IEC TR 61390:2022

Ultrasonics - Real-time pulse-echo systems - Test procedures to determine performance specifications

IEC TR 61390:2022 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.
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.
IEC TR 61390:2022 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.

General Information

• Status: Published
• Publication Date: 05-Sep-2022
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: TC 87 - Ultrasonics
• Drafting Committee: WG 9 - TC 87/WG 9
• Current Stage: PPUB - Publication issued
• Start Date: 11-Oct-2022
• Completion Date: 06-Sep-2022

Standards Content (Sample)

IEC TR 61390 ®
Edition 2.0 2022-09
TECHNICAL
REPORT
colour
inside
Ultrasonics – Real-time pulse-echo systems –
Test procedures to determine performance specifications
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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

– 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

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
– 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

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
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