1、 IEC 62359Edition 2.0 2010-10INTERNATIONAL STANDARD NORME INTERNATIONALEUltrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields Ultrasons Caractrisation du champ Mthodes dessai pour la dtermination dindic
2、es thermique et mcanique des champs dultrasons utiliss pour le diagnostic mdical IEC62359:2010 colourinsideTHIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2010 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any
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16、donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du Service clients ou contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 62359Edition 2.0 2010-10INTERNATIONAL STANDARD NORME INTERNATIONALEUltrasonics Field characterization Tes
17、t methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields Ultrasons Caractrisation du champ Mthodes dessai pour la dtermination dindices thermique et mcanique des champs dultrasons utiliss pour le diagnostic mdical INTERNATIONAL ELECTROTECHNICA
18、L COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XBICS 17.140.50 PRICE CODECODE PRIXISBN 978-2-88912-181-6 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale colourinside 2 62359 IEC:2010 CONTENTS FOREWORD.4 INTR
19、ODUCTION.6 1 Scope.7 2 Normative references .7 3 Terms and definitions .8 4 List of symbols .21 5 Test methods for determining the mechanical index and the thermal index .23 5.1 General .23 5.2 Determination of mechanical index23 5.2.1 Determination of attenuated peak-rarefactional acoustic pressure
20、 .23 5.2.2 Calculation of mechanical index 23 5.3 Determination of thermal index general 24 5.4 Determination of thermal index in non-scanning mode.24 5.4.1 Determination of soft tissue thermal index for non-scanning modes .24 5.4.2 Determination of bone thermal index, TIB, for non-scanning modes.25
21、 5.5 Determination of thermal index in scanning modes26 5.5.1 Determination of soft tissue thermal index for scanning modes26 5.5.2 Determination of bone thermal index for scanning modes 27 5.6 Calculations for combined-operating mode 28 5.6.1 Acoustic working frequency .28 5.6.2 Thermal index28 5.6
22、.3 Mechanical index.29 5.7 Summary of measured quantities for index determination29 Annex A (informative) Rationale and derivation of index models .30 Annex B (informative) Guidance notes for measurement of output power in combined modes, scanning modes and in 1 cm 1 cm windows.51 Annex C (informati
23、ve) The contribution of transducer self-heating to the temperature rise occurring during ultrasound exposure.58 Annex D (informative) Guidance on the interpretation of TI and MI 59 Annex E (informative) Differences from IEC 62359 Edition 161 Bibliography64 Figure 1 Schematic diagram of the different
24、 planes and lines in an ultrasonic field (modified from IEC 61828 and IEC 62127-1)12 Figure A.1 Focusing transducer with a f-number of about 737 Figure A.2 Strongly focusing transducer with a low f-number of about 1.37 Figure A.3 Focusing transducer (f-number 10) with severe undulations close to the
25、 transducer 38 Figure A.4 Focusing transducer .44 Figure A.5 Focusing transducer with smaller aperture than that of Figure A.4 44 Figure A.6 Focusing transducer with a weak focus near zbp45 Figure A.7 Weakly focusing transducer 45 Figure B.1 Example of curved linear array in scanning mode .53 Figure
26、 B.2 Suggested 1 cm 1 cm square-aperture mask56 62359 IEC:2010 3 Figure B.3 Suggested orientation of transducer, mask aperture and RFB target.56 Figure B.4 Suggested orientation of transducer and 1 cm-square RFB target.57 Table 1 Summary of combination formulae for each of the THERMAL INDEX categori
27、es.28 Table 2 Summary of the acoustic quantities required for the determination of the indices29 Table A.1 Thermal index categories and models 36 Table A.2 Consolidated thermal index formulae .41 Table E.1 Summary of differences .63 4 62359 IEC:2010 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ ULTRAS
28、ONICS FIELD CHARACTERIZATION TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical c
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38、ion. 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 responsible for identifying any or all such
39、patent rights. International standard IEC 62359 has been prepared by IEC technical committee 87: Ultrasonics. This second edition cancels and replaces the first edition, published in 2005. It constitutes a technical revision. Major changes with respect to the previous edition include the following:
40、The methods of determination set out in the first edition of this standard were based on those contained in the American standard for RealTime Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (ODS) and were intended to yield identical results. While this s
41、econd edition also follows the ODS in principal and uses the same basic formulae and assumptions (see Annex A), it contains a few significant modifications which deviate from the ODS. 62359 IEC:2010 5 One of the primary issues dealt with in preparing this second edition of IEC 62359 was “missing” TI
42、 equations. In Edition 1 there were not enough equations to make complete “at-surface” and “below-surface” summations for TIS and TIB in combined-operating modes. Thus major changes with respect to the previous edition are related to the introduction of new calculations of thermal indices to take in
43、to account both “at-surface“ and “below-surface“ thermal effects. For the specific technical changes involved please see Annex E. The text of this standard is based on the following documents: FDIS Report on voting 87/445/FDIS 87/453/RVD Full information on the voting for the approval of this standa
44、rd 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. This standard may be used to support the requirements of IEC 60601-2-37. In this particular standard, the following print types are used: require
45、ments, compliance with which can be tested, and definitions: in roman type notes, explanations, advice, introductions, general statements, exceptions, and references: in smaller type test specifications: in italic type words in bold are defined terms in Clause 3 The committee has decided that the co
46、ntents of this amendment and the base 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, o
47、r amended. IMPORTANT The colour 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 62359 IEC:2010 INTRODUCTION Medic
48、al diagnostic ultrasonic equipment is widely used in clinical practice for imaging and monitoring purposes. Equipment normally operates at frequencies in the low megahertz frequency range and comprises an ultrasonic transducer acoustically coupled to the patient and associated electronics. There is
49、an extremely wide range of different types of systems in current clinical practice. The ultrasound entering the patient interacts with the patients tissue, and this interaction can be considered in terms of both thermal and non-thermal effects. The purpose of this International standard is to specify methods of determining thermal and non-thermal expos
