IEC 60601-3-1-1996 Medical electrical equipment - Part 3-1 Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure moni.pdf

1、NORME CE1 INTERNATIONALE INTERNATIONAL STANDARD IEC 601 -3-1 Premire dition First edition 1996-07 Appareils lectromdicaux - Partie 3-1 : Prescriptions essentielles de performances pour les appareils de surveillance de la pression partielle transcutane de loxygne et du dioxyde de carbone Medical elec

2、trical equipment - Part 3-1: Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment Numro de rfrence Reference number CEIAEC 601 -3-1 : 1996 Copyright International Electrotechnical Commission Provided by IHS under license with IECNot fo

3、r ResaleNo reproduction or networking permitted without license from IHS-,-,-Validit de la prsente publication Le contenu technique des publications de la CE1 est cons- tamment revu par la CE1 afin quil reflte ltat actuel de la technique. Des renseignements relatifs la date de reconfirmation de la p

4、ublication sont disponibles auprs du Bureau Central de la CEI. Les renseignements relatifs ces rvisions, ltablis- sement des ditions rvises et aux amendements peuvent tre obtenus auprs des Comits nationaux de la CE1 et dans les documents ci-dessous: Bulletin de la CE1 Annuaire de la CE1 Publi annuel

5、lement Catalogue des publications de la CE1 Publi annuellement et mis jour rgulirement Term i no log ie En ce qui concerne la terminologie gnrale, le lecteur se reportera la CE1 50: Vocabulaire Electrotechnique Infer- national (VEI), qui se prsente sous forme de chapitres spars traitant chacun dun s

6、ujet dfini. Des dtails complets sur le VE1 peuvent tre obtenus sur demande. Voir galement le dictionnaire multilingue de la CEI. Les termes et dfinitions figurant dans la prsente publi- cation ont t soit tirs du VEI, soit spcifiquement approuvs aux fins de cette publication. Symboles graphiques et l

7、ittraux Pour les symboles graphiques, les symboles littraux et les signes dusage gnral approuvs par la CEI, le lecteur consultera: - la CE1 27: Symboles liftraux utiliser en lectro- technique; - la CE1 417: Symboles graphiques utilisables sur le matriel. Index, relev et compilation des feuilles indi

8、viduelles; - la CE1 617: Symboles graphiques pour schmas; et pour les appareils lectromdicaux, - la CE1 878: Symboles graphiques pour quipe- ments lectriques en pratique mdicale. Les symboles et signes contenus dans la prsente publi- cation ont t soit tirs de la CE1 27, de la CE1 417, de la CE1 617

9、eou de la CE1 878, soit spcifiquement approuvs aux fins de cette publication. Publications de la CE1 tablies par le mme comit dtudes Lattention du lecteur est attire sur les listes figurant la fin de cette publication, qui numrent les publications de la CE1 prpares par le comit dtudes qui a tabli la

10、 prsente publication. Validity of this publication The technical content of IEC publications is kept under constant review by the IEC, thus ensuring that the content reflects current technology. Information relating to the date of the reconfirmation of the publication is available from the IEC Centr

11、al Office. Information on the revision work, the issue of revised editions and amendments may be obtained from IEC National Committees and from the following IEC sources: IEC Bulletin IEC Yearbook Catalogue of IEC publications Published yearly Published yearly with regular updates Terminology For ge

12、neral terminology, readers are referred to IEC 50: International Electrotechnical Vocabulary (IEV), which is issued in the form of separate chapters each dealing with a specific field. Full details of the IEV will be supplied on request. See also the IEC Multilingual Dictionary. The terms and defini

13、tions contained in the present publi- cation have either been taken from the IEV or have been specifically approved for the purpose of this publication. Graphical and letter symbols For graphical symbols, and letter symbols and signs approved by the IEC for general use, readers are referred to publi

14、cations: - IEC 27: Letter symbols to be used in electrical technology; - IEC 417: Graphical symbols for use on equipment. Index, survey and compilation of the single sheets; - IEC 617: Graphical symbols for diagrams, and for medical electrical equipment, - IEC 878: Graphical symbols for electromedic

