EN 60601-2-6-2015 en Medical electrical equipment - Part 2-6 Particular requirements for the basic safety and essential performance of microwave therapy equipment (Incorporates Ame.pdf

1、Medical electrical equipmentPart 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipmentBS EN 60601-2-6:2015+A1:2016(IEC 60601-2-6:2012)BSI Standards PublicationBS EN 60601-2-6:2015+A1:2016 BRITISH STANDARDNational forewordThis British Standard is t

2、he UK implementation of EN 60601-2-6:2015+A1:2016. It is identical to IEC 60601-2-6:2012, incorporating amendment 1:2016. It supersedes BS EN 60601-2-6:2015 which will be withdrawn on 30 September 2019.The start and finish of text introduced or altered by amendment is indicated in the text by tags.

3、Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by g1g2.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4, Electrom

4、edical equipment.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Pu

5、blished by BSI Standards Limited 2016ISBN 978 0 580 90073 0ICS 11.040.60Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued

6、 since publicationDate Text affected31 October 2016 Implementation of IEC amendment 1:2016 with CENELEC endorsement A1:2016EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-6 May 2015 ICS 11.040.60 English Version Medical electrical equipment - Part 2-6: Particular requirements for the ba

7、sic safety and essential performance of microwave therapy equipment (IEC 60601-2-6:2012) Appareils lectromdicaux - Partie 2-6: Exigences particulires pour la scurit de base et les performances essentielles des appareils de thrapie micro-ondes (IEC 60601-2-6:2012) Medizinische elektrische Gerte - Tei

8、l 2-6: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Mikrowellen-Therapiegerten (IEC 60601-2-6:2012) This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipu

9、late the conditions for giving this European Standard 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 Europe

10、an Standard exists in three official versions (English, 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 memb

11、ers are the national electrotechnical committees of Austria, 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, Nor

12、way, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, 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: Avenu

13、e Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-6:2015 E EN 60601-2-6:2015+A1September 2016Foreword The text of document 62D/985/FDIS, future edition 2 of IEC 60601-2-6, prepared by SC 62D,

14、“Electromedical equipment“, of IEC TC 62, “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-6:2015. The following dates are fixed: g120 latest date by which the document has to be implemented at national level by publicati

15、on of an identical national standard or by endorsement (dop) 2016-01-14 g120 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent r

16、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

17、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 60601-2-6:2012 was approved by CENELEC as a European Standard without any modification. 2 BS EN 60601-2-6:2015+A1:2016EN 60601-2-6:2015+A

18、1:2016 (E) 3 BS EN 60601-2-6:2015+A1:2016EN 60601-2-6:2015+A1:2016 (E)The text of document 62D/1331/FDIS, future IEC 60601-2-6:2012/A1, prepared by SC 62D “Electromedical equipment“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved b

19、y CENELEC as EN 60601-2-6:2015/A1:2016. The following dates are fixed: g120 latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2017-03-30 g120 latest date by which the national standards conflicting with

20、the document have to be withdrawn (dow) 2019-09-30 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared und

21、er 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 relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-6:2015. Endorsement notice The text of the Inte

22、rnational Standard IEC 60601-2-6:2012/A1:2016 was approved by CENELEC as a European Standard without any modification. Foreword to amendment A1EN 60601-2-6:2015 (E) Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate giv

23、en to CENELEC by the European Commission and the European Free Trade 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 co

24、nformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-2-6:2015 4 BS EN 60601-2-6:2015+A1:2016EN 60601-2-6:2015+A1:2016 (E) 2 60601-2-6 IE

25、C:2012 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references 7 201.3 Terms and definitions 7 201.4 General requirements 8 201.5 General requirements for testing of ME EQUIPMENT . 8 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 9 201.7 M

26、E EQUIPMENT 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 excessive

27、 temperatures and other HAZARDS 12 201.12 Accuracy of controls and instruments and protection against hazardous outputs 12 201.13 HAZARDOUS SITUATIONS and fault conditions . 14 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 14 201.15 Construction of ME EQUIPMENT . 14 201.16 ME SYSTEMS 14 20

28、1.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 14 202 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 ration

29、ale 17 Index of defined terms used in this particular standard 20 Table 201.101 Additional ESSENTIAL PERFORMANCE requirements 8 Table 201.C.101 Marking on the outside of MICROWAVE THERAPY EQUIPMENT or its parts . 16 Table 201.C.102 Marking on the inside of MICROWAVE THERAPY EQUIPMENT or its parts .

30、16 BS EN 60601-2-6:2015BS EN 60601-2-6:2015+A1:2016IEC 60601-2-6:2012+A1:2016 5 g1HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENTg2g1Electromagnetic disturbances requirements and testsg2689101011111212141414151517171717171718192023111919The text of this particular standard is based on the

31、 following documents: FDIS Report on voting 62D/985/FDIS 62D/1008/RVDFull information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. 60601-2-6 IEC:2012 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUI

32、PMENT Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Comm

33、ittees). 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 Specifications, Technical Reports, Publicly Avail

34、able 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, governmental and non-governmental org

35、anizations 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 decisions or agreements of IEC on technical

36、 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 international use and are accepted by IEC Na

37、tional 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 to promote international uniformity

38、, 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 clearly indicated in the latter. 5) IEC i

39、tself 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 bodies. 6) All users should ensure tha

40、t 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, property damage or other damage of any nat

41、ure 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 this publication. Use of the reference

42、d 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 or all such patent rights. Internatio

43、nal standard IEC 60601-2-6 has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. BS EN 60601-2-6:2015BS EN 60601-2-6:2015+A1:2016IEC 60601-2-6:2012+A1:2016 6 This second edition cancels and replaces the first edition

44、 of IEC 60601-2-6, published in 1984. This edition constitutes a technical revision and has been aligned with g1IEC 60601-1g2. 4 60601-2-6 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

45、and definitions: roman type. Test specifications: italic 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

46、 OR AS NOTED: SMALL CAPITALS. In referring to the structure 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

47、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 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

48、an “inclusive or” so a statement is true if any combination 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 requireme

49、nt or a test is mandatory for compliance with this standard; “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 of 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 ser