1、DRAFT FOR DEVELOPMENT DD CEN/TS 14507-1:2003 Inhalational nitric oxide systems Part 1: Delivery systems ICS 11.040.10 DD CEN/TS 14507-1:2003 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 41536
2、 8 National foreword This Draft for Development reproduces verbatim CEN/TS 14507-1:2003. 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 medica
3、l 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 con
4、version 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
5、 appropriate 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 sen
6、t in writing to the Secretary of BSI Subcommittee CH/121/1, Breathing attachments and anaesthetic machines, 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
7、 organizations 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 C
8、orrespondence 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 CEN/TS title page, pages 2 to 26, an inside back cover and a back cover. The BSI copyright date d
9、isplayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsTECHNICALSPECIFICATION SPCIFICATIONTECHNIQUE TECHNISCHESPEZIFIKATION CEN/TS145071 March2003 ICS11.040.10 Englishversion InhalationalnitricoxidesystemsPart1:Deliverysystems
10、 InhalationssystemefrSti ckstoffmonoxidTeil1: Abgabesysteme ThisTechnicalSpecification(CEN/TS)wasapprovedbyCENon02November2002forprovisionalapplication. TheperiodofvalidityofthisCEN/TSislimitedinitiallytothreeyears.AftertwoyearsthemembersofCENwillberequested tosubmittheir comments,particularlyontheq
11、uestionwhethertheCEN/TScanbeconvertedintoaEuropeanStandard. CENmembersarerequiredtoannouncetheexistenceofthisCEN/TSinthesamewayasforanENandtomaketheCEN/TSavailable .It ispermissibletokeepconflictingnationalstandardsinforce(inparalleltotheCEN/TS)untilthefinaldecisionaboutthep ossible conversionoftheC
12、EN/TSintoanENisreached. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION CO
13、MITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.CEN/TS145071:2003ECEN/TS145071:2003(E) 2 Contents Page Foreword. 4 Sectionone General 4 1 Scope 4
14、2 Normativereferences . 5 3 Termsanddefinitionsandterminology. . 6 4 Generalrequirementsandrequirementsfortests 6 4.1 Modificationstoclause3oftheGeneralStandard . 6 4.2 Modificationtoclause4oftheGeneralStandard .7 5 Classification. 7 6 Identification,markinganddocuments . . 7 6.1 Markingontheoutside
15、ofequipmentorequipmentparts . 7 7 PowerInput. . 9 Sectiontwo Environmentalconditions .9 8 Basicsafetycategories . . 9 9 Removableprotectivemeans 9 10 Environmentalconditions . . 9 11 Notused. 9 12 Notused. 9 Sectionthree Protectionagainstelectricalshockhazards 9 13 General . 9 14 Requirementsrelated
16、toclassification . 9 15 Limitationofvoltageand/orenergy 9 16 Enclosuresandprotectivecovers. 10 17 Separation 10 18 Protectiveearthing,functionalearthingandpotentialequalization 10 19 Continuousleakagecurrentandpatientauxiliarycurrent . 10 20 Dielectricstrength . 10 Sectionfour Protectionagainstmecha
17、nicalhazards 10 21 Mechanicalstrength . 10 22 Movingparts. . 11 23 Surfaces,corners,andedges. . 11 24 Stabilityinnormaluse 11 25 Expelledparts. . 11 26 Vibrationandnoise . 11 27 Pneumaticandhydraulicpower 11CEN/TS145071:2003(E) 3 28 Suspendedmasses . . 11 Sectionfive Protectionagainsthazardsfromunwa
18、ntedorexcessiveradiation. 12 29 XRadiation 12 30 Alpha,beta,gamma,neutronradiationandotherparticleradiation 12 31 Microwaveradiation . 12 32 Lightradiation(includinglasers) . . 12 33 Infraredradiation . 12 34 Ultravioletradiation. 12 35 Acousticalenergy(includingultrasonics) . 12 36 Electromagneticc
19、ompatibility . 12 Sectionsix Protectionagainsthazardsofignitionofflammablemixtures 13 Sectionseven Protectionagainstexcessivetemperaturesandothersafetyhazards 13 42 Excessivetemperatures. 13 43R) Fireprevention. . 13 44 Overflow,spillage,leakage,humidity,ingressofliquids,cleaning,sterilizationand di
