IEC TR 61390:2022

IEC TR 61390
®

Edition 2.0 2022-09
TECHNICAL
REPORT

colour
inside


Ultrasonics – Real-time pulse-echo systems –
Test procedures to determine performance specifications
IEC TR 61390:2022-09(en)

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IEC TR 61390

®


Edition 2.0 2022-09




TECHNICAL



REPORT









colour

inside










Ultrasonics – Real-time pulse-echo systems –

Test procedures to determine performance specifications



























INTERNATIONAL

ELECTROTECHNICAL


COMMISSION





ICS 11.040.50 ISBN 978-2-8322-5638-1




  Warning! Make sure that you obtained this publication from an authorized distributor.


® Registered trademark of the International Electrotechnical Commission

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– 2 – IEC TR 61390:2022 © IEC 2022
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Environmental conditions . 18
5 Recommended equipment . 19
6 Test methods . 19
6.1 Instruments . 19
6.1.1 General . 19
6.1.2 Hydrophones . 19
6.1.3 Oscilloscope or other transient recorder . 19
6.1.4 Spectrum analyzer . 20
6.1.5 Pulse generator . 20
6.1.6 Tissue-mimicking test objects . 20
6.1.7 Tank and degassed water . 20
6.1.8 High or low reflective target . 20
6.1.9 Target holder and/or positioning system . 20
6.1.10 Computing system to run computer-assisted evaluation software . 21
6.1.11 Software to evaluate quality parameters . 21
6.2 Test settings . 21
6.2.1 General . 21
6.2.2 Display settings (focus, brilliance, contrast) . 21
6.2.3 Sensitivity settings (frequency, suppression, output power, overall gain,
TGC, automatic TGC) . 21
6.2.4 Final optimisation . 22
6.2.5 Recording system . 22
6.3 Tested quantities / parameters and procedures . 22
6.3.1 General . 22
6.3.2 Acoustic working-frequency bandwidth . 23
6.3.3 Resolution . 23
6.3.4 Contrast-detail resolution . 25
6.3.5 Non- or minimally-scattering region detectability . 25
6.3.6 Dead zone and proximal and distal working limits . 28
6.3.7 Slice thickness. 28
6.3.8 Depth of penetration . 28
6.3.9 Displayed dynamic range . 29
6.3.10 Display error or position recording error . 29
6.3.11 Measurement system accuracy . 29
6.3.12 M-mode calibration . 30
6.3.13 Beam shape . 30
6.3.14 Uniformity-degradation (element or channel) test . 31
Annex A (informative) Test objects and tissue-mimicking material . 32
A.1 Test object structures . 32
A.2 Tissue-mimicking materials . 32
A.3 Description of test objects . 32

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IEC TR 61390:2022 © IEC 2022 – 3 –
A.3.1 Soft tissue-mimicking test object . 32
A.3.2 Axial resolution test object . 33
A.3.3 Multi-purpose resolution test object . 34
A.3.4 Contrast test objects . 36
A.3.5 Low-scattering sphere void test object . 37
A.3.6 Randomly positioned, embedded low-echo spheres phantom . 38
A.3.7 Cylindrical-void phantom . 39
A.3.8 Edinburgh pipe phantom . 40
A.3.9 Crossed-threads phantom . 42
Annex B (informative) Test procedures . 47
B.1 Analysis of random-void phantoms . 47
B.1.1 Automated segmentation and sorting of voids . 47
B.1.2 Procedure for detecting voids and assigning contrast-scaled spherical
objects to them for display of the best imaging zones . 48
B.2 Analysis of beam profiles using cross-threads phantoms . 50
B.2.1 Test procedure for crossed-threads phantom . 50
B.2.2 Analysis of display sonic contrast when using a foam phantom . 50
Bibliography . 53

Figure 1 – Beam geometry . 11
Figure 2 – Reticulated foam with random voids . 26
Figure A.1 – Soft tissue-mimicking test object . 33
Figure A.2 – Axial resolution test object . 34
Figure A.3 – Multi-purpose resolution test object . 35
Figure A.4 – Slice-thickness measurement and calculation . 36
Figure A.5 – Contrast test object . 37
Figure A.6 – Non-scattering spheres test object . 38
Figure A.7 – End view of the phantom applicable for 2 MHz to 7 MHz showing the
spatially random distribution of 4-mm diameter spheres . 39
Figure A.8 – Essential components of Satrapa's cylindical-void phantom . 40
Figure A.9 – Structures of foams . 40
Figure A.10 – Schematic of Edinburgh pipe phantom showing anechoic pipes within
the tissue mimicking material . 41
Figure A.11 – Image from a preclinical ultrasound scanner operating at 55 MHz
showing the length over which a 92-micron pipe can be visualised in the scan plane . 42
Figure A.12 – 3D-thread phantom . 43
Figure A.13 – Beam profiles calculated from the single-filament images . 43
Figure A.14 – Thread groups with threads stretched at 45º angles to each other . 44
Figure A.15 – (above) Azimuthal and elevational beam profiles obtained from a

filament phantom; (below) Constant depth (C-images) from a random-void phantom. 45
Figure A.16 – Beam profiles calculated for a matrix probe . 45
Figure B.1 – Segmentation of voids performed following void contrast (void signal
amplitude) ranking and transfer in small spheres like a “container” to the corresponding
contrast fraction . 48
Figure B.2 – WCR-plot for 10 fractions with the reference level set to 70 . 49
Figure B.3 – Screen shots of rotating volume images of a random-void phantom using
gray-scale (left) and VDR -levels (right) in transparent mode . 49
i

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– 4 – IEC TR 61390:2022 © IEC 2022
Figure B.4 – Screen shot of a rotating-volume image of random-void phantom after
automatic segmentation . 50
Figure B.5 – Determination of display sonic contrast (symbolic) . 51
Figure B.6 – Result of 3D-display sonic contrast determination (example) . 51
Figure B.7 – A Signal-to-Noise Ratio (SNR) chart, giving only "signal“ without "noise“,

expressed in dB . 52

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IEC TR 61390:2022 © IEC 2022 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ULTRASONICS – REAL-TIME PULSE-ECHO SYSTEMS –

Test procedures to determine performance specifications

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
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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.
IEC TR 61390 has been prepared by IEC technical committee 87: Ultrasonics. It is a Technical
Report.
This second edition cancels and replaces the first edition published in 1996. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) Several additional phantom designs are included in the main body of the document;
b) Several additional transducer types are included in the Scope;
c) Methods of analysis are presented in new Annex B.

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– 6 – IEC TR 61390:2022 © IEC 2022
The text of this Technical Report is based on the following documents:
Draft Report on voting
87/771/DTR 87/796A/RVDTR

Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Technical Report is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
NOTE Words in bold in the text are defined in Clause 3.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

IMPORTANT – The "colour inside" logo on the cover page of this document 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.

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IEC TR 61390:2022 © IEC 2022 – 7 –
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 at tissue boundaries. Furthermore, the number of ultrasonic pulse-echo scanners
using plane-wave imaging technology is increasing.
Alternatively, a scanner can transmit a wide-field wave-front or several transmit-beams and
record from the whole transducer array the echoes backscattered from tissue boundaries [1]
1
[2] . The latter is followed by software beamforming, picking several parts of the wide beam or
in this way selecting one of the simultaneously transmitted beams to obtain adequate resolution.
Plane-wave techniques cannot compete with physical, transmit beam-forming for maximum
depth of imaging at a given bandwidth, maximum resolution and minimum acoustic exposure.
Ultrasonic scanners are widely used in medical practice to produce images of many soft-tissue
organs throughout the human body. A variety of transducer types is employed to operate in a
transmit/receive mode for generating/receiving the ultrasonic signals.
This document describes test procedures that should be widely acceptable and valid for a wide
range of types of equipment. Manufacturers should use this document to prepare their own
specifications, while users should use this document to check manufacturers’ specifications.
The measurements can be carried out without interfering with the normal working conditions of
the machine. The structures of the test objects, test equipment and measuring systems have
not been specified in detail; rather, suitable types of overall and internal structures are
described, together with typical test objects, in Annex A. The specific structure of a test object
and test equipment should be reported, together with the results obtained using them. Similar
commercial versions of these test objects are available.
The performance parameters selected and the corresponding methods of measurement have
been chosen to provide a basis for comparison with the manufacturers’ specifications and
between similar types of apparatus of different makes, intended for the same kind of diagnostic
application. The manufacturers’ specifications should allow comparison with the results
obtained from the tests described in this document. Specific values of parameters and the
tolerances on them have not been recommended, since these are constantly changing.
Furthermore, it is intended that the sets of results and values obtained from the use of the
recommended methods will provide useful criteria for predicting the performance of equipment
in appropriate diagnostic applications.
The procedures recommended in this document are in accordance with IEC 60601-1:2005.
Where a diagnostic system accommodates more than one option in respect of a particular
system component, for example the transducer, it is intended that each option be regarded as
a separate system. However, it is considered that the performance of a machine is adequately
specified, if measurements are undertaken for the most significant combinations of machine-
control settings and accessories. Further evaluation of equipment is obviously possible but this
should be considered as a special case rather than a routine requirement.
Data relating to measuring methods, principles and equipment that are common to two or more
sections of this report are given in Annex A. Specific test procedures are given in Annex B.
The measurement of acoustic output power levels and the assessment of electrical safety are
dealt with in other IEC standards; they are therefore specifically excluded from this document.

1
Numbers in square brackets refer to the Bibliography.

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ULTRASONICS – REAL-TIME PULSE-ECHO SYSTEMS –

Test procedures to determine performance specifications



1 Scope
This document describes representative methods of measuring the performance of complete
real-time medical ultrasonic imaging equipment in the frequency range 0,5 MHz to 23 MHz.
NOTE The frequency range given represents, in general, the widely used range in hospitals at the date of
publication; special medical applications use higher frequencies for imaging but mainly in research or pre-clinical
imaging.
This document is relevant for real-time ultrasonic scanners based on the pulse-echo principle,
for the types listed below:
• mechanical sector scanner;
• electronic phased array sector scanner;
• electronic linear array scanner;
• electronic curved array sector scanner;
• water-bath scanner based on any of the above four scanning mechanisms;
• plane-wave/fast imaging scanners;
• combination of several of the above methods (e.g. a linear array phased at the edge to
produce a sector there to enlarge the field of view.
The methods described are based on evaluation of:
• sonograms obtained by scanning of tissue mimicking objects (phantoms);
• sonograms obtained by scanning of artificial, low- or highly reflective targets in suitable
environments;
• parameters of the ultrasound field transmitted by the measured scanner.
This document does not relate to methods for measuring electrical parameters of the scanner’s
electronic systems.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp

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IEC TR 61390:2022 © IEC 2022 – 9 –
3.1
A-scan
class of data acquisition geometry in one dimension, in which echo strength information is
acquired from points lying along a single beam axis and displayed as amplitude versus time of
flight or distance
[SOURCE: IEC 61391-1:2006, 3.1]
3.2
A-mode
amplitude-modulated display
method of presentation of A-scan information in which the ultrasonic transducer-target
distance is represented on one axis (normally horizontal) and the echo amplitude on the other
axis
[SOURCE: IEC TR 60854:1986, 3.17, modified – Replacement of "echo information" with "A-
scan information" and "transducer to target distance" with "ultrasonic transducer-target
distance"]
3.3
acceptance testing
evaluation of system performance after delivery of a purchased or repaired system and before
authorisation for payment
3.4
acoustic clutter
noise artifact in ultrasound images that appears as diffuse echoes overlying signals of interest
Note 1 to entry: Sources of acoustic clutter include sound reverberation in tissue layers, scattering from off-axis
structures, ultrasound beam distortion, returning echoes from previously transmitted pulses and random acoustic or
electronic noise
3.5
acoustic scan line
one of the component lines that form a B-mode image on an ultrasound monitor, where each
line is the envelope-detected A-scan line, in which the echo amplitudes are converted to
brightness values
[SOURCE: IEC 61391-1:2006, 3.26]
3.6
acoustic-working frequency
centre frequency
arithmetic mean of the frequencies f and f at which the amplitude of the acoustic pressure
1 2
spectrum is 3 dB below the peak amplitude
[SOURCE: IEC 61391-1:2006, 3.3]
3.7
axial resolution
minimum separation along the beam axis of two equally scattering volumes or targets at a
specified depth for which two distinct echo signals can be displayed
[SOURCE: IEC 61391-1:2006, 3.5]

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– 10 – IEC TR 61390:2022 © IEC 2022
3.8
B-scan
brightness-modulated display scan
class of data-acquisition geometry in which echo information is acquired from points lying in an
ultrasonic scan plane containing interrogating ultrasonic beams
Note 1 to entry: B-scan is a colloquial term for B-mode scan or image.
3.9
B-mode
brightness-modulated display
method of presentation of B-scan information, in which a particular section through an imaged
object is represented in a conformal way by the plane of the display and echo amplitude is
represented by local brightness or optical density of the display
[SOURCE: IEC 61391-1:2006, 3.10, modified – Replacement of "scan plane" with "plane"]
3.10
backscatter coefficient
at a specified frequency, the mean acoustic power scattered by a specified object in the 180°
direction with respect to the direction of the incident beam, per unit solid angle per unit volume,
divided by the incident beam intensity, the mean power being obtained from different spatial
realizations of the scattering volume
Note 1 to entry: The frequency dependency should be addressed at places where backscatter coefficient is used,
if frequency influences results significantly.
-1 -1
Note 2 to entry: Backscatter coefficient is expressed in units of 1 per metre times 1 per steradian (m sr )”.
[SOURCE: IEC 61391-1:2006, 3.6, modified – In the definition, addition of "at a specified
frequency", and addition of two new Notes to entry]
3.11
backscatter contrast
ratio between the backscatter coefficients of two objects or regions
[SOURCE: IEC 61391-2:2010, 3.8]
3.12
bandwidth
difference in the most widely separated frequencies f and f at which the magnitude of the
1 2
acoustic pressure spectrum drops 3 dB below the peak magnitude, at a specified point in the
acoustic field
Note 1 to entry: Bandwidth is expressed in hertz (Hz).
[SOURCE: IEC 62127-1:2007, 3.6, modified – Replacement of "becomes" with "drops"]
3.13
beam axis
straight lin
...