IEC 60601-2-10-2012 Medical electrical equipment - Part.2-10 Particular requirements for the basic safety and essential performance of nerve and muscle stimulat.pdf

1、 IEC 60601-2-10 Edition 2.0 2012-06 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators Appareils lectromdicaux Partie 2-10: Exigences particulires pour la scurit de

2、 base et les performances essentielles des stimulateurs de nerfs et de muscles IEC60601-2-10:2012 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or

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16、 des questions contactez-nous: csciec.ch. IEC 60601-2-10 Edition 2.0 2012-06 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators Appareils lectromdicaux Partie 2-10:

17、 Exigences particulires pour la scurit de base et les performances essentielles des stimulateurs de nerfs et de muscles INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE S ICS 11.040.60 PRICE CODE CODE PRIX ISBN 978-2-83220-193-0 Registered trademark of the Interna

18、tional Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 60601-2-10 IEC:201

19、2 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references 7 201.3 Terms and definitions 8 201.4 General requirements . 8 201.5 General requirements for testing of ME EQUIPMENT 9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 9 201.7 ME EQU

20、IPMENT identification, marking and documents . 9 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 11 201.10 Protection against unwanted and excessive radiation HAZARDS . 11 201.11 Protection against excess

21、ive temperatures and other HAZARDS . 11 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 11 201.13 HAZARDOUS SITUATIONS and fault conditions 13 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 13 201.15 Construction of ME EQUIPMENT . 13 201.16 ME SYSTEMS

22、. 13 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 13 202 Electromagnetic compatibility Requirements and tests . 14 Annexes . 15 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 16 Annex AA (informative) Particular guidance and

23、 rationale 17 Index of defined terms used in this particular standard 20 Figure 202.101 Testing layout 15 Table 201.101 Pulse frequency versus applied current limits . 13 Table 201.C.101 Marking on the outside of STIMULATORS or their parts . 16 60601-2-10 IEC:2012 3 INTERNATIONAL ELECTROTECHNICAL CO

24、MMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotec

25、hnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specification

26、s, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, g

27、overnmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisio

28、ns or agreements of 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 IEC National Committees. 3) IEC Publications have the form of recommendations for internat

29、ional use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order

30、 to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clear

31、ly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bo

32、dies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, proper

33、ty damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in th

34、is publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any o

35、r all such patent rights. International standard IEC 60601-2-10 has been prepared by IEC subcommittee 62D: Electromedical equipment of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition, published in 1987 and its Amendment

36、 1 (2001). This edition constitutes a technical revision and is aligned with IEC 60601-1:2005+A1:2012. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/1003/FDIS 62D/1015/RVD Full information on the voting for the approval of this particular standar

37、d can be found in the report on voting indicated in the above table. 4 60601-2-10 IEC:2012 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic

38、type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structu

39、re of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Cla

40、use 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combinati

41、on of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standa

42、rd; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning o

43、f a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. The committee has decided that the contents of th

44、is publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 60601-2-10 IEC:2012 5 IN

45、TRODUCTION The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of nerve and muscle stimulators. This particular standard amends and supplements IEC 60601-1 (third edition, 2005 plus Amendment 1, 2012): Medi

46、cal electrical equipment Part 1: General requirements for safety and essential performance hereinafter referred to as the General Standard (see 201.1.4). The requirements are followed by specifications for the relevant tests. A “Particular guidance and rationale“ section giving some explanatory note

47、s, where appropriate, about the more important requirements is included in Annex AA. Clauses or subclauses for which there are explanatory notes in Annex AA are marked with an asterisk (*). It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper ap

48、plication of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this standard. 6 60601-2-10 IEC:2012 MEDICAL ELECTRICAL EQUIPMENT Part 2-1

49、0: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators 201.1 Scope, object and related standards Clause 1 of the general standard1)applies, except as follows: 201.1.1 * Scope Replacement: This International Standard specifies the requirements for the safety of nerve and muscle STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine, herei