IEC 60601-2-62-2013 Medical electrical equipment - Part 2-62 particular requirements for the basic safety and essential performance of high intensity therapeuti.pdf

1、 IEC 60601-2-62 Edition 1.0 2013-07 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment Appareils lectromdicaux Partie 2-62: Exigences part

2、iculires pour la scurit de base et les performances essentielles des appareils ultrasonores thrapeutiques de haute intensit (HITU) IEC60601-2-62:2013 colourinsideTHIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2013 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part o

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16、us donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 60601-2-62 Edition 1.0 2013-07 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-62: Particular requirements for the basic safety and essential performance of h

17、igh intensity therapeutic ultrasound (HITU) equipment Appareils lectromdicaux Partie 2-62: Exigences particulires pour la scurit de base et les performances essentielles des appareils ultrasonores thrapeutiques de haute intensit (HITU) INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECH

18、NIQUE INTERNATIONALE XB ICS 11.040.01; 17.140.50 PRICE CODE CODE PRIX ISBN 978-2-8322-0865-6 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized di

19、stributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. colourinside 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 Terms and definitions 9 201.4 General r

20、equirements 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 Protection against mechanical hazards o

21、f 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 28 201.13 HAZARDOUS SITUATIONS and fault

22、 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 compatibility Requirements and tests . 30 Annexes

23、 . 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 in classification according to CISPR 11 .

24、 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 distance when applied to a PATIENT. IEC 6

25、1157 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 Illustration of target, intermediate (shaded or

26、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 TEMPORAL-AVERAGE INTENSITY (in dB) corre

27、cted for absorption vs transverse dimension in the focal plane 54 60601-2-62 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 geometric focal length of 40 mm at 1 MHz . 55 Figure DD.6 Overl

28、apping 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 Showing copper band in saline. 60 Table 201.101 List of symbols any

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36、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) Attention is drawn to the possibility that some of the elemen

37、ts 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 equipment Electromedical equipment, of IEC technical committee 62:

38、 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 information on the voting for the approval of this particula

39、r 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: 60601-2-62 IEC:2013 5 Requirements and definitions: roman type. Test specifications

40、 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 OR AS NOTED: SMALL CAPITALS. In referring to th

41、e 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 subclaus

42、es 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

43、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 requirement or a test is mandatory for compliance with th

44、is 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 be

45、ginning 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 series, published under the general title Medical electrical equipment, can be found on the IEC website. The committee has decided that the conte

46、nts of this 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. IMPORTANT The c

47、olour inside logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this document using a colour printer. 6 60601-2-62 IEC:2013 INTRODUCTION In this particular standar

48、d, safety requirements additional to those in the general standard are specified for HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT. This particular standard takes into account IEC 62555 and IEC/TS 62556. The requirements are followed by specifications for the relevant tests. A rationale for

49、 the more important requirements, where appropriate, is given in Annex AA. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the particular 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