IEC 61391-2:2010
(Main)Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
IEC 61391-2:2010 defines terms and specifies methods for measuring the maximum depth of penetration and the local dynamic range of real time ultrasound B MODE scanners. The types of transducers used with these scanners include:
- mechanical probes;
- electronic phased arrays;
- linear arrays;
- curved arrays;
- two-dimensional arrays;
- three-dimensional scanning probes based on a combination of the above types.
All scanners considered are based on pulse-echo techniques. The test methodology is applicable for transducers operating in the 1 MHz to 15 MHz frequency range operating both in fundamental mode and in harmonic modes that extend to 15 MHz. However, testing of harmonic modes above 15 MHz is not covered by this standard.
Ultrasons - Scanners à impulsion et écho - Partie 2: Mesure de la profondeur maximale de pénétration et de la plage dynamique locale
La CEI 61391-2:2010 définit les termes et spécifie les méthodes de mesure de la profondeur maximale de pénétration et de la plage dynamique locale des scanners ultrasoniques en temps réel, en mode B. Les types de transducteurs utilisés avec ces scanners comprennent ce qui suit:
- sondes à balayage mécanique;
- réseaux de phase électroniques;
- réseaux linéaires (barrettes);
- réseaux courbes;
- réseaux bidimensionnels;
- sondes à balayage tridimensionnel, basées sur une combinaison des types ci-dessus.
Tous les scanners considérés sont basés sur les techniques "impulsion et écho". La méthodologie d'essai est applicable aux transducteurs fonctionnant dans la gamme des fréquences entre 1 MHz et 15 MHz, en mode fondamental et en modes harmoniques allant jusqu'à 15 MHz. Toutefois, les essais en modes harmoniques, au-dessus de 15 MHz, ne sont pas couverts par la présente norme.
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IEC 61391-2 ®
Edition 1.0 2010-01
INTERNATIONAL
STANDARD
Ultrasonics – Pulse-echo scanners –
Part 2: Measurement of maximum depth of penetration and local dynamic range
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
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IEC 61391-2 ®
Edition 1.0 2010-01
INTERNATIONAL
STANDARD
Ultrasonics – Pulse-echo scanners –
Part 2: Measurement of maximum depth of penetration and local dynamic range
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
W
ICS 17.140.50 ISBN 978-2-88910-513-7
– 2 – 61391-2 © IEC:2010(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.8
2 Normative references .8
3 Terms and definitions .8
4 General requirement.13
5 Environmental conditions.13
6 Equipment and data required.14
6.1 General .14
6.2 Phantoms.14
6.2.1 Phantoms required .14
6.2.2 Phantom for maximum depth of penetration.14
6.2.3 Phantoms to estimate local dynamic range .15
6.3 Test equipment for measuring local dynamic range .15
6.4 Digitized image data.17
7 Measurement methods .19
7.1 System 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 dynamic range using backscatter contrast.24
Annex A (informative) Phantom for determining maximum depth of penetration .26
Annex B (informative) Local dynamic range using acoustical test objects.28
Bibliography.35
Figure 1 – Arrangement for measuring local dynamic range using an acoustic-signal
injection technique.16
Figure 2 – Arrangement for measuring local dynamic range using an acoustically-
coupled burst generator .17
Figure 3 – Image of the penetration phantom.20
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 – Digitized-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 inclusions.25
Figure A.1 – Phantom for maximum depth of penetration tests.26
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
Figure B.3 – Flat ended wire test object for determining local dynamic range.32
61391-2 © IEC:2010(E) – 3 –
Figure B.4 – The experimentally observed backscattering cross section of flat-ended
stainless-steel wires as a function of diameter for three frequencies: U 9.6 MHz; :
4.8 MHz; ‘: 2.4 MHz [33].33
– 4 – 61391-2 © IEC:2010(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS –
PULSE-ECHO SCANNERS –
Part 2: Measurement of maximum 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 all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; 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 collaborates 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 the 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 that 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 end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum 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 bodies 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 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
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) 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 87:
Ultrasonics.
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 report on
voting indicated in the above table.
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.
61391-2 © IEC:2010(E) – 5 –
A list of all parts of the IEC 61391 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 maintenance result 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.
A bilingual version of this standard may be issued at a later date.
– 6 – 61391-2 © IEC:2010(E)
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
generated 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 throughout 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 dynamic 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 specifications; 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 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 parameters 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
manufacturer’s specification
...
IEC 61391-2 ®
Edition 1.0 2010-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Ultrasonics – Pulse-echo scanners –
Part 2: Measurement of maximum depth of penetration and local dynamic range
Ultrasons – Scanners à impulsion et écho –
Partie 2: Mesure de la profondeur maximale de pénétration et de la plage
dynamique locale
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 and microfilm, without permission in writing from either IEC or
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publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
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Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
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in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
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IEC 61391-2 ®
Edition 1.0 2010-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Ultrasonics – Pulse-echo scanners –
Part 2: Measurement of maximum depth of penetration and local dynamic range
Ultrasons – Scanners à impulsion et écho –
Partie 2: Mesure de la profondeur maximale de pénétration et de la plage
dynamique locale
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 17.140.50 ISBN 978-2-88912-019-2
– 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 conditions.13
6 Equipment and data required.14
6.1 General .14
6.2 Phantoms.14
6.2.1 Phantoms required .14
6.2.2 Phantom for maximum depth of penetration.14
6.2.3 Phantoms to estimate local dynamic range .15
6.3 Test equipment for measuring local dynamic range .15
6.4 Digitized image data.17
7 Measurement methods .19
7.1 System 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 dynamic range using backscatter contrast.24
Annex A (informative) Phantom for Determining Maximum Depth of Penetration.26
Annex B (informative) Local dynamic range using acoustical test objects.28
Bibliography.35
Figure 1 – Arrangement for measuring local dynamic range using an acoustic-signal
injection technique.
Figure 2 – Arrangement for measuring local dynamic range using an acoustically-
coupled burst generator .17
Figure 3 – Image of the penetration phantom.20
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 – Digitized-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 inclusions .25
Figure A.1 – Phantom for maximum depth of penetration tests.26
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 range.32
Figure B.4 – The experimentally observed backscattering cross section of flat-ended
stainless-steel wires as a function of diameter for three frequencies: U 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 maximum 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 all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; 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 collaborates 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 the 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 that 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 end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum 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 bodies 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 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
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) 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 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 report on
voting indicated in the above table.
...
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