EN 60601-2-62-2015 en Medical electrical equipment - Part 2-62 Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipmentBS EN 60601-2-62:2015National forewordThis British Standard is the UK implementation of EN 60601-2-62:2015.

2、It isidentical to IEC 60601-2-62:2013.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 this committee can be obtained onrequest to its s

3、ecretary.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 65039 0ICS 11.040.01; 17.140.50Compliance with a British St

4、andard 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 60601-2-62:2015EUROPEAN STANDARDNORME EUROPE

5、NNEEUROPISCHE NORMEN 60601-2-62 May 2015 ICS 11.040.01; 17.140.50 English Version Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensitytherapeutic ultrasound (HITU) equipment (IEC 60601-2-62:2013) Appareils lectromdicaux -

6、Partie 2-62: Exigencesparticulires pour la scurit de base et les performancesessentielles des appareils ultrasonores thrapeutiques dehaute intensit (HITU) (IEC 60601-2-62:2013) Medizinische elektrische Gerte - Teil 2-62: BesondereAnforderungen an die Sicherheit einschlielich derwesentlichen Leistung

7、smerkmale von hochintensiven therapeutischen Ultraschallsystemen (HITU-Systemen) (IEC 60601-2-62:2013) This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European S

8、tandard 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 (

9、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 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, Sloven

11、ia, Spain, Sweden, Switzerland,Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All righ

12、ts of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-62:2015 E EN 60601-2-62:2015 2 Foreword The text of document 62D/1069/FDIS, future IEC 60601-2-62, prepared by SC 62D “Electromedical equipment“ of IEC/TC 62 “Electrical equipment in medical p

13、ractice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-62:2015. 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 endorsement (dop) 2016-01-14 latest d

14、ate 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 rights. CENELEC and/or CEN shall not be held responsible for identifying any or all su

15、ch 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. For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral

16、 part of this document. Endorsement notice The text of the International Standard IEC 60601-2-62:2013 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-2-5 NO

17、TE Harmonized as EN 60601-2-5. IEC 60601-2-36 NOTE Harmonized as EN 60601-2-36. IEC 60529 NOTE Harmonized as EN 60529. IEC 61161 NOTE Harmonized as EN 61161. IEC 61828 NOTE Harmonized as EN 61828. IEC 62464-1 NOTE Harmonized as EN 62464-1. IEC 62555 NOTE Harmonized as EN 62555. BS EN 60601-2-62:2015

18、EN 60601-2-62:2015 3 Annex 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

19、the edition cited applies. 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 th

20、e latest versions of the European Standards listed in this annex is available here: www.cenelec.eu Annex ZA of EN 60601-1:2006 applies except as follows: Publication Year Title EN/HD Year Replacement: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic sa

21、fety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 1)2010 1)Addition: IEC 61689 2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz

22、 EN 61689 2013 IEC/TS 61949 - Ultrasonics - Field characterization - In situ exposure estimation in finite-amplitude ultrasonic beams CLC/TS 61949 - IEC 62127-1 - Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz EN 62127-1 - IEC 62127-2 -

23、 Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields up to 40 MHz EN 62127-2 - IEC 62359 - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields EN 62359 - IEC 62555 - Ultrasonics

24、- Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems EN 62555 - IEC/TS 62556 - Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems - - 1)Superseded by E

25、N 60601-1-2:2014 (IEC 60601-1-2:2014): DOW = 2018-12-31. BS EN 60601-2-62:2015EN 60601-2-62:2015 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 Tra

26、de 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 Directiv

27、e concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-2-62:2015 2 60601-2-62 IEC:2013 CONTENTS FOREWORD . 4 INTRODUCTION . 6 201.1 Scope, object and related standards 7 201.2 Normative references 9 201.3

28、 Terms and definitions 9 201.4 General requirements 21 201.5 General requirements for testing of ME EQUIPMENT . 22 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 23 201.7 ME EQUIPMENT identification, marking and documents 23 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 25 201.9

29、 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 25 201.10 Protection against unwanted and excessive radiation HAZARDS 25 201.11 Protection against excessive temperatures and other HAZARDS 28 201.12 Accuracy of controls and instruments and protection against hazardous outputs

30、28 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 30 201.14 Programmable ELECTRICAL MEDICAL SYSTEMS (PEMS). 30 201.15 Construction of ME EQUIPMENT . 30 201.16 ME systems . 30 201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 30 202 Electromagnetic compatibi

31、lity Requirements and tests . 30 Annexes . 33 Annex AA (informative) Particular guidance and rationale 34 Annex BB (informative) Targeting 38 Annex CC (informative) HITU specific risks . 41 Annex DD (informative) Determining regions of HITU fields for measurement 46 Annex EE (informative) Guidance i

32、n classification according to CISPR 11 . 57 Annex FF (informative) Notes on using a saline or water bath for EMI testing 58 Bibliography 61 Figure 201.101 Schematic diagram showing the relationship between the various defined surfaces and distances for an ULTRASONIC TRANSDUCER with water stand-off d

33、istance when applied to a PATIENT. IEC 61157 Ed2 . 20 Figure 201.102 Parameters for describing a focusing transducer of a known geometry 20 Figure 201.103 Example set-up for the measurement of the unwanted ultrasound radiation on the side-wall (the handle) of the transducer . 27 Figure DD.1 Illustra

34、tion of target, intermediate (shaded or yellow) region and safe regions defined by boundaries 1 and 2. 46 Figure DD.2 Exposure time vs temperature increase above 37 C for three different bioffects threshold exposures shown as solid curves. 47 Figure DD.3 Two-layer model with target . 51 Figure DD.4

35、TEMPORAL-AVERAGE INTENSITY (in dB) corrected for absorption vs transverse dimension in the focal plane 54 BS EN 60601-2-62:201560601-2-62 IEC:2013 3 Figure DD.5 TEMPORAL-AVERAGE INTENSITY (in dB) vs axial distance z (mm) for a beam from a spherical focusing transducer with a radius of 20 mm and a ge

36、ometric focal length of 40 mm at 1 MHz . 55 Figure DD.6 Overlapping multiple exposure regions in a target region depicted by the dark ellipse . 56 Figure FF.1 Representing the patient or operator impedance. 58 Figure FF.2 Possible setup for artificial hand for HITU equipment. . 59 Figure FF.3 Showin

37、g copper band in saline. 60 Table 201.101 List of symbols 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 collabora

38、tes 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 consensus of opinion on th

39、e 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 efforts are made to ensure tha

40、t 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 OPERATOR. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the m

41、aximum 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. Independent certification bodi

42、es 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 liability shall attach to

43、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 (including legal fees) and

44、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 of this publication. 9)

45、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 60601-2-62 has been prepared by IEC subcommittee 62D: Therapy equip

46、ment Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. It has been prepared in close co-operation with TC 87 (Ultrasonics). The text of this particular standard is based on the following documents: FDIS Report on voting 62D/1069/FDIS 62D/1076/RVD Full

47、 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 used: BS EN 60601-2-62:20156

48、0601-2-62 IEC:2013 5 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 STA

49、NDARD, 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 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 term “Clause” followed by th