IEC 61391-2:2010

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

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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
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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
...