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
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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
7、es. CSA standards reflect a national consensus of producers and users - including manufacturers, consumers, retailers, unions and professional organizations, and governmental agencies. The standards are used widely by industry and commerce and often adopted by municipal, provincial, and federal gove
8、rnments in their regulations, particularly in the fields of health, safety, building and construction, and the environment. Individuals, companies, and associations across Canada indicate their support for CSAs standards development by volunteering their time and skills to CSA Committee work and sup
9、porting the Associations objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships together form CSAs total membership from which its Directors are chosen. Sustaining memberships represent a major source of income for CSAs standards develo
10、pment activities. The Association offers certification and testing services in support of and as an extension to its standards development activities. To ensure the integrity of its certification process, the Association regularly and continually audits and inspects products that bear the CSA Mark.
11、In addition to its head office and laboratory complex in Toronto, CSA has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Since 1919, the Association has developed the necessary expertise to meet its corporate mission: CSA is an independ
12、ent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards, certification and related services to meet national and international needs. For further information on CSA services, write to
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
16、f capable individuals whose collective interests provide to the greatest practicable extent a balance of representation of producers, users, consumers, and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard which is capable of making a significant
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
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