20、sinfection 13 45 Pressurevesselsandpartssubjecttopressure. 1 4 46Human errors 14 47Electrostatic charges. .14 48Biocompatibility 14 49 Interruptionofthepowersupply. 14 Sectioneight Accuracyofoperationdataandprotectionagainstincorrectoutput . 15 50 Accuracyofoperatingdata 15 51 Protectionagainsthazar
21、dousoutput . 15 Sectionnine Abnormaloperationandfaultconditions Environmentaltests 17 52 Abnormaloperationandfaultconditions 17 53 Environmentaltests 17 Sectionten Constructionalrequirements. 17 54 General. 17 55 Enclosuresandcovers . 17 56 Componentsandgeneralassembly . 17 57 Mainsparts,componentsa
22、ndlayout . 18 58 Protectiveearthing Terminalsandconnections. 19 59 Constructionandlayout . 19 Annexes 22 AnnexAA(informative)Rationale . 23 Bibliography . 26CEN/TS145071:2003(E) 4 Foreword Thisdocument(CEN/TS145071:2003)hasbeenpreparedbyTechnicalCommitteeCEN/TC 215 “Respiratoryandanaestheticequipmen
23、t”,thesecretariatofwhichisheldbyBSI. ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandthe EuropeanFreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s). CEN/TS14507consistsofthefollowingPartsunderthegeneraltitle“Inhalationalnitricoxidesystems“ Part1Delivery
24、systems Part2Supplysystems AttentionisdrawntotherationalesandguidanceonequipmentforusewithnitricoxidegiveninCR13903 AnnexAAofthisPartofCEN/TS14507isgivenforinformationandcontainsrationalestatementsforthisPart ofCEN/TS14507.TheclauseswhichhavecorrespondingrationalestatementsaremarkedwithR)aftertheir
25、number. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoanouncethisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark, Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands, Norway,Portugal,Slovaki
26、a,Spain,Sweden,SwitzerlandandtheUnitedKingdom. Sectionone General 1Scope ThisPartofCEN/TS14507referstoEN606011:1990“MedicalelectricalequipmentPart1:General requirementsforsafety“,asamendedbyitsamendments1(1991)and2(1995).ForbrevityPart1isreferred tointhisPartofCEN/TS14507eitherastheGeneralStandardor
27、astheGeneralrequirements. Thescopegiveninclause1oftheGeneralStandardappliesexceptthat1.1isreplacedbythefollowing: 1.1 ThisPartofCEN/TS14507specifiesparticularrequirementsforinhalationalnitricoxidedeliverysystems andtheirmodules.Itcoversdeviceswhichcanbesuppliedincombinedunits,integratedintoanotherme
28、dical device,forexamplealungventilator,orasindividualdevices. ThisPartofCEN/TS14507addressesthemonitoringofnitricoxideandoxygendeliverytothepatientand minimizationoftheproductionofnitrogendioxide. ThisPartofCEN/TS14507coverstherequirementsforinhalationalnitricoxidedeliverysystemsintendedfor medicalu
29、se,forexample,incriticalcare,anaesthesia,andemergency/transportenvironments. NOTE Itisrecognizedthatfromtimetotimeinnovationsanddesignswillappearthatofferadvantagesand yetarenotcoveredbyspecificsafetyrelateddesignorperformanceaspectsofthisPartofCEN/TS14507; suchinnovationsarenottobediscouraged.Asthe
30、techniquesandtechnologiesintheseinnovations advance,itisessentialthatthesafetyobjectivesofthisPartofCEN/TS14507areconsideredasminimum requirements. Therequirementsofclause1.3oftheGeneralStandardapplywiththefollowingadditions: ThenumberingofclausesandsubclausesofthisPartofCEN/TS14507correspondstothat
31、oftheGeneral Standard.ThechangestothetextoftheGeneralStandardarespecifiedbytheuseofthefollowingwords:CEN/TS145071:2003(E) 5 ReplacementmeansthattheclauseorsubclauseoftheGeneralStandardisreplacedcompletelybythetext ofthisPartofCEN/TS14507. AdditionmeansthatthetextofthisPartofCEN/TS14507isadditionalto
32、therequirementsoftheGeneral Standard. AmendmentmeansthattheclauseorsubclauseoftheGeneralStandardisamendedasindicatedbythe textofthisPartofCEN/TS14507. SubclausesorfigureswhichareadditionaltothoseoftheGeneralStandardarenumberedstartingfrom101. AdditionalannexesareletteredAA,BB,etc.andadditionalitemsa
33、a),bb),etc. ThetermthisStandardisusedtomakereferencetotheGeneralStandardandthisPartofCEN/TS14507 takentogether. Wherethereisnocorrespondingsection,clauseorsubclauseinthisPartofCEN/TS14507,thesection, clauseorsubclauseoftheGeneralStandardapplieswithoutmodification. WhereitisintendedthatanypartoftheGe
34、neralStandard,althoughpossiblyrelevant,isnottobeapplied,a statementtothateffectisgiveninthisPartofCEN/TS14507. 2 Normativereferences ThisTechnicalSpecificationincorporatesbydatedorundatedreference,provisionsfromotherpublications. Thesenormativereferencesarecitedattheappropriateplacesinthetextandthep
35、ublicationsarelisted hereafter.Fordatedreferences,subsequentamendmentsapplytothisTechnicalSpecificationonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthepublication referredtoapplies(includingamendments). AppendixLofEN606011:1990applieswiththefollowingadditions:
36、 EN475,Medicaldevices Electricallygeneratedalarmsignals. EN7381:1997+A1:2001,Pressureregulatorsforusewithmedicalgases Part1:Pressureregulatorsand pressureregulatorswithflowmeteringdevices. EN7383:1998+A1: 2001, Pressure regulators for use with medical gases Part3:Pressureregulators integratedwithcyl
37、indervalves. EN739:1998+A1:2001,Lowpressurehoseassembliesforusewithmedicalgases. EN12598,Oxygenmonitorsforpatientbreathingmixtures Particularrequirements. EN13221,Highpressureflexibleconnectionsforusewithmedicalgases. EN60068264:1994, Environmental testing Part2:Testmethods TestFh:Vibration,broadban
38、d random(digitalcontrol)andguidance(IEC60068264:1993+Corrigendum1994. EN606011:1990+A1:1993+A2:1995, Medical electrical equipment Part1:Generalrequirementsfor safety(IEC606011:1998+A1:1991+A2:1995). EN6060112,Medicalelectricalequipment Part1:GeneralRequirementsforsafety2.Collateralstandard: Electrom
39、agneticcompatibility Requirementsandtests(IEC6060112:1993). EN 6100042,Electromagneticcompatibility(EMC)Part4:Testingandmeasurementtechniques Section2:Electrostaticdischargeimmunitytest BasicEMCpublication(IEC6100042:1995).CEN/TS145071:2003(E) 6 CEN/TS145072,Inhalationalnitricoxidesystems Part2:Supp
40、lysystems. ENISO4135,Anaestheticandrespiratoryequipment Vocabulary. IEC6006826:1995,Environmentaltesting Part2:Tests TestFc:Vibration(sinusoidal). IEC60068229:1987,Basicenvironmentaltestingprocedures Part2:Tests TestEbandguidance: Bump. IEC600794,Electricalapparatusforexplosivegasatmospheres Part4:M
41、ethodoftestforignition temperature. 3 Termsanddefinitionsandterminology ForthepurposesofthisTechnicalSpecification,clause2oftheGeneralStandardandENISO4135apply togetherwiththefollowingadditions: 3.1 inhalationalnitricoxidedeliverydevice 1) devicethatcontrolstheadditionofnitricoxidetothebreathinggas
42、NOTE Itcancontrolandindicateflow,concentrationordose. 3.2 inhalationalnitricoxidedeliverysystem 2) systemcomprisingnitricoxidedeliverydevice(s),monitoringandalarmdevice(s) 3.3 inhalationalnitricoxidedeliverysystemmonitoringdevice 3) devicethatdisplaysorindicatesthevaluesofvariablespertinenttothedeli
43、veryofnitricoxide NOTE Suchvariablescanberelatedtoe.g.oxygen,nitricoxideandnitrogendioxide. 4 Generalrequirementsandrequirementsfortests 4.1Modificationstoclause3oftheGeneralStandard Clause3oftheGeneralStandardapplieswiththefollowingadditions: 3.6 Additionalitems aa)shortandopencircuitsofcomponentso
44、rwiringwhichcanincreasetemperatures(seesectionseven); bb)anyfaultwhichisnotdetectedbyintrinsicmeansorbyperiodicinspection(e.g.anoxidantleak)shallbe regardedasanormalconditionandnotasinglefaultcondition; 1) Called“deliverydevice”withinthisPartofEN/TS14507. 2) Called“deliverysystem”withinthisPartofEN/TS14507. 3) Called“monitoringdevice”withinthi
