CEN TS 14507-2-2003 Inhalational nitric oxide systems Part 2 Supply systems《氧化氮吸入系统 第2部分 供应系统》.pdf

1、DRAFT FOR DEVELOPMENT DD CEN/TS 14507-2:2003 Inhalational nitric oxide systems Part 2: Supply systems ICS 11.040.10 DD CEN/TS 14507-2:2003 This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 11 April 2003 BSI 11 April 2003 ISBN 0 580 41537 6

2、 National foreword This Draft for Development reproduces verbatim CEN/TS 14507-2:2003. This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature because nitric oxide is a relatively new medical

3、gas. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the European organization responsible for its conve

4、rsion to a European standard. A review of this publication will be initiated 2 years after its publication by the European organization so that a decision can be taken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the a

5、ppropriate issue of Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into a European standard, to extend the life of the Technical Specification or to withdraw it. Comments should be sent

6、in writing to the Secretary of BSI Subcommittee CH/121/6, Medical gas supply systems, at British Standards House, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list of organizations represe

7、nted 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 Correspondence Index”,

8、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 CEN/TS title page, pages 2 to 15 and a back cover. The BSI copyright date displayed in this document indicates when the

9、 document was last issued. Amendments issued since publication Amd. No. Date CommentsTECHNICALSPECIFICATION SPCIFICATIONTECHNIQUE TECHNISCHESPEZIFIKATION CEN/TS145072 March2003 ICS11.040.10 Englishversion InhalationalnitricoxidesystemsPart2:Supplysystems InhalationssystemefrSti ckstoffmonoxidTeil2:

10、Versorgungssysteme ThisTechnicalSpecification(CEN/TS)wasapprovedbyCENon02November2002forprovisionalapplication. TheperiodofvalidityofthisCEN/TSislimitedinitiallytothreeyears.AftertwoyearsthemembersofCENwillberequested tosubmittheir comments,particularlyonthequestionwhethertheCEN/TScanbeconvertedinto

11、aEuropeanStandard. CENmembersarerequiredtoannouncetheexistenceofthisCEN/TSinthesamewayasforanENandtomaketheCEN/TSavailable .It ispermissibletokeepconflictingnationalstandardsinforce(inparalleltotheCEN/TS)untilthefinaldecisionaboutthep ossible conversionoftheCEN/TSintoanENisreached. CENmembersarethen

12、ationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMI

13、TEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.CEN/TS145072:2003ECEN/TS145072:2003(E) 2 Contents Page Foreword. 3 INTRODUCTION 3 1 Scope 4 2 Normativereferences . 4 3 Termsanddefinitions

14、. 5 4 Terminology. 5 5 Generalrequirements . 5 5.1 RSafety. 5 5.2 RAlternativeconstruction . . 5 5.3 Materials. 5 6 Designrequirements . . 6 6.1 Componentsofthesupplysystemsfornitricoxide . 6 6.2 Cylinders 6 6.3 RCylindervalves . 7 6.4 RPressureregulators 7 6.5 Pressuregauges . 7 6.6 RHighpressurefl

15、exibleconnections . 7 6.7 RLowpressurehoseassemblies . . 8 6.8 Outletconnectorofthesupplysystem . . 8 6.9 Quickconnectors 8 6.10 Outletpressure 8 6.11 Alarms 8 6.12 Flow 8 6.13 Leakage 9 6.14 RChangeover. . 9 6.15 RPurging . . 9 6.16 RSupportingstructure 9 6.17 RStability. . 9 6.18 RRailsystem. . 9

16、6.19 RElectricalcomponents . 9 6.20 Backuppowersupply. . 10 7 Constructionalrequirements. 10 7.1 RCleaning. 10 7.2 RLubricants . 10 8 Testmethods . 10 8.1 Ambientconditions . 10 8.2 Typetestsofcomponents 10 8.3 Productiontestsofthesupplysystem. 10 9 Markingandpackaging . 11 9.1 Marking. 11 9.2 Packa

17、ging 11 10 Informationtobesuppliedbythemanufacturer . 11 AnnexARationale(Informative) . 14 Bibliography . 15CEN/TS145072:2003(E) 3 Foreword Thisdocument(CEN/TS145072:2003)hasbeenpreparedbyTechnicalCommitteeCEN/TC 215 “Respiratoryandanaestheticequipment”,thesecretariatofwhichisheldbyBSI. Thisdocument

18、hasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandthe EuropeanFreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s). CEN/TS14507consistsofthefollowingPartsunderthegeneraltitle“Inhalationalnitricoxidesystems“ Part1Deliverysystems Part2Supplysystems Attentionisdrawntother

19、ationalesandguidanceonequipmentforusewithnitricoxidegiveninCR13903 AnnexAofthisEuropeanTechnicalSpecificationisgivenforinformationandcontainsrationalestatements forthisEuropeanTechnicalSpecification.Theclauseswhichhavecorrespondingrationalestatementsare markedwithR)aftertheirnumber. AccordingtotheCE

20、N/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoanouncethisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark, Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands, Norway,Portugal,Slovakia,Spain,Sweden,Switzerla

21、ndandtheUnitedKingdom. INTRODUCTION Supplysystemsfornitricoxide/nitrogenmixturesareusedtoprovideacontinuousflowofgastodeliveryand monitoringsystemswhichcomplywithCEN/TS145072.Thecomponentsofthesystemcaneitherbe attachedtoamobiletrolleyorfixedtoapermanentstructuresuchasawall.Sincenitricoxidereacts sp

22、ontaneouslywithambientoxygentoformtoxicproducts,itisimportanttopreventtheingressofairintothe supplysystemandalsotoprovideameansofpurgingthesupplysystembeforeuse.Leakagetoatmosphere shouldalsobekepttoaminimum.Continuityofsupplycanbeobtainedbytheprovisionoftwocylinderswith analarmforlowcylinderpressur

23、eandameansofchangeoverfromonecylindertoanother.Inorderto ensuretraceabilityofthegassupply,onlyonecylindershouldbeinuseatthesametime.Itisessentialthat regularinspectionandmaintenanceareundertakentoensurethatthesupplysystemscontinuetomeetthe requirementsofthisPartofCEN/TS14507. ThisPartofCEN/TS14507pa

24、ysparticularattentionto: Continuityofsupply Suitabilityofmaterialsandcomponents Safety(mechanicalstrength,releaseofexcesspressure,leakageandstability) Gasspecificity Cleanliness Testing Identification Informationsupplied(includingproceduresforpurgingandreplacementofcylinders)CEN/TS145072:2003(E) 4 1

25、Scope 1.1 ThisPartofCEN/TS14507appliestosystemsforthesupplyofnitricoxide/nitrogenmixturestoa deliveryandmonitoringsystemcomplyingwithCEN/TS145071fortreatmentofonepatientatatime,ina healthcarefacility. 1.2 ThisPartofCEN/TS14507appliestosupplysystemswithcylindersatafillingpressureupto20000 kPaandconce

26、ntrationsupto1000l/lofnitricoxideinnitrogen. 1.3 RThisPartofCEN/TS14507doesnotapplyto: pipelinesystemsfordeliveryofnitricoxide/nitrogenmixturestomorethanonepatientatatime; supplysystemsfornitricoxide/nitrogenmixturesintendedforuseinhomecare,emergencyandtransport. 2 Normativereferences ThisTechnicalS

27、pecificationincorporates,bydatedorundatedreference,provisionsfromotherpublications. Thesenormativereferencesarecitedattheappropriateplacesinthetextandthepublicationsarelisted hereafter.Fordatedreferences,subsequentamendmentstoorrevisionofanyofthesepublicationsapplyto thisTechnicalSpecificationonlywh

28、enincorporatedinitbyamendmentorrevision.Forundatedreferences thelatesteditionofthepublicationreferredtoapplies(includingamendments). EN7381:1997+A1:2001,PressureregulatorsforusewithmedicalgasesPart1:Pressureregulatorsand pressureregulatorswithflowmeteringdevices(includingAmendment1:2001) EN7383:1998

29、+A1:2001,PressureregulatorsforusewithmedicalgasesPart3:Pressureregulators integratedwithcylindervalves EN739:1998+A1:2001,Lowpressurehoseassembliesforusewithmedicalgases EN8371,PressuregaugesPart1:BourdontubepressuregaugesDimensions,metrology,requirements andtesting EN962,GascylindersValveprotection

30、capsandvalve guardsforindustrialandmedicalgascylinders Design,constructionandtests EN1441,MedicaldevicesRiskanalysis EN12218,Railsystemsforsupportingmedicalequipment EN13221:2000,Highpressureflexibleconnectionsforusewithmedicalgases EN606011:1990,MedicalelectricalequipmentPart1:Generalrequirementsfo

31、rsafety(IEC606012:1988) EN6060112,MedicalelectricalequipmentPart1:GeneralrequirementsforsafetyElectromagnetic compatibility(IEC6060112:2001) prENISO407:2001,SmallmedicalgascylindersYoketypevalveconnections(ISO/DIS407:2001) prENISO10297:2002,TransportablegascylindersCylindervalvesSpecificationandtype

32、testing(ISO/DIS 10297:2002) ISO/DIS5145:2001,CylindervalveoutletsforgasesandmixturesSelectionanddimensioningCEN/TS145072:2003(E) 5 3 Termsanddefinitions ForthepurposesofthisTechnicalSpecificationthefollowingtermsanddefinitionsapply: 3.1 lowpressurehoseassembly assemblywhichconsistsofaflexiblehosewit

33、hpermanentattachedgasspecificinletandoutletconnectors whichisdesignedtoconductamedicalgasatpressuresbetween300kPaand1400kPaandforusewith vacuumserviceatpressuresabove10kPaabsolutepressure 3.2 quickconnector pairofnonthreadedgasspecificcomponentswhichcanbeeasilyandrapidlyjoinedtogetherbyasingle actio

34、nofoneorbothhandswithouttheuseoftools 3.3 singlefaultcondition conditioninwhichasinglemeansforprotectionagainstasafetyhazardinequipmentisdefectiveorasingle externalabnormalconditionispresent 4Terminology AtypicalexampleofanitricoxidesupplysystemwithexamplesofterminologyisgiveninFigure1. 5 Generalreq

35、uirements 5.1RSafety Supplysystemsfornitricoxide/nitrogenmixturesshall,whentransported,stored,installed,operatedinnormal useandmaintainedaccordingtotheinstructionsofthemanufacturer,causenosafetyhazardwhichcouldbe foreseenusingriskanalysisproceduresinaccordancewithEN1441andwhichisconnectedwiththeir i

36、ntendedapplication,innormalconditionandinsinglefaultcondition. Inparticulartheriskanalysisshalladdressthepossibleconsequencesofacatastrophicreleaseoftheentire contentsofacylinderofnitricoxide/nitrogenmixture. Evidenceshallbeprovidedbythemanufacturer. 5.2RAlternativeconstruction Supplysystemsfornitri

37、coxide/nitrogenmixturesandcomponentsorpartsthereof,usingmaterialsorhaving formsofconstructiondifferentfromthosedetailedinclauses5and6ofthisPartofCEN/TS14507shallbe acceptedifitcanbedemonstratedthatanequivalentdegreeofsafetyisobtained. Suchevidenceshallbeprovidedbythemanufacturer. 5.3Materials 5.3.1

38、Thematerialsincontactwiththegasshallbecorrosionresistantandcompatiblewithnitric oxide/nitrogenmixtures(uptoaconcentrationof1000l/lofnitricoxideinnitrogen)inthetemperaturerange specifiedin5.3.2. NOTE1 Corrosionresistanceincludesresistanceagainstmoistureandsurroundingmaterials.CEN/TS145072:2003(E) 6 N

39、OTE2 Althoughduringnormaloperationnocomponentofthesupplysystemsoughttobecomecontaminatedwith oxygenandmoisture,experiencehasshownthatsuchcontaminationis possible. Nitric oxide reacts spontaneously withoxygen(air)formingnitrogendioxide.Inthepresenceofwater,nitrogendioxideformsnitricacid(HNO 3 )andnit

40、rous acid(HNO 2 )thatcanreactwithmaterialsusedforcomponentsofthesupplysystemandcausecorrosion. 5.3.2 Thematerialsshallpermitthesupplysystemsfornitricoxide/nitrogenmixturesandtheircomponents tomeettherequirementsofclause6inthetemperaturerangeof+10Cto+40C. 5.3.3 Thesupplysystemsfornitricoxide/nitrogen

41、mixturesshallbecapable,whilepackedfortransportand storage,ofbeingexposedtoenvironmentalconditionsasstatedbythemanufacturer. 5.3.4 Springs,highlystrainedcomponentsandpartsliabletowearwhichcomeincontactwiththegasshall notbeplated. NOTE Platingcouldcomeoff. 5.3.5 REvidenceofconformitywiththerequirement

42、sofclauses5.3.1to5.3.4shallbeprovidedbythe manufacturer. 6Design requirements NOTE ThecriteriatobeobservedinthedesignphasearedescribedinSection4ofCENReportCR13903:2000. 6.1Componentsofthesupplysystemsfornitricoxide Supplysystemsfornitricoxide/nitrogenmixturesshallcomprisethefollowing: a) twoormorecy

43、linderseachfittedwithcylindervalve; b) twoormorepressureregulators; c) onehighpressuregaugeforeachcylindertoindicatethegascontents; d) atleastonelowpressuregaugetoindicatetheoutletpressuresuppliedtothedeliverysystem; e)one outlet connector; f) oneminimumpressurealarmforthecylinderinuse; g) onebackup

44、powersupply(ifelectricallyoperatedcomponentsarefitted); h) meansforchangeoverfromonecylindertoanother; i) meansforpurgingofthesystem. Allcomponentsshallbesecuredtoasupportingstructuree.g.amobiletrolleyorawall. NOTE1 Thesupplysystemcanbeprovidedwitharailsystemforsupportingmedicalequipment. NOTE2 Thesupplysystemcanbeprovided