1、BRITISH STANDARD BS EN ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary The European Standard EN ISO 4135:2001 has the status of a British Standard ICS 11.040.10; 01.040.11 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN ISO 4135:2001 This British Standard,
2、having been prepared under the direction of the Health and Environmental Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 5 September 2001 BSI 5 September 2001 ISBN 0 580 38443 8 National foreword This British Standard is the o
3、fficial English language version of EN ISO 4135:2001. It is identical to ISO 4135:2001. It supersedes BS EN ISO 4135:1996 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee IH/3, Anaesthesiology (International), which has the responsibility to: A list of
4、 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 Standards Catalogue under the section entitled “International S
5、tandards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British St
6、andard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and Euro
7、pean developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to vi, pages 1 to 64, an inside back cover and a back cover. The BSI copyright date displayed
8、in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO4135 August2001 ICS01.040.11;11.040.10 SupersedesENISO4135:1996 Englishversion AnaestheticandrespiratoryequipmentVocabulary (ISO
9、4135:2001) Matrieldanesthsieetderanimationrespiratoire Vocabulaire(ISO4135:2001) AnsthesieundBeatmungsgerteBegriffe (ISO4135:2001) ThisEuropeanStandardwasapprovedbyCENon1August2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Stand
10、ardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra
11、nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Port
12、ugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO4135:200
13、1EINESO14:5302(10E) 2 Foreword ThetextoftheInternationalStandardISO4135:2001hasbeenpreparedbyTechnical CommitteeISO/TC121“Anaestheticandrespiratoryequipment“incollaborationwith TechnicalCommitteeCEN/TC215“Respiratoryandanaestheticequipment“,thesecretariat ofwhichisheldbyBSI. ThisEuropeanStandardsupe
14、rsedesENISO4135:1996. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublication ofanidenticaltextorbyendorsement,atthelatestbyFebruary2002,andconflictingnational standardsshallbewithdrawnatthelatestbyFebruary2002. ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe
15、European CommissionandtheEuropeanFreeTradeAssociation,andsupportsessentialrequirements ofEUDirective(s). AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France
16、,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom. Endorsementnotice ThetextoftheInternationalStandardISO4135:2001wasapprovedbyCENasaEuropean Standardwithoutanymodification. ENISO4135:2001 Reference number Numro de rfrence ISO
17、4135:2001(E/F) OSI 1002 INTERNATIONAL STANDARD NORME INTERNATIONALE ISO 4135 Third edition Troisime dition 2001-08-01 Anaesthetic and respiratory equipment Vocabulary Matriel danesthsie et de ranimation respiratoire Vocabulaire ENISO4135:2001 ISO 5314:(1002E/)F DPF dlcsiremia ihTs PDF file mya ctnoa
18、in emdeddeb tyfepcaes. In acccnadroe with Aebods licnesign lopic,y this file may be pirntde ro ivwede tub slahl ton eb ideted lnuess teh tyfepacse which aer emdeddeb era licnesed to dna intslaled on teh computre freporming teh idetign. In wodlnidaogn this f,eli trapies accept tniereh teh sersnoptili
19、biy of ton nifrgnigni Asebod licsnegni ilopcy. ehT ISO tneClar Secteraairt cacepts no lilibaity ni this .aera Aebod is a tedarmakr fo Aebod Stsyems Icntaropro.de teDails fo the sfotwera pcudorts sude to crtaee tihs PFD file can be fdnuo in the Glarene Info leratiev to the fil;e the Pc-FDaertion arap
20、mteres were tpoimizde for pirtning. Evyre cera sah neeb taken to enseru taht teh file is suitlbae fro sue by ISO memreb idob.se In teh lnuikley etnev ttah a plborem leratign to it is f,dnuo lpsaee ifnrom teh tneClar Sceterairat at the sserdda givne lebwo. FDP noxEnoitar de serbasnoptili eL rpstne fi
21、chier PFD tuep ctnoiner des lopices ed catcarser itnrg.se Cfnorommtne xua cidnotinos de licnece dA,ebod ce fichier uept rte imprim uo ivslauis, mias ne iodt sap rte modiifmoins euq lidroantrue emlpyoect eefft ne bnficie denu licence tuairostna ltuilisatino ed ces lopicse te euq celles-ci y siotne in
22、tslales. roLs du tlcegrahmtne ed ce fichie,r les parties concnrese acctpetne ed fait la sersnopibalit ed en sap fneiererdn les cidnotinos de liccnee dA.ebod eL Secrtairta ctnelar de lISO dlcine ttuoe rsesnopibalit ne la amti.er Aebod tse enu maeuqr dsope dAebod Stsyems Icntaropro.de seL dtails rleta
23、ifs xua iudorpts ligociles utiliss ruop la cra t i o dn pu r stne fichier PFD stno idsinoplbes nads la rirbueuq lareneG Info ud cifheir; els paramtrse ed crtaion PFD not t optmisis ruop limsserpi.no uoTtse les messeru tno t prisse ruop tnaragir lxelpiotatino ed ec ifhcier par les comits memserb ed l
24、ISO. naDs le cas uep lbaborpe o suivriardnet un plborme dutliisatoin, veuelliz en informer le eSrctairat ctnelar lerdasse nnode ci-deossus. ISO 1002 ehT rcudorpetino of the trems dna fedinitions ctnoiaden in this Intetanrilano Stdradna is repmitted in tihcaegn mlauna,s intscurtion kooblets, tecinhca
25、l lbupicatisno dna jlanruos fro tsirtcly udecatilano ro implemtneation soprupes. Teh cidnotisno for such rcudorpetino :era ttah on midoficatinos aer meda to the tmres dna fedinitions; ttah such cudorpertino is ton repmittde for dictiiranoes or similar lbupictaions offeder fro sale; dna that this Int
26、etanrilano Stdradna is rfecnerede as the scruoe codumnet. With the sloe exctpeisno tonde ,evoba on toreh trap of tihs lbupictaion mya eb cudorperde ro tuilizde in yna form ro yb yna m,snae eletcinorc or mecinahcal, inlcidugn tohpociypong dna microfilm, wittuoh repmissino in writing form eitreh ISO a
27、t teh sserdda lebwo ro ISOs memreb ydob in the cnuotry of teh tseuqere.r aL cudorpertino eds tremes et sed dfiintisno ctnosune snad la rpstnee Nrome intetanrilanoe est uatoirse snad les mleunas densiemengnet, les msedo demlpio, lse lbupicatisno te seuver tecinheuqs destins excluisevmtne lneseiengmtn
28、e uo la mise ne lppaictai.no eLs cidnotisno denu telle cudorpertino stno les siutnav:se aucenu midoficatino nest troppae xua termse te dfiinti;sno la rcudorpetino ntse pas uatoirse snad sed idctiiannoers ou lbupicatisno ismilairse edstins la tnev;e la rpsente Nrome intetanrilanoe ets cite comme codu
29、mnet scruoe. la sluee exctpeion mnetinnoe ci-edss,su aucenu trapie de ctete lbupictaion ne tuep tre riudorpete ni tuilise ssuo leuqeuq forme euq ce soit te rap cuanu corpd, lectinoreuq uo mcinaeuq, y compirs la tohpipocoe et les micrfoilms, ssna laccodr rcit de lOSI lserdase cirpa-os u ud comit memb
30、er ed lISO snad le syap du dem.ruedna ISO cirypothg fofice saCe tsopale 65 1121-HC aveneG 20 leT. + 41 22 947 10 11 xaF + 14 22 947 90 74 E-mail cirypothgiso.ch eWb www.iso.ch ii ENISO4135:2001 iii Contents Page Scope .1 1 Medical gas supply systems 2 2 Anaesthetic machines and workstations for use
31、with humans10 3 Ventilators and resuscitators .12 4 Breathing systems.24 5 Humidifiers, nebulizers and moisture exchangers 31 6 Airways, tracheal tubes, tracheostomy tubes and intubation equipment.37 7 Anaesthetic gas scavenging systems.42 8 Suction devices43 9 Monitoring 47 Alphabetical index 56 EN
32、ISO4135:2001 iv Sommaire Page Domaine dapplication1 1 Systmesdedis tr ibutiondega zm dicaux 2 2 Appareils danesthsie et systme danesthsie pour utilisation chez lhomme .10 3 Ventilateurs et ressuscitateurs.12 4 Systmes respiratoires .24 5 Humidificateurs, nbuliseurs et changeurs dhumidit.31 6V o i e
33、s a riennes, sondes trachales, canules de trachotomie et matriel dintubation.37 7 Systmes dvacuation des gaz danesthsie 42 8 Dispositifs daspiration .43 9 Monitorage47 Index alphabtique .59 ENISO4135:2001 v Foreword ISO (the International Organization for Standardization) is a worldwide federation o
34、f national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. In
35、ternational organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with
36、the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to
37、the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 4135 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory e
38、quipment, Subcommittee SC 4, Anaesthesia terminology. This third edition cancels and replaces the second edition (ISO 4135:1995), of which it constitutes a technical revision. ENISO4135:2001 vi Avant-propos LISO (Organisation internationale de normalisation) est une fdration mondiale dorganismes nat
39、ionaux de normalisation (comits membres de lISO). Llaboration des Normes internationales est en gnral confiea u x comits techniques de lISO. Chaque comit membre intress par une t u d eal ed r o i td ef a i r ep a r t i ed uc o m i t technique cr cet effet. Les organisations internationales, gouverne
40、mentales et non gouvernementales, en liaison avec lISO, participent galement aux travaux. LISO collabore troitement avec la Commission lectrotechnique internationale (CEI) en ce qui concerne la normalisation lectrotechnique. Les Normes internationales sont rdiges conformment aux rgles donnes dans le
41、s Directives ISO/CEI, Partie 3. Les projets de Normes internationales adopts par les comits techniques sont soumis aux comits membres pour vote. Leur publication comme Normes internationales requiert lapprobation de 75 % au moins des comits membres votants. Lattention est appele sur le fait que cert
42、ains des lm e n t sd el ap r sente Norme internationale peuvent faire lobjet de droits de proprit intellectuelle ou de droits analogues. LISO ne saurait tre tenue pour responsable de ne pas avoir identifi de tels droits de proprit et averti de leur existence. La Norme internationale ISO 4135 a t labore par le comit technique ISO/TC 121, Matriel danesthsie et de ranimation respiratoire, sous-comit SC 4, Terminologie concernant lanesthsie. Cette troisime dition annule et remplace la deuxime dition (ISO 4135:1995), dont elle constitue une rvision technique. ENISO4135:2001
