IEC TS 62736:2016

Ultrasonics - Pulse-echo scanners - Simple methods for periodic testing to verify stability of an imaging system's elementary performance

IEC TS 62736:2016(E) specifies requirements and methods for periodic testing of the quality of diagnostic medical ultrasound systems with linear array, curved linear array, single element, annular array, phased array, matrix linear array transducers and two-dimensional arrays.

General Information

• Status: Published
• Publication Date: 11-Jul-2016
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: TC 87 - Ultrasonics
• Drafting Committee: WG 9 - TC 87/WG 9
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 13-Jan-2023

Relations

• Revised: IEC TS 62736:2023 - Ultrasonics - Pulse-echo scanners - Simple methods for periodic testing to verify stability of an imaging system's elementary performance
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC TS 62736 ®
Edition 1.0 2016-07
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 Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.

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iPad. Vocabulary (IEV) online.

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The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

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Centre: [e-mail].
IEC TS 62736 ®
Edition 1.0 2016-07
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 978-2-8322-3529-4

– 2 – IEC TS 62736:2016 © IEC 2016
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references. 8
3 Terms and definitions . 8
4 General recommendation . 9
5 Environmental conditions . 10
6 Quality control levels . 10
6.1 General . 10
6.2 Level 1 tests . 10
6.3 Level 2 tests . 11
6.4 Level 3 tests . 11
7 Equipment and data required . 12
7.1 General . 12
7.2 Phantoms . 12
7.2.1 Phantoms for Level 2 and/or Level 3 quality control . 12
7.2.2 Phantoms for Level 2 quality control only . 12
7.2.3 Phantoms for both Level 2 and Level 3 quality control . 13
7.3 Image data . 14
7.3.1 Digital-image data . 14
7.3.2 Image-archiving systems . 15
7.4 Expectations of system suppliers . 16
8 Level 1 test methods . 16
9 Level 2 measurement methods . 17
9.1 Mechanical inspection . 17
9.2 Image uniformity for transducer element and channel integrity. 17
9.2.1 General . 17
9.2.2 Apparatus scanning procedures and system settings . 17
9.2.3 Image acquisition . 18
9.2.4 Analysis . 19
10 Level 3 measurement methods . 20
10.1 General . 20
10.2 Maximum relative depth of penetration. 20
10.2.1 Assessment . 20
10.2.2 Scanning system settings . 20
10.2.3 Image acquisition . 21
10.2.4 Analysis . 22
10.2.5 Commentary . 23
10.3 System-image display . 23
10.3.1 General . 23
10.3.2 Level 1 tests of the US-system and interpretation-station display . 23
10.3.3 Level 2 and 3 tests . 23
10.4 Distance measurements for mechanically scanned distances . 24
10.4.1 General . 24
10.4.2 Apparatus and scanning system settings . 25

10.4.3 Image acquisition . 25
10.4.4 Analysis . 25
Annex A (informative) Example phantoms for image uniformity and/or maximum
relative depth of penetration . 26
Annex B (informative) Available analysis software . 29
B.1 Open source software for assessment for QC of ultrasound image uniformity . 29
B.2 Example of QC control chart: . 31
Annex C (informative) Display test patterns . 33
Annex D (informative) Electronic test methods and test methods provided by the
manufacturers; relation to clinical significance . 35
Bibliography . 36

Figure 1 – Median-averaged image (right) and its lateral profile (left) . 19
Figure 2 – A) Image of a uniform section in a tissue-mimicking phantom, bright
rectangle; B) Image displaying electronic noise only, obtained with the operating
controls set the same as for A but with the transducer decoupled from the phantom
[SOURCE: University of Wisconsin] . 21
Figure 3 – Mean digitized image-data value vs. depth for the phantom image data (A(j))
and for the noise-image data (Aʹ(j)) . 22
Figure A.1 – Example phantom for image-uniformity and/or maximum-relative-depth-
of-penetration tests . 26
Figure A.2 – Example compact phantom for image-uniformity tests . 27
Figure A.3 – Photograph and drawing of a three-in-one phantom which provides for
determination of distance measurement precision and bias, image uniformity and
depth of penetration [37] . 27
Figure A.4 – A compact uniformity phantom of relatively durable rubber material . 28
Figure B.1 – On the left the profile of median pixel value is plotted for each image
column in the analysis box shown in the median image on the right for the transducer
in Figure 1, but without the nylon filament obstructing some central elements . 30
Figure B.2 – Control chart for a dip in the middle of the profile for one transducer (TD)
mode C9-4 and the specified serial number (S/N) . 32
Figure C.1 – AAPM TG18-UN10 (left) and TG18-UN80 (right) patterns for luminance
uniformity, colour uniformity, and angular response evaluations [35] . 33
Figure C.2 – Example data entry form for visual display evaluation: left for Figure C.1;
right for Figure C.3. 34
Figure C.3 – TG18-CT low-contrast test pattern for the evaluation of the luminance
response of display systems [35] . 34

Table 1 – Outline of Level 1 tests . 10
Table 2 – Outline of Level 3 tests additional to those in Table 1 . 11
Table B.1 – Output of analysis . 31

– 4 – IEC TS 62736:2016 © IEC 2016
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS – PULSE-ECHO SCANNERS –

Simple methods for periodic testing to verify stability
of an imaging system’s elementary performance

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 in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Commi
...

IEC TS 62736 ®
Edition 1.0 2016-07
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 Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]

CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 15 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: [e-mail].
IEC TS 62736 ®
Edition 1.0 2016-07
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 978-2-8322-3529-4

– 2 – IEC TS 62736:2016 © IEC 2016

CONTENTS
FOREWORD . 4

INTRODUCTION . 6

1 Scope . 7

2 Normative references. 8

3 Terms and definitions . 8

4 General recommendation . 9

5 Environmental conditions . 10
6 Quality control levels . 10
6.1 General . 10
6.2 Level 1 tests . 10
6.3 Level 2 tests . 11
6.4 Level 3 tests . 11
7 Equipment and data required . 12
7.1 General . 12
7.2 Phantoms . 12
7.2.1 Phantoms for Level 2 and/or Level 3 quality control . 12
7.2.2 Phantoms for Level 2 quality control only . 12
7.2.3 Phantoms for both Level 2 and Level 3 quality control . 13
7.3 Image data . 14
7.3.1 Digital-image data . 14
7.3.2 Image-archiving systems . 15
7.4 Expectations of system suppliers . 16
8 Level 1 test methods . 16
9 Level 2 measurement methods . 17
9.1 Mechanical inspection . 17
9.2 Image uniformity for transducer element and channel integrity. 17
9.2.1 General . 17
9.2.2 Apparatus scanning procedures and system settings . 17
9.2.3 Image acquisition . 18
9.2.4 Analysis . 19
10 Level 3 measurement methods . 20

10.1 General . 20
10.2 Maximum relative depth of penetration. 20
10.2.1 Assessment . 20
10.2.2 Scanning system settings . 20
10.2.3 Image acquisition . 21
10.2.4 Analysis . 22
10.2.5 Commentary . 23
10.3 System-image display . 23
10.3.1 General . 23
10.3.2 Level 1 tests of the US-system and interpretation-station display . 23
10.3.3 Level 2 and 3 tests . 23
10.4 Distance measurements for mechanically scanned distances . 24
10.4.1 General . 24
10.4.2 Apparatus and scanning system settings . 25

10.4.3 Image acquisition . 25

10.4.4 Analysis . 25

Annex A (informative) Example phantoