IEC TS 62736:2023

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and withdrawn publications.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
...