BS EN 60601-2-5-2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment《医疗用电气设备 超声波物理治疗设备基本安全.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipmentBS EN 60601-2-5:2015National forewordThis British Standard is the UK implementation of EN 60601-2-5:2015. It is identical to IEC

2、60601-2-5:2009. It supersedes BS EN 60601-2-5:2001, which will be withdrawn on 15 September 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice,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 repre

3、sented on 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

4、60881 0ICS 11.040.60 Compliance 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 November 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STAND

5、ARDBS EN 60601-2-5:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-5 October 2015 ICS 11.040.60 Supersedes EN 60601-2-5:2000 English Version Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy eq

6、uipment (IEC 60601-2-5:2009) Appareils lectromdicaux - Partie 2-5: Exigences particulires pour la scurit de base et les perfomances essentielles des appareils ultrasons pour physiothrapie (IEC 60601-2-5:2009) Medizinische elektrische Gerte - Teil 2-5: Besondere Festlegungen fr die Sicherheit einschl

7、ielich der wesentlichen Leistungsmerkmale von Ultraschall-Physiotherapiegerten (IEC 60601-2-5:2009) This European Standard was approved by CENELEC on 2015-09-15. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Stan

8、dard 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 (En

9、glish, 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

10、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, Norway, Poland, Portugal, Romania, Slovakia, Sloveni

11、a, 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: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rig

12、hts of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-5:2015 E BS EN 60601-2-5:2015EN 60601-2-5:2015 2 European foreword The text of document 62D/693/CDV, future edition 3 of IEC 60601-2-5, prepared by SC 62D “Electromedical equipment“, of IEC/T

13、C 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-5:2015. 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 by

14、 endorsement (dop) 2016-06-15 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-09-15 This document supersedes EN 60601-2-5:2000. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent righ

15、ts. 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 rel

16、ationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-5:2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography

17、, the following notes have to be added for the standards indicated: IEC 60601-2-36:1997 NOTE Harmonized as EN 60601-2-36:1997 (not modified). IEC 61161:2006 NOTE Harmonized as EN 61161:2007 (not modified). BS EN 60601-2-5:2015EN 60601-2-5:2015 3 Annex ZA (normative) Normative references to internati

18、onal 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 applies. For undated references, the latest edition of th

19、e 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 the European Standards listed in this annex is availab

20、le here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replacement in Annex ZA of EN 60601-1:2006: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collatera

21、l standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 - - + corrigendum Mar. 2010 Addition to Annex ZA of EN 60601-1:2006: IEC 61689 2007 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz EN 61

22、689 2007 IEC 62127-1 2007 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz EN 62127-1 2007 IEC 62127-2 2007 Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields up to 40 MHz EN 62127-2 2007 BS EN 60601-2-5:2015EN 60601-2-

23、5:2015 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 Trade Association, and within its scope the Standard covers all relevant essential requiremen

24、ts 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 Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the pro

25、ducts falling within the scope of this standard. BS EN 60601-2-5:2015 2 60601-2-5 IEC:2009 CONTENTS FOREWORD.0H3 INTRODUCTION.1H6 201.1 Scope, object and related standards .2H7 201.2 Normative references 3H9 201.3 Terms and definitions4H9 201.4 General requirements 5H12 201.5 General requirements fo

26、r testing of ME EQUIPMENT. 6H13 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 7H13 201.7 *ME EQUIPMENT identification, marking and documents 8H13 201.8 *Protection against electrical HAZARDS from ME EQUIPMENT 9H14 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 10H15

27、 201.10 Protection against unwanted and excessive radiation HAZARDS 11H15 201.11 Protection against excessive temperatures and other HAZARDS 12H16 201.12 Accuracy of controls and instruments and protection against hazardous outputs13H19 201.13 HAZARDOUS SITUATIONS and fault conditions. 14H21 201.14

28、PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15H21 201.15 Construction of ME EQUIPMENT . 16H21 201.16 ME SYSTEMS 17H22 201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 18H22 202 Electromagnetic compatibility Requirements and tests . 19H22 Annexes . 20H23 Annex AA (informative

29、) Particular guidance and rationale 21H24 Annex BB (informative) Example set-up to measure surface temperature of externally applied TRANSDUCER ASSEMBLIES . 22H29 Bibliography 23H32 Index of defined terms used in this particular standard 24H33 Figure BB.1 Set-up of an example test object to measure

30、the surface temperature of externally applied transducers 25H31 Table 201.101 List of symbols 26H12 Table 201.102 Distributed ESSENTIAL PERFORMANCE requirements 27H13 Table 201.103 Overview of the tests noted under 201.11.1.3 . 28H19 Table BB.1 Acoustic and thermal properties of tissues and material

31、s . 29H29 Table BB.2 Weight % pure components . 30H30 BS EN 60601-2-5:201560601-2-5 IEC:2009 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment FOREWORD 1) T

32、he 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-operation on all questions concerning standardization in the electrical a

33、nd 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 as “IEC Publication(s)”). Their preparation is entrusted to technical c

34、ommittees; 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 preparation. IEC collaborates closely with the International Organization

35、 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 consensus of opinion on the relevant subjects since each technical commit

36、tee 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 efforts are made to ensure that the technical content of IEC Publications is

37、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 Publications transparently to the maximum extent possible in their national and re

38、gional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in confor

39、mity with an IEC Publication. 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

40、 personal injury, property 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 Normativ

41、e references cited in this 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 responsib

42、le for identifying any or all such patent rights. International standard IEC 60601-2-5 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This thirdedition cancels and replaces the second edition published in

43、2000. This edition constitutes a technical revision. The numbering was revised to agree with IEC 60601-1:2005 (third edition). Beyond this, essential performance characteristics are defined in 201.4.3.101, guidance on maintenance is added in 201.7.9.2.1, a new requirement regarding dielectric withst

44、and was added in 201.8.8.3. The clause on transducer surface temperature rise, 201.11, has been modified to allow for simulated use conditions. Measurements of ultrasound-related parameters are now referenced to IEC 61689:2007 (second edition). The most important change in the ultrasound-related par

45、ameters is the definition of EFFECTIVE RADIATING AREA, 201.3.207. This change will also affect the value of the EFFECTIVE INTENSITY and its uncertainty. BS EN 60601-2-5:2015 4 60601-2-5 IEC:2009 The text of this particular standard is based on the following documents: Enquiry draft Report on voting

46、62D/693/CDV 62D/766/RVC 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. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are

47、used: Requirements 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

48、PARTICULAR STANDARD 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 numbere

49、d 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 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 combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Direc