1、 IEC 61689 Edition 3.0 2013-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Ultrasonics Physiotherapy systems Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz Ultrasons Systmes de physiothrapie Spcifications des champs et mthodes de mesure dans la gamme de frque
2、nces de 0,5 MHz 5 MHz IEC61689:2013 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2013 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying
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16、0 2013-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Ultrasonics Physiotherapy systems Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz Ultrasons Systmes de physiothrapie Spcifications des champs et mthodes de mesure dans la gamme de frquences de 0,5 MHz 5 MHz
17、 INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XB ICS 11.040.60 PRICE CODE CODE PRIX ISBN 978-2-83220-657-7 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure th
18、at you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 61689 IEC:2013 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 Scope . 7 2 Normative references . 7 3 Terms and definitions . 8 4 List of symbo
19、ls . 16 5 Ultrasonic field specifications . 18 6 Conditions of measurement and test equipment used . 19 6.1 General . 19 6.2 Test vessel 19 6.3 Hydrophone . 20 6.4 rms or peak signal measurement . 20 7 Type testing reference procedures and measurements . 20 7.1 General . 20 7.2 Rated output power .
20、21 7.3 Hydrophone measurements . 21 7.4 Effective radiating area 22 7.5 Reference type testing parameters 23 7.6 Acceptance criteria for reference type testing 24 8 Routine measurement procedure 24 8.1 General . 24 8.2 Rated output power . 24 8.3 Effective radiating area 25 8.4 Beam non-uniformity r
21、atio . 25 8.5 Effective intensity 25 8.6 Acceptance criteria for routine testing . 25 9 Sampling and uncertainty determination . 26 9.1 Reference type testing measurements . 26 9.2 Routine measurements 26 9.3 Uncertainty determination 26 Annex A (informative) Guidance for performance and safety 27 A
22、nnex B (normative) Raster scan measurement and analysis procedures 31 Annex C (normative) Diametrical or line scan measurement and analysis procedures 33 Annex D (informative) Rationale concerning the beam cross-sectional area definition 36 Annex E (informative) Factor used to convert the beam cross
23、-sectional area (ABCS) at the face of the treatment head to the effective radiating area (AER) 41 Annex F (informative) Determining acoustic power through radiation force measurements 43 Annex G (informative) Validity of low-power measurements of the beam cross-sectional area (ABCS) 45 Annex H (info
24、rmative) Influence of hydrophone effective diameter . 46 Annex I (informative) Effective radiating area measurement using a radiation force balance and absorbing apertures 48 61689 IEC:2013 3 Annex J (informative) Guidance on uncertainty determination 58 Bibliography 60 Figure A.1 Normalized, time-a
25、veraged values of acoustic intensity (unbroken line) and of one of its plane-wave approximations (broken line), existing on the axis of a circular piston source of ka = 30, versus the normalized distance sn, where sn= z/a2. 30 Figure A.2 Histogram of RBNvalues for 37 treatment heads of various diame
26、ter and frequency 30 Figure D.1 Iso-pressure lines of a typical physiotherapy treatment head of small geometrical area (ka = 17) 38 Figure D.2 Plot of beam cross-sectional area against different limit values for a small range of values in distance along the beam alignment axis, z 38 Figure D.3 Norma
27、lized values of beam cross-sectional area for IEC and FDA limit values for five transducers of different ka values . 39 Figure D.4 Range of values of the beam cross-sectional area (ABCS) with distance from the face of the treatment head 40 Figure D.5 Range of values of the normalized beam cross-sect
28、ional area (ABCS) with transducer ka 40 Figure E.1 Conversion factor Facas a function of the ka product for ka product between 40 and 160 . 42 Figure I.1 Schematic representation of aperture measurement set-up 49 Figure I.2 Measured power as a function of aperture diameter for commercially-available
29、 1 MHz physiotherapy treatment heads . 53 Figure I.3 Cumulative sum of annular power contributions, previously sorted in descending order of intensity contribution, plotted against the cumulative sum of their respective annular areas . 56 Table C.1 Constitution of the transformed array B used for th
30、e analysis of half-line scans 34 Table F.1 Necessary target size, expressed as the minimum target radius b, as a function of the ultrasonic frequency, f, the effective radius of the treatment head, a1, and the target distance, z, calculated according to A.5.3 of IEC 61161: 2013 (see 6) 44 Table G.1
31、Variation of the beam cross-sectional area (ABCS(z) with the indicated output power from two transducers . 45 Table H.1 Comparison of measurements of the beam cross-sectional area (ABCS(z) made using hydrophones of geometrical active element radii 0,3 mm, 0,5 mm and 2,0 mm . 47 Table I.1 Aperture me
32、asurement check sheet 52 Table I.2 Annular power contributions 54 Table I.3 Annular intensity contributions. 54 Table I.4 Annular intensity contributions, sorted in descending order . 55 Table I.5 Annular power contributions, sorted in descending order of intensity contribution . 55 Table I.6 Cumula
33、tive sum of annular power contributions, previously sorted in descending order of intensity contribution, and the cumulative sum of their respective annular areas 56 4 61689 IEC:2013 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ ULTRASONICS PHYSIOTHERAPY SYSTEMS FIELD SPECIFICATIONS AND METHODS OF MEA
34、SUREMENT IN THE FREQUENCY RANGE 0,5 MHz TO 5 MHz FOREWORD 1) The 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 o
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44、ublication. 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. International Standard IEC 61689 has been prepared by IEC technical committee 8
45、7: Ultrasonics. This third edition cancels and replaces the second edition published in 2007. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: restriction introduced of 0,2 W/cm2effective intensity during hyd
46、rophone measurements for treatment heads with ka 20, to limit the likelihood of cavitation; a change in the factor Fac, to determine the effective radiating area, from 1,354 to 1,333; change to SI units for terms and definitions; closer alignment and re-ordered, updated definitions in line with stan
47、dards in IEC 62127 series; 61689 IEC:2013 5 minor arithmetical errors corrected in data analysis; inconsistencies and errors in symbol usage removed throughout; large number of editorial and formal corrections made; changes introduced to references in the bibliography. This standard should be read i
48、n conjunction with IEC 60601-2-5, which, as indicated in its preface, will itself be revised in order to be compatible with this standard. The text of this standard is based on the following documents: FDIS Report on voting 87/522/FDIS 87/529/RVD Full information on the voting for the approval of th
49、is 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. NOTE The following print types are used: Requirements: in Arial 10 point Notes: in Arial 8 point Words in bold in the text are defined in Clause 3 Symbols and formulae: Times New Roman + Italic Compliance clauses :
