1、BSI Standards PublicationMedical electrical equipmentPart 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulatorsBS EN 60601-2-10:2015National forewordThis British Standard is the UK implementation of EN 60601-2-10:2015. It isidentical to IEC 6060
2、1-2-10:2012. It supersedes BS EN 60601-2-10:2001,which will be withdrawn on 22 May 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4, Electromedical equipment.A list of organizations represented on
3、 this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 69339 7IC
4、S 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601
5、-2-10:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-10 May 2015 ICS 11.040.60 Supersedes EN 60601-2-10:2000 English Version Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2
6、-10:2012) Appareils lectromdicaux - Partie 2-10: Exigences particulires pour la scurit de base et les performances essentielles des stimulateurs de nerfs et de muscles (IEC 60601-2-10:2012) Medizinische elektrische Gerte - Teil 2-10: Besondere Festlegungen fr die Sicherheit einschlielich der wesentl
7、ichen Leistungsmerkmale von Gerten zur Stimulation von Nerven und Muskeln (IEC 60601-2-10:2012) This European Standard was approved by CENELEC on 2012-07-09. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
8、 the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member. This European Standard exists in three official versions (Englis
9、h, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of A
10、ustria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, S
11、pain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights
12、of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-10:2015 E BS EN 60601-2-10:2015EN 60601-2-10:2015 (E) 2 Foreword The text of document 62D/1003/FDIS, future edition 2 of IEC 60601-2-10, prepared by IEC/SC 62 D “Electromedical equipment“ of IEC/
13、TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-10:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or
14、by endorsement (dop) 2015-11-22 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-05-22 This document supersedes EN 60601-2-10:2000. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent r
15、ights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For the
16、relationship with EU Directive see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-10:2012 was approved by CENELEC as a European Standard without any modification. BS EN 60601-2-10:2015EN 60601-2-10:2015 (E) 3 An
17、nex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited appli
18、es. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of th
19、e European Standards listed in this annex is available here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies with the following exceptions: Publication Year Title EN/HD Year Addition: IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential perf
20、ormance EN 60601-1 2006 +corrigendum Mar 2010 +AC 2014 +A11 2011 +A1 2012 +A1 2013 +A12 2014 Replacement: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requireme
21、nts and tests EN 60601-1-2 2007 +corrigendum Mar. 2010 BS EN 60601-2-10:2015EN 60601-2-10:2015 (E) 4 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free T
22、rade Association, and within its scope the Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this standard provides one means of conformity with the specified essential requirements of the Direct
23、ive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-2-10:2015 2 60601-2-10 IEC:2012 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references 7 2
24、01.3 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 EQUIPMENT identification, marking and documents . 9 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11 2
25、01.9 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 excessive temperatures and other HAZARDS . 11 201.12 Accuracy of controls and instruments and protection against hazardous
26、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 . 13 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 13 202 Electromagnetic compatibility Requi
27、rements 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 rationale 17 Index of defined terms used in this particular standard 20 Figure 202.101 Testing layout 15 Table 201.1
28、01 Pulse frequency versus applied current limits . 13 Table 201.C.101 Marking on the outside of STIMULATORS or their parts . 16 BS EN 60601-2-10:201560601-2-10 IEC:2012 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-10: Particular requirements for the basic safety
29、and essential performance of nerve and muscle stimulators FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-op
30、eration 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 Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to
31、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, governmental and non-governmental organizations liaising with the IEC also participate in this pr
32、eparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international co
33、nsensus 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 international use and are accepted by IEC National Committees in that sense. While all reasonable effort
34、s 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 to promote international uniformity, IEC National Committees undertake to apply IEC Publication
35、s 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 clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Indepe
36、ndent 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 bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No li
37、ability 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, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (in
38、cluding 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 this publication. Use of the referenced publications is indispensable for the correct application
39、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 or all such patent rights. International standard IEC 60601-2-10 has been prepared by IEC subcomm
40、ittee 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 1 (2001). This edition constitutes a technical revision and is aligned with IEC 60601-1:2005+A1
41、: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 standard can be found in the report on voting indicated in the above table. BS EN 60601-2-10:2015 4 606
42、01-2-10 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 type. Informative material appearing outside of tables, such as notes, exa
43、mples 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 structure of this standard, the term “clause” means one of the seventeen numbered
44、 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 Clause 7). References to clauses within this standard are preceded by the ter
45、m “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 combination of the conditions is true. The verbal forms used in this standard confo
46、rm 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 standard; “should” means that compliance with a requirement or a test is recomme
47、nded 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 of a paragraph or table title indicates that there is guidance or rationale
48、 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 this publication will remain unchanged until the stability date indicated on
49、 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. BS EN 60601-2-10:201560601-2-10 IEC:2012 5 INTRODUCTION 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 IE
