecificdimensionsandtolerances; someofthesenationalstandardsandproprietarydesignshaveaspecialstatusd

21、efinedbylawor regulationandcannotthereforebechangedorwithdrawn; thisdocumentispublishedasaSpecialStatusEuropeanPrestandard(ENV)forthefollowingreasons: CENmemberswillnotbeboundtoimplementtheENV;theyneedonlymaketheENVavailableatnational levelintheformofe.g.“Draftfordevelopment“; thedimensionsofprobesg

22、ivenintheconflictingnationalstandardslistedabovewillnotbewithdrawnandmay bekeptinforceinparalleltothosegivenintheEuropeanPrestandard; terminalunitsandprobeswhichcomplywithEN7371andwhichhavedimensionscomplyingwiththe conflictingnationalstandardslistedabovemaycontinuetobeinstalledandusedforbothnewinst

23、allationsand extensionsofexistinginstallationsasspecifiedbyappropriateNationalAuthorities; terminalunitsandprobesofexistingproprietarydesignwhichcomplywithEN7371,whichhavepublished gasspecificdimensionsandtolerancesmaycontinuetobeinstalledandusedforbothnewinstallationsand extensionsofexistinginstall

24、ationsasspecifiedbyappropriateNationalAuthorities,providedthatitisneither possibleforprobescomplyingwithENV7376tolockintoand/orreleasegasfromsocketscomplyingwith eachproprietarydesignnorpossibleforprobescomplyingwitheachproprietarydesigntolockintoandto releasegasfromsocketscomplyingwithENV7376; itwi

25、llbepossibletoinstallanduseterminalunitsandprobescomplyingwithEN7371andthisEuropean PrestandardforfieldtrialsinhealthcarefacilitiesbyagreementwithappropriateNationalAuthorities. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoannounceth

26、isEuropeanPrestandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal, Slovakia,Spain,Sweden,SwitzerlandandtheUnitedKingdom.ENV7376:2003(E) 4 Introduction Terminalunitsarethepointsonamedicalgassupplysyste

27、mwheretheoperatormakesconnectionsand disconnectionsforthesupplyofspecifiedmedicalgasestoanaestheticmachines,lungventilatorsorotheritemsof medicalequipment,andwhereawrongconnectioncancreateahazardtothelifeofapatient.Connectionof medicalequipmenttoaterminalunitismadebyinsertingagasspecificprobeintoaga

28、sspecificconnectionpoint ontheappropriateterminalunit.Boththeprobeandtheterminalunitarebegasspecifictoensurethatthecorrect gasisdeliveredtothemedicalequipment. Itisimportantthereforethatprobesandthecorrespondinggasspecificconnectionpointsaredesignedand manufacturedinsuchawayastomeettherequirementssp

29、ecifiedinthisEuropeanPrestandard. ThisEuropeanPrestandardgivesthedimensionsandallocationofprobesandthecorrespondinggasspecific connectionpoints,inordertoensurethatonlyonedesignofprobeisusedforeachspecifiedmedicalgas.ENV7376:2003(E) 5 1Scope ThisEuropeanPrestandardspecifiesthedimensionsandallocationo

30、fprobesintendedtobeconnectedtoterminal unitsofmedicalgaspipelinesystemsspecifiedinEN7373forusewiththefollowingmedicalgases: oxygen; nitrous oxide; medical air; carbon dioxide; oxygen/nitrousoxidemixture(50/50%V/V); airfordrivingsurgicaltools; nitrogenfordrivingsurgicaltools; vacuum. Itisintendedtoen

31、surethatonlygasspecificprobesareusedsoastopreventwrongconnectionofprobesto terminalunitsfordifferentgases. ThisEuropeanPrestandardspecifiesthedimensionsoftheprobeintendedtobeconnectedtoterminalunitsof medicalgaspipelinesystemsspecifiedinEN7373forsupplyanddisposalofairfordrivingsurgicaltools. ThisEur

32、opeanPrestandardspecifiesthedimensionsandallocationofeachgasspecificconnectionpoint. ThisEuropeanPrestandarddoesnotspecifythedimensionsofNISTconnectors.Thesedimensionsaregivenin EN739. ThisEuropeanPrestandarddoesnotspecifythedimensionsofprobesintendedtobeconnectedtoterminalunits foranaestheticgassca

