CAN CSA-C22 2 NO 60601-2-40-2001 Medical electrical equipment - Part 2-40 Particular requirements for the safety of electromyographs and evoked response equipment (First Edition).pdf

1、i * National Standard of Canada al- _. -NADIAN STAiDARDS CAN/CSA-C22.2 No. 60601-2-40-01 m ASSOCIATION CANADIENNE ASSOCIATION (CEI/IEC 60601-2-40:1998) DE NORMALISATION - Norme nationale du Canada - - International Standard CEI/IEC 60601-2-40: 1998 (first edition, 1998-02) has been adopted without m

2、odification as CSA Standard CANKSA-C22.2 No. 60601-2-40-01, which has been approved as a National Standard of Canada by the Standards Council of Canada. ISBN l-55324-472-9 June 2001 Lanormeinternationale CEI/IEC60601-2-40: 1998(premi cet aspect demeure la responsabilit de lorganisme rdacteur.de norm

3、es accrdit. II est recommand aux personnes qui ont besoin de normes de se servir des Normes nationales du Canada lorsque la chose est possible. Ces normes font lobjet dexamens priodiques ; cest pourquoi il est recommand aux utilisateurs de se procurer ldition la plus rcente de la norme auprs de lorg

4、anisme qui la prpare. La responsabilit dapprouver les Normes nationales du Canada incombe au Conseil canadien des normes 270, rue Albert, Bureau 200 Ottawa (Ontario) Kl P 6N7 Canada ASSOCIATION CAiAOIENNE DE NORMALISATION / . National Standards of Canada are published in English and French. Bien que

5、 le but premier vis par cette norme soit nonc sous sa rubrique Domaine dapplication, il est important de reteniLqui/ incombe lutilisateur de juger si la norme convient ses besoins particuliers. Marque dpose de lAssociation canadienne de normalisation The Canadian Standards Association (CSA), under w

6、hose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged in standards development and certification activiti

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13、 Canadian Standards Association 178 Rexdale Boulevard Toronto, Ontario, M9W 1 R3 Canada CANADIAN STANDARDS ASSOCIATION The Standards Council of Canada is the coordinating body of the National Standards system, a federation of independent, autonomous organizations working towards the further developm

14、ent and improvement of voluntary standardization in the national interest. The principal objects of the Council are to foster and promote voluntary standardization as a means of advancing the national economy, benefiting the health, safety, and welfare of the public, assisting and protecting the con

15、sumer, facilitating domestic and international trade, and furthering international cooperation in the field of standards. A National Standard of Canada is a standard which has been approved by the Standards Council of Canada and one which reflects a reasonable agreement among the views of a number o

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17、 and timely contribution to the national interest. Approval of a standard as a National Standard of Canada indicates that a standard conforms to the criteria and procedures established by the Standards Council of Canada. Approval does not refer to the technical content of the standard; this remains

18、the continuing responsibility of the accredited standards-development organization. Those who have a need to apply standards are encouraged to use National Standards of Canada whenever practicable. These standards are subject to periodic review; therefore, users are cautioned to obtain the latest ed

19、ition from the organization preparing the standard. The responsibility for approving National Standards of Canada rests with the Standards Council of Canada 270 Albert Street, Suite 200 Ottawa, Ontario, Kl P 6N7 Canada Les normes nationales du Canada sont publiees en versions francaise et anglaise.

20、Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users to judge its suitability for their particular purpose. Registered trade-mark of Canadian Standards Association CANKSA-C22.2 no 60601-2-40-07 Appa

21、reils lectromdicaux - Partie 2-40 : Rgles particulires de scurit pour les lectromyographes et les appareils potentiel voqu CAN/CSA-C22.2 no 60601-2-40-01 AppareiZs lectromdicaux - Pu ESSAIS DENVIRONNEMENT 24 26 SECTION DIX: RGLES DE CONSTRUCTION Figure 101 . . . . . . . . . . . . . . . . . . . . . .

22、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Annexes 28 L - Rfrences - Publications mentionnes dans la prsente Norme ._. 30 AA (informative) - Guide g

23、nral et justifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . _ 32 Pages - . 60601-2-40 0 IEC:1996 -5- Pages SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data . . . . . . . . . . . . . . . . . . .

24、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . _._. 25 51 Protection against hazardous output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . _._._. 27 SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN: C

25、ONSTRUCTIONAL REQUIREMENTS Figure 101 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Annexes L - Reference

26、s - Publications mentioned in this Standard . . . . . . . . . . . . . . . . . . . . . . . . _. 31 AA (informative) - General guidance and rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 -6- 60601 -2-40 0 CEI:1996 CMMI

27、IN LECTROTECHNIOUE INTERNATIONALE - APPAREIL LECTROMDICAUX - Partie 2-40: Rgles particulires de scurit pour les lectromyographes et les appareils potentiel voqu AVANT-PROPOS 1) La CEI (Commission Electrotechnique Internationale) est une organisation mondiale de normalisation compose de lensemble des

28、 comits lectrotechniques nationaux (Comits nationaux de la CEI). La CEI a pour objet de favoriser la coopration internationale pour toutes les questions de normalisation dans les domames de llectricit et de llectronique. A cet effet, la CEI, entre autres activits, publie des Normes internationales.