15、al equipment in medical practice. The symbols and signs contained in the present publication have either been taken from IEC 27, IEC 417, IEC 617 and/or IEC 878, or have been specifically approved for the purpose of this publication. IEC publications prepared by the same technical committee The atte

16、ntion of readers is drawn to the end pages of this publication which list the IEC publications issued by the technical committee which has prepared the present publication. Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or netw

17、orking permitted without license from IHS-,-,-NORME INTERNATIONALE INTERNATIONAL STANDARD CE1 IEC 601 -3-1 Premire dition First edition 1996-07 Appareils lectromdicaux - Partie 3-1 : Prescriptions essentielles de performances pour les appareils de surveillance de la pression partielle transcutane de

18、 loxygne et du dioxyde de carbone Medical electrical equipment - Part 3-1 : Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment O CE1 1996 Droits de reproduction rservs -Copyright - all rights reserved Aucune partie de cette publicati

19、on ne peut tre reproduite ni No pari of this publication may be reproduced or utilized utilise sous quelque forme que ce soit et par aucun procd, in any form or by any means, electronic or mechanical. lectronique ou mcanique. y compris la photocopie et les including photocopying and microfilm. witho

20、ut microfilms. sans raccord crit de Iditeur. permission in writing from the publisher Bureau central de la Commission Electrotechnique Intemationale 3, rue de Varemb Genve, Suisse P Commission Electrotechnique Internationale CODE PRIX International Electrotechnical Commission PRICE COD E MeMyHapOnHa

21、FI JIKTPOTXHWCHR KOMICCLH Pourprix, voir catalogue en vigueur For price, see current catalogue w Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-2- SOMMAIRE 601-3-1 O CEI:1996

22、 AVANT-PROPOS INTRODUCTION . Articles 1 2 3 4 5 6 7 8 9 10 11 Domaine dapplication et objet Rfrences normatives . Dfinit ions Conditions dessais . DOCUMENTS DACCOMPAGNEMENT . Prcision TEMPS DE RPONSE . Enregistreur . SIGNAUX AVERTISSEURS . SOURCE LECTRIQUE INTERNE . TRANSDUCTEURS et cbles . Figures

23、1 2 Agencement dessai prconis pour lessai du TRANSDUCTEUR si le fabricant Cycle dessai pour lessai de linarit . Exemple de rsultats typiques ne recommande pas dautre chambre dessai Annexe A . Guide et justifications Pages 4 6 8 8 10 10 14 14 18 20 20 20 20 22 24 26 Copyright International Electrotec

24、hnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-601-3-1 O IEC:1996 -3- CONTENTS Page FOREWORD . 5 INTRODUCTION . 7 Clause 1 2 3 4 5 6 7 8 9 10 11 Scope and object Normative references . Definitions Test condit

25、ions . ACCOMPANYING DOCUMENTS . Accuracy RESPONSE TIME . Recorder WARNING SIGNALS INTERNAL ELECTRICAL POWER SOURCE . TRANSDUCERS and cables 9 9 11 11 15 15 19 21 21 21 21 Figures 1 2 Suggested test fixture for TRANSDUCER test. if the manufacturer does not recommend another test chamber . Test cycle

26、for linearity test . Example of typical results . 23 25 Annex A . Guidance and rationale . 27 Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-601-3-1 O CEI:1996 -4- FDIS 62D/1

27、89/FDIS COMMISSION LECTROTECHNIQUE INTERNATIONALE Rapport de vote 62D/209/RVD APPAREILS LECTROMDICAUX - Partie 3-1 : Prescriptions essentielles de performances pour les appareils de surveillance de la pression partielle transcutanee de loxygne et du dioxyde de carbone AVANT-PROPOS La CE1 (Commission

28、 Electrotechnique Internationale) est une organisation mondiale de normalisation compose de lensemble des comits lectrotechniques nationaux (Comits nationaux de la CEI). La CE1 a pour objet de favoriser la coopration internationale pour toutes les questions de normalisation dans les domaines de llec

29、tricit et de llectronique. A cet effet, la CEI, entre autres activits, publie des Normes Internationales. Leur laboration est confie des comits dtudes, aux travaux desquels tout Comit national intress par le sujet trait peut participer. Les organisations internationales, gouvernementales et non gouv

30、ernementales, en liaison avec la CEI, participent galement aux travaux. La CE1 collabore troitement avec lorganisation Internationale de Normalisation (ISO), selon des conditions fixes par accord entre les deux organisations. Les dcisions ou accords officiels de la CE1 concernant les questions techn

31、iques, reprsentent, dans la mesure du possible un accord international sur les sujets tudis, tant donn que les Comits nationaux intresss sont reprsents dans chaque comit dtudes. Les documents produits se prsentent sous la forme de recommandations internationales. Ils sont publis comme normes, rappor

32、ts techniques ou guides et agrs comme tels par les Comits nationaux. Dans le but dencourager lunification internationale, les Comits nationaux de la CE1 sengagent appliquer de faon transparente, dans toute la mesure possible, les Normes internationales de la CE1 dans leurs normes nationales et rgion

33、ales. Toute divergence entre la norme CE1 et la norme nationale ou rgionale correspondante doit tre indique en termes clairs dans cette dernire. La CE1 na fix aucune procdure concernant le marquage comme indication dapprobation et sa responsabilit nest pas engage quand un matriel est dclar conforme

34、lune de ses normes. Lattention est attire sur le fait que certains des lments de la prsente Norme internationale peuvent faire lobjet de droits de proprit intellectuelle ou de droits analogues. La CE1 ne saurait tre tenue pour responsable de ne pas avoir identifi de tels droits de proprit et de ne p

35、as avoir signal leur existence. Norme Internationale CE1 601-3-1 a t tablie Dar le sous-comit 62D: Appareils lectromdicaux, du comit dtudes 62 de la CEI: Equipements lectriques dans la piatique mdicale. Le texte de cette Norme Particulire est issu des documents suivants: Lannexe A est donne uniqueme

36、nt titre dinformation. Dans la prsente Norme Particulire, les caractres dimprimerie suivants sont utiliss: - prescriptions dont la conformit peut tre tablie et dfinitions: caractres romains; - notes, explications, conseils, introductions, noncs de porte gnrale, exceptions et rfrences: petits caractr

37、es romains; - spcifications dessai: caractres italiques; - TERMES EMPLOYES DANS CETTE NORME PARTICULIERE QUI SONT DEFINIS A LARTICLE 3 ET DANS LA CE1 601-1: PETITES CAPITALES. Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or n

38、etworking permitted without license from IHS-,-,-601-3-1 O IEC:1996 -5- INTERNATIONAL ELECTROTECHNICAL COMMISSION MEDICAL ELECTRICAL EQUIPMENT - Part 3-1 : Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment FOREWORD The IEC (Internat

39、ional Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote international co-operation on all questions concerning standardization in the electrical and electroni

40、c fields. To this end and in addition to other activities, the IEC publishes International Standards. Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-

41、governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. The formai decisions or agreements of

42、 the IEC on technical matters, express as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested National Committees. The documents produced have the form of recommendations for international use and ar

43、e published in the form of standards, technical reports or guides and they are accepted by the National Committees in that sense. In order to promote international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in thei

44、r national and regional standards. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter. The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be

45、in conformity with one of its standards. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 601 -3-1 has been p

46、repared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. The text of this Particular Standard is based on the following documents: I FDIS I Report on voting I Full information on the voting for the approval of this Particular Sta

47、ndard can be found in the report on voting indicated in the above table. Annex A is for information only. In this Particular Standard the following print types are used: - requirements, compliance with which can be tested, and definitions: in roman type; - notes, explanations, advice, introductions,

48、 general statements, exceptions and references: in smaller type; - test specifications: in italic type; - TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 3 AND IN IEC 601-1: SMALL CAPITALS Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-6- 601-3-1 O CEI:1996 I NTROD UCTIO N Les prsentes prescriptions de per