1、 IEC 61391-2 Edition 1.0 2010-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Ultrasonics Pulse-echo scanners Part 2: Measurement of maximum depth of penetration and local dynamic range Ultrasons Scanners impulsion et cho Partie 2: Mesure de la profondeur maximale de pntration et de la plage dynamiqu
2、e locale IEC 61391-2:2010 colour inside THIS 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 form or by any means, electronic or mechanical, including photocop
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16、uestions, 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 61391-2 Edition 1.0 2010-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Ultrasonics Pulse-echo scanners Part 2: Measurement of maximum depth of penetration and local dynami
17、c range Ultrasons Scanners impulsion et cho Partie 2: Mesure de la profondeur maximale de pntration et de la plage dynamique locale INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE W ICS 17.140.50 PRICE CODE CODE PRIX ISBN 978-2-88912-019-2 Registered trademark of
18、 the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale colour inside 2 61391-2 IEC:2010 CONTENTS FOREWORD.4 INTRODUCTION.6 1 Scope.8 2 Normative references .8 3 Terms and definitions .8 4 General requirement.13 5 Environmental conditions13 6 Equi
19、pment and data required14 6.1 General .14 6.2 Phantoms14 6.2.1 Phantoms required 14 6.2.2 Phantom for maximum depth of penetration.14 6.2.3 Phantoms to estimate local dynamic range15 6.3 Test equipment for measuring local dynamic range .15 6.4 Digitized image data17 7 Measurement methods .19 7.1 Sys
20、tem sensitivity: maximum depth of penetration.19 7.1.1 Scanning system settings 19 7.1.2 Image acquisition 19 7.1.3 Analysis.20 7.2 Local dynamic range .22 7.2.1 Scanning system settings 22 7.2.2 Measurement method 22 7.2.3 Type II testing for measuring local dynamic range .23 7.2.4 Estimating local
21、 dynamic range using backscatter contrast24 Annex A (informative) Phantom for Determining Maximum Depth of Penetration26 Annex B (informative) Local dynamic range using acoustical test objects.28 Bibliography35 Figure 1 Arrangement for measuring local dynamic range using an acoustic-signal injection
22、 technique16 Figure 2 Arrangement for measuring local dynamic range using an acoustically- coupled burst generator 17 Figure 3 Image of the penetration phantom20 Figure 4 Mean digitized image data value vs. depth for the phantom image data (A(j) and for the noise image data (A(j) 21 Figure 5 Digitiz
23、ed-image data vs. attenuator setting during local dynamic range measurements using acoustic signal injection.23 Figure 6 Image of phantom with inclusions (circles) .24 Figure 7 Ensemble-average mean pixel value vs. backscatter contrast of inclusions25 Figure A.1 Phantom for maximum depth of penetrat
24、ion tests26 Figure B.1 Possible arrangement of reflectors for determining local dynamic range .29 Figure B.2 Displayed intensity (or image pixel value) vs. reflector reflection coefficient.30 61391-2 IEC:2010 3 Figure B.3 Flat ended wire test object for determining local dynamic range32 Figure B.4 T
25、he experimentally observed backscattering cross section of flat-ended stainless-steel wires as a function of diameter for three frequencies: 9.6 MHz; : 4.8 MHz; : 2.4 MHz 33.33 4 61391-2 IEC:2010 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ ULTRASONICS PULSE-ECHO SCANNERS Part 2: Measurement of maxim
26、um depth of penetration and local dynamic range 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 on
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36、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 61391-2 has been prepared by IEC technical committee
37、 87: Ultrasonics. This bilingual version, published in 2010-06, corresponds to the English version. The text of this standard is based on the following documents: Enquiry draft Report on voting 87/400/CDV 87/426/RVC Full information on the voting for the approval of this standard can be found in the
38、 report on voting indicated in the above table. 61391-2 IEC:2010 5 The French version of this standard has not been voted upon. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. Terms in bold in the text are defined in Clause 3. A list of all parts of the IEC 61391
39、 series, published under the general title Ultrasonics Pulse-echo scanners, can be found on the IEC website. The committee has decided that the contents 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
40、to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or 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 understand
41、ing of its contents. Users should therefore print this document using a colour printer. 6 61391-2 IEC:2010 INTRODUCTION An ultrasonic pulse-echo scanner produces images of tissue in a scan plane by sweeping a narrow pulsed beam of ultrasound through the section of interest and detecting the echoes g
42、enerated by reflection at tissue boundaries and by scattering within tissues. Various transducer types are employed to operate in a transmit/receive mode to generate/detect the ultrasonic signals. Ultrasonic scanners are widely used in medical practice to produce images of soft-tissue organs through
43、out the human body. This standard is being published in two or more parts: Part 1 deals with techniques for calibrating spatial measurement systems and measurement of system point spread function response; Part 2 deals with measurement of system sensitivity (maximum depth of penetration) and local d
44、ynamic range. This standard describes test procedures for measuring the maximum depth of penetration and the local dynamic range of these imaging systems. Procedures should be widely acceptable and valid for a wide range of types of equipment. Manufacturers should use the standard to prepare their s
45、pecifications; users should employ the standard to check performance against those specifications. The measurements can be carried out without interfering with the normal working conditions of the machine. Typical phantoms are described in Annex A. The structures of the phantoms are not specified in
46、 detail; instead, suitable types of overall and internal structures for phantoms are described. Similar commercial versions of these test objects are available. The specific structure of a test object selected by the user should be reported with the results obtained when using it. The performance pa
47、rameters described herein and the corresponding methods of measurement have been chosen to provide a basis for comparison between similar types of apparatus of different makes but intended for the same kind of diagnostic application. The manufacturers specifications of maximum depth of penetration a
48、nd local dynamic range must allow comparison with the results obtained from the tests described in this standard. It is intended that the sets of results and values obtained from the use of the recommended methods will provide useful criteria for predicting performance with respect to these paramete
49、rs for equipment operating in the 1 MHz to 15 MHz frequency range. However, availability and some specifications of test objects, such that they are similar to tissue in vivo, are still under study for the frequency range 10 MHz to15 MHz. The procedures recommended in this standard are in accordance with IEC 60601-1 1 and IEC 61391-1. Where a diagnostic system accommod
