IEC TS 62736:2023
(Main)Ultrasonics - Pulse-echo scanners - Simple methods for periodic testing to verify stability of an imaging system's elementary performance
Ultrasonics - Pulse-echo scanners - Simple methods for periodic testing to verify stability of an imaging system's elementary performance
IEC TS 62736:2023 specifies requirements and methods for periodic testing of the quality of diagnostic medical ultrasound systems using reflection-mode (pulse-echo) imaging. Image measurement and interpretation workstations are included. This document includes minimum sets of such tests intended for frequent users of medical ultrasound systems, for quality assurance professionals in their organizations, or those hired from other quality-control and/or service-provider organizations. The procedures are for a wide range of more common diagnostic ultrasound systems, currently operating from 1 MHz to 40 MHz, although available phantoms meet the specifications only from 1 MHz to 23 MHz.
The tests are defined in three levels, with the simplest and most cost-effective performed most frequently:
- Level 1 comprises five quick tests/observations to be performed daily to monthly by those normally operating the systems.
- Level 2 includes one necessary test for all systems in addition to those of Level 1, two Level 1 tests performed more rigorously, two tests that are for special situations or equipment, and one that is just optional, included because it is highly developed. Level 2 tests are performed annually by those with meaningful quality assurance training.
- Level 3 extends the two special situations tests to all systems, adds one optional test and includes a periodic review of the QA programme.
Frequent distance-measurement accuracy tests are recommended in this document only for certain classes of position encoding that are not now known to be highly stable and without bias. QA in all dimensions is recommended in this document as the first test for such systems.
The test methodology is applicable for transducers operating in the 1 MHz to 23 MHz frequency range. The types of transducers used with these scanners include
a) electronic phased arrays,
b) linear arrays,
c) convex arrays,
d) mechanical transducers,
e) two-dimensional arrays operated in a 2D imaging mode,
f) transducers operating in 3D imaging mode for a limited number of sets of reconstructed 2D images, and
g) three-dimensional scanning transducers based on a combination of the above types.
All tests on scanners considered here evaluate basic pulse-echo techniques and might detect most failures in other modes. Dedicated Doppler systems, or other systems for detection of blood motion, are excluded from this scope as specialized equipment is required to test them. Such test equipment can be specific to the intended application of the Doppler system. This document includes definition of terms and specifies methods for measuring the maximum relative depth of penetration of real-time ultrasound B MODE scanners, though this penetration measure is listed as less frequently applied.
IEC TS 62736:2023 cancels and replaces the first edition published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) expansion of the applicable types of transducers and the frequency range of application;
b) extension of test protocols and image assessments, including for very-low-echo spheres;
c) revision of phantom designs and their acoustic properties, consistent with the second edition of IEC TS 62791;
d) inclusion of luminance tests for system-image display consistency at scanner and remote monitors;
e) addition of special considerations for 3D-imaging transducers (Annex D) and workbook examples (Annex E).
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IEC TS 62736 ®
Edition 2.0 2023-01
TECHNICAL
SPECIFICATION
colour
inside
Ultrasonics – Pulse-echo scanners –
Simple methods for periodic testing to verify stability of an imaging system's
elementary performance
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 IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
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3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
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.
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IEC TS 62736 ®
Edition 2.0 2023-01
TECHNICAL
SPECIFICATION
colour
inside
Ultrasonics – Pulse-echo scanners –
Simple methods for periodic testing to verify stability of an imaging system's
elementary performance
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 17.140.50 ISBN 978-2-8322-6345-7
– 2 – IEC TS 62736:2023 © IEC 2023
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 9
2 Normative references . 10
3 Terms and definitions . 10
4 Symbols and abbreviated terms . 14
4.1 Symbols . 14
4.2 Abbreviated terms . 16
5 General recommendation . 17
6 Environmental conditions . 17
7 Quality assurance levels . 18
7.1 General . 18
7.2 Level 1 tests . 19
7.3 Level 2 tests . 19
7.4 Level 3 tests . 20
8 Equipment and data required . 20
8.1 Phantoms and software. 20
8.1.1 General . 20
8.1.2 Phantoms for Level 2 and Level 3 quality assurance . 20