29、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 gouvernementales, en liaison avec la CEI, participent galement aux travaux. La CEI collabore troitement avec l

30、Organisation Internationale de Normalisation (ISO), selon des conditions fixes par accord entre les deux organisations. 2) Les dcisions ou accords officiels de la CEI concernant les questions techniques reprsentent, dans la mesure du possible un accord international sur les sujets tudis, tant donn q

31、ue les Comits nationaux intresss sont reprsents dans chaque comit dtudes. 3) Les documents produits se prsentent sous la forme de recommandations internationales. Ils sont publis comme normes, rapports techniques ou guides et agrs comme tels par les Comits nationaux. 4) Dans le but dencourager lunif

32、ication internationale, les Comits nationaux de la CEI sengagent appliquer de faon transparente, dans toute la mesure possible, les Normes internationales de la CEI dans leurs normes nationales et rgionales. Toute divergence entre la norme de la CEI et la norme nationale ou rgionale correspondante d

33、oit tre indique en termes clairs dans cette dernire. 5) La CEI na fix aucune procdure concernant le marquage comme indication dapprobation et sa responsabilit nest pas engage quand un matriel est dclar conforme lune de ses normes. 6) Lattention est attire sur le fait que certains des lments de la pr

34、sente Norme internationale peuvent faire lobjet de droits de proprit intellectuelle ou de droits analogues. La CEI ne saurait tre tenue pour responsable de ne pas avoir identifi de tels droits de proprit et de ne pas avoir signale leur existence. La Norme internationale CEI 60601-2-40 a t tablie par

35、 le sous-comit 62D: Appareils lectromdicaux, du comit dtudes 62 de la CEI: Equipements lectriques dans la pratique mdicale. Le texte de cette norme est issu des documents suivants: I FDIS I Rapport de vote I 62DI255IFDIS 62D1272lRVD Le rapport de vote indiqu dans le tableau ci-dessus donne toute inf

36、ormation sur le vote ayant abouti lapprobation de cette norme. Lannexe AA est donne uniquement titre dinformation. Dans la prsente Norme Particulire, les caractres dimprimerie suivants sont utiliss: - prescriptions dont la conformit peut tre vrifie par un essai et dfinitions: caractres romains; - no

37、tes, explications, conseils, introductions, noncs de porte gnrale, exceptions et rfrences: petits caractres romains; - spcifications dessai: caractres italiques; - TERMES EMPLOYS DANS CETTE NORME PARTICULIRE QUI SONT DFINIS A LARTICLE 2 ET DANS LA CEI 60601-I : PETITES CAPITALES. 60601-2-40 0 IEC:19

38、98 -7- INTERNATIONAL ELECTROTECHNICAL COMMISSION MEDICAL ELECTRICAL EQUIPMENT - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment FOREWORD 1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprisi

39、ng 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 electronic fields. To this end and in addition to other activities, the IEC publishes Internabonal S

40、tandards. 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-governmental organizations liaismg with the IEC also participate in this preparation. The IE

41、C collaborates closely with the lnternatronal Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an international consensus o

42、f opinion on the relevant subjects since each technical committee has representatron from all interested National Committees. 3) The documents produced have the form of recommendations for international use and are published in the form of standards, technical reports or guides and they are accepted

43、 by the National Committees in that sense. 4) In order to promote international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IEC Standard and the c

44、orresponding national or regional standard shall be clearly indicated in the latter. 5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its standards. 6) Attention is drawn to the possibility

45、 that some of the elements of this International Standard may be the subject of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 60601-2-40 has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical

46、committee 62: Electrical equipment in medical practice. The text of this standard is based on the following documents: FDIS Report on voting 62D1255/FDIS 62Dl272IRVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. An

47、nex AA 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, general statements, exceptions and references: in smaller roman type; - t

48、est specifications: in italic type; - TERMS USED THROUGHOUT THE PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 2 AND IN IEC 60601-l : SMALL CAPITALS. -8- 60601 -2-40 0 CEI:1998 INTRODUCTION La prsente Norme Particulire modifie et complte la CEI 60601-l (deuxime dition, 1988): Appareils lectro

49、mdicaux - Partie 1: Rgles gnrales de scurit, telle que modifie par son amendement 1 (1991) et par son amendement 2 (1995), appele Norme Gnrale dans la prsente Norme Particulire (voir 1.3). Les prescriptions sont suivies de spcifications relatives aux essais correspondants. Conformment la dcision prise par le sous-comit 62D lors de sa runion tenue Washington e