33、vengingsystems.ThesedimensionsaregiveninEN7374. ThisEuropeanPrestandarddoesnotspecifythesuitabilityofmaterial,cleanliness,testing,gasspecificity, identificationandinformation.ThesearespecifiedinEN7371whichalsoappliestoprobesandgasspecific connectionpoints. 2 Normativereferences ThisEuropeanPrestanda

34、rdincorporates,bydatedorundatedreferences,provisionsfromotherpublications. Thesenormativereferencesarecitedattheappropriateplacesinthetext,andthepublicationsarelistedhereafter. Fordatedreferences,subsequentamendmentstoorrevisionofanyofthesepublicationsapplytothisEuropean Prestandardonlywhenincorpora

35、tedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferredtoapplies(includingamendments). EN202861, ISOsystemoflimitsandfitsPart1:Basesoftolerances,deviationsandfits(ISO2861:1988).ENV7376:2003(E) 6 3 Termsanddefinitions ForthepurposesofthisEuropeanPrestandard,thefollo

36、wingtermsanddefinitionsapply. 3.1 gasspecific havingcharacteristicswhichpreventinterchangeabilityandtherebyallowassignmenttoonegasorvacuumservice only 3.2 gasspecificconnectionpoint thatpartofthesocketwhichisthereceptorforagasspecificprobe 3.3 medicalgas anygasormixtureofgasesintendedtobeadministere

37、dtopatientsfortherapeutic,diagnosticorprophylactic purposes,orforsurgicaltoolapplication 3.4 medicalgaspipelinesystem centralsupplysystemwithcontrolequipment,apipelinedistributionsystemandterminalunitsatthepointswhere medicalgasesorvacuumcanberequired 3.5 medicalgassupplysystem either amedicalgaspip

38、elinesystem;or anyotherinstallationhavingnopermanentpipelinesystembutemployingamedicalgassupplysourcecomplete withpressureregulators 3.6 NIST(noninterchangeablescrewthreaded)connector rangeofmaleandfemalecomponentsintendedtomaintaingasspecificitybytheallocationofasetofdifferent diametersandaleftorri

39、ghthandscrewthreadtothematingcomponentsforeachparticulargas 3.7 probe noninterchangeablemalecomponentdesignedforacceptancebyandretentioninthesocket 3.8 socket thatpartofaterminalunitwhichiseitherintegralorattachedtothebaseblockbyagasspecificinterfaceand whichcontainsthegasspecificconnectionpoint 3.9

40、 terminalunit outletassembly(inletforvacuum)ofamedicalgassupplysystematwhichtheoperatormakesconnectionsand disconnectionsENV7376:2003(E) 7 3.10 terminalunitforsupplyanddisposalofairfordrivingsurgicaltools combinationofanoutletassembly(forsupply)andaninletassembly(fordisposal)whichareconnectedtoasupp

41、ly systemandtoadisposalsystemrespectivelyandatwhichtheoperatormakesconnectionsanddisconnectionsby meansofacombinedprobe 4 Usesofprobes TypicalexamplesoftheuseofprobesaregiveninFigure1. 5Dimensions 5.1 DimensionsofprobesforcompressedmedicalgasesandvacuumshallcomplywithFigure2 andTable1. 5.2 Dimension

42、sofgasspecificconnectionpointsforcompressedmedicalgasesandvacuumshallcomplywith Figure3andTable2. 5.3 DimensionsoftheprobeforsupplyanddisposalofairfordrivingsurgicaltoolsshallcomplywithFigure4. NOTE ThesedimensionsarebasedonthoseinEDIN13260,Teil3. 5.4 Dimensionsofthegasspecificconnectionpointforsupp

43、lyanddisposalofairfordrivingsurgicaltoolsshall complywithFigure5. 5.5 Compliancewith5.1to5.4shallbeverifiedbymeasurement. 6Allocation 6.1 Allocationofprobesandgasspecificconnectionpointsforcompressedmedicalgasesandvacuumshall complywithTable3. 6.2 Compliancewith6.1shallbeverifiedbyvisualinspection.E

44、NV7376:2003(E) 8 Table1DiametersofprobesinFigure2 Dimensionsinmillimetres Probenumber A a (c9) B a (c9) 1 12,5 15,5 2 11,5 16,5 3 10,5 17,5 4 9,5 18,5 5 8,5(f7) 19,5 a TolerancesshallbeinaccordancewithEN202861. Table2DiametersofgasspecificconnectionpointsinFigure3 Dimensionsinmillimetres Gasspecific connectionpointnumber C a (H1