8.1.3 Additional phantom specifications for Level 2 quality assurance . 21
8.1.4 Additional phantom specifications for Level 3 quality assurance and
optional Level 2 tests . 23
8.2 Image data . 24
8.2.1 Digital-image data . 24
8.2.2 Image-archiving systems . 25
8.3 Expectations of system suppliers . 26
9 Level 1 test methods . 26
10 Level 2 measurement methods . 27
10.1 Mechanical inspection . 27
10.2 Image uniformity for transducer element and channel integrity . 27
10.2.1 General . 27
10.2.2 Apparatus scanning procedures and system settings . 27
10.2.3 Image acquisition. 28
10.2.4 Analysis . 29
10.3 Randomly distributed high-contrast sphere visualization . 30
10.3.1 Methodology . 30
10.3.2 Procedure . 33
10.3.3 Data recording . 35
10.4 Image displays; system and interpretation; maximum relative depth of
penetration; spatial resolution . 35
10.5 Distance and other spatial measurements . 35
11 Level 3 measurement methods . 35
11.1 General . 35
11.2 Maximum relative depth of penetration . 36
11.2.1 Assessment . 36
11.2.2 Scanning system settings . 36
11.2.3 Image acquisition. 37
11.2.4 Analysis . 38
11.2.5 Commentary . 39
11.3 System-image display . 40
11.3.1 General . 40
11.3.2 Level 1 tests of the US system and interpretation-station display . 41
11.3.3 Level 2 and Level 3 display tests . 42
11.4 Distance and other spatial measurements . 45
11.4.1 General . 45
11.4.2 Apparatus and scanning system settings . 45
11.4.3 Image acquisition. 45
11.4.4 Analysis . 45
11.5 Performance in clinical use and evaluation of QA programme . 45
Annex A (informative) Example phantoms for full coupling with curved arrays,
particularly for image uniformity tests . 46
Annex B (informative) Available analysis software . 50
B.1 Open source software for assessment or tracking of ultrasound image QA
data . 50
B.2 Example of QA control chart . 52
Annex C (informative) Electronic test methods and test methods provided by the
manufacturers – Relation to clinical significance . 54
Annex D (informative) Special considerations for 3D imaging transducers . 55
D.1 General . 55
D.2 2D transducers and 3D mechanically driven transducers operating in 2D
imaging mode . 55
D.3 2D arrays operating in 3D imaging mode for determining LSNR values for
md
reconstructed images as a function of depth or distance from the central
plane . 55
D.4 Mechanically driven 3D transducers operating in 3D imaging mode . 55
Annex E (informative) Example workbook database for tracking high-contrast, low-
echo sphere visibility and luminance of the display . 56
Bibliography . 63
Figure 1 – Median-averaged image (right) and its lateral profile (left) . 30
Figure 2 – Examples of portable apparatus for moving the transducer: a) and c) in
equal, chosen increments or b) at a known rate . 32
Figure 3 – Example of visual estimation of the two defined depth zones in which
spheres can be detected with two degrees of fidelity and clarity . 33
Figure 4 – Additional examples of visual estimation of the depth Zone 1 and Zone 2,
each of which represents a certain degree of fidelity and clarity (IEC 62791) . 34
Figure 5 – Maximum relative depth of penetration – image acquisition . 37
Figure 6 – Mean digitized image-data value versus depth for the phantom image data
(A(j)) and for the noise-image data (A'(j)) . 39
Figure 7 – TG18-QA test pattern for visual evaluation testing [21],[33] . 41
Figure 8 – Examples of TG18-LN luminance patterns for luminance measurements [21] . 42
Figure 9 – TG270-ULN uniformity and luminance test pattern (TG270-ULN8-127 with
background 8-bit grey level 127 is shown) [33] . 44
Figure A.1 – Example phantom for image-uniformity and maximum relative depth of
penetration tests . 46
– 4 – IEC TS 62736:2023 © IEC 2023
Figure A.2 – Example compact phantom for image uniformity tests . 47
Figure A.3 – Photograph and drawing of a three-in-one phantom which provides for
determination of distance measurement precision and bias, image-uniformity, very-low-
echo sphere visualization, and depth of penetration [39] . 48
Figure A.4 – Two temporally stable, inexpensive phantoms for image uniformity tests . 49
Figure B.1 – Example of data analysis for the transducer evaluated to generate
Figure 1 .
...
IEC TS 62736 ®
Edition 2.0 2023-01
REDLINE VERSION
TECHNICAL
SPECIFICATION
colour
inside
Ultrasonics – Pulse-echo scanners –
Simple methods for periodic testing to verify stability of an imaging system's
elementary performance
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 IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
IEC Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
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 corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always have
committee, …). It also gives information on projects, replaced access to up to date content tailored to your needs.
and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 300 terminological entries in English
details all new publications released. Available online and once
and French, with equivalent terms in 19 additional languages.
a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or need
further assistance, please contact the Customer Service
Centre: sales@iec.ch.
IEC TS 62736 ®
Edition 2.0 2023-01
REDLINE VERSION
TECHNICAL
SPECIFICATION
colour
inside
Ultrasonics – Pulse-echo scanners –
Simple methods for periodic testing to verify stability of an imaging system's
elementary performance
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 17.140.50 ISBN 978-2-8322-6369-3
– 2 – IEC TS 62736:2023 RLV © IEC 2023
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 9
2 Normative references . 10
3 Terms and definitions . 11
4 Symbols and abbreviated terms . 16
4.1 Symbols . 16
4.2 Abbreviated terms . 17
5 General recommendation . 18
6 Environmental conditions . 18
7 Quality control assurance levels . 19
7.1 General . 19
7.2 Level 1 tests . 21
7.3 Level 2 tests . 21
7.4 Level 3 tests . 22
8 Equipment and data required . 22
8.1 Phantoms and software. 22
8.1.1 General . 22
8.1.2 Phantoms for Level 2 and/or Level 3 quality control assurance . 23
8.1.3 Additional phantom specifications for Level 2 quality control assurance
only . 23
8.1.4 Additional phantom specifications for both Level 2 and Level 3 quality
control assurance and optional Level 2 tests . 26
8.2 Image data . 27
8.2.1 Digital-image data . 27
8.2.2 Image-archiving systems . 28
8.3 Expectations of system suppliers . 29
9 Level 1 test methods . 30
10 Level 2 measurement methods . 30
10.1 Mechanical inspection . 30
10.2 Image uniformity for transducer element and channel integrity . 30
10.2.1 General . 30
10.2.2 Apparatus scanning procedures and system settings . 30
10.2.3 Image acquisition. 32
10.2.4 Analysis . 32
10.3 Randomly distributed high-contrast sphere visualization . 34
10.3.1 Methodology . 34
10.3.2 Procedure . 36
10.3.3 Data recording . 38
10.4 Image displays; system and interpretation; maximum relative depth of
penetration; spatial resolution . 38
10.5 Distance and other spatial measurements . 38
11 Level 3 measurement methods . 38
11.1 General . 38
11.2 Maximum relative depth of penetration . 39
11.2.1 Assessment . 39
11.2.2 Scanning system settings . 39
11.2.3 Image acquisition. 40
11.2.4 Analysis . 41
11.2.5 Commentary . 42
11.3 System-image display . 43
11.3.1 General . 43
11.3.2 Level 1 tests of the US system and interpretation-station display . 44
11.3.3 Level 2 and Level 3 display tests . 45
11.4 Distance and other spatial measurements for mechanically scanned
distances . 49
11.4.1 General . 49
11.4.2 Apparatus and scanning system settings . 49
11.4.3 Image acquisition. 50
11.4.4 Analysis . 50
11.5 Performance in clinical use and evaluation of QA programme . 50
Annex A (informative) Example phantoms for full coupling with curved arrays,
particularly for image uniformity and/or maximum relative depth of penetration tests . 51
Annex B (informative) Available analysis software . 55
B.1 Open source software for assessment for QC or tracking of ultrasound
image uniformity QA data . 55
B.2 Example of QC QA control chart . 57
Annex C (informative) Display test patterns .
Annex C (informative) Electronic test methods and test methods provided by the
manufacturers – Relation to clinical significance . 61
Annex D (informative) Special considerations for 3D imaging transducers . 62
D.1 General . 62
D.2 2D transducers and 3D mechanically driven transducers operating in 2D
imaging mode . 62
D.3 2D arrays operating in 3D imaging mode for determining LSNR values for
md
reconstructed images as a function of depth or distance from the central
plane . 62
D.4 Mechanically driven 3D transducers operating in 3D imaging mode . 62
Annex E (informative) Example workbook database for tracking high-contrast, low-
echo sphere visibility and luminance of the display . 63
Bibliography . 70
Figure 1 – Median-averaged image (right) and its lateral profile (left) . 33
Figure 2 – Examples of portable apparatus for moving the transducer: a) and c) in
equal, chosen increments or b) at a known rate . 35
Figure 3 – Example of visual estimation of the two defined depth zones in which
spheres can be detected with two degrees of fidelity and clarity . 36
Figure 4 – Additional examples of visual estimation of the depth Zone 1 and Zone 2,
each of which represents a certain degree of fidelity and clarity (IEC 62791) . 37
Figure 5 – Maximum relative depth of penetration – image acquisition . 40
Figure 6 – Mean digitized image-data value versus depth for the phantom image data
(A(j)) and for the noise-image data (A'(j)) . 42
Figure 7 – TG18-QA test pattern for visual evaluation testing [21],[33] . 45
Figure 8 – Examples of TG18-LN luminance patterns for luminance measurements [21] . 47
– 4 – IEC TS 62736:2023 RLV © IEC 2023
Figure 9 – TG270-ULN uniformity and luminance test pattern (TG270-ULN8-127 with
background 8-bit grey level 127 is shown) [33] . 48
Figure A.1 – Example phantom for image-uniformity and/or maximum relative depth of
penetration tests . 51
Figure A.2 – Example compact phantom for image uniformity tests . 52
Figure A.3 –Photograph and drawing of a three-in-one phantom which provides for
determination of distance measurement precision and bias, image-uniformity, very-low-
echo sphere visualization, and depth of penetration [39] . 53
Figure A.4 – A compact uniformity phantom of relatively durable rubber material .
Figure A.4 – Two temporally stab
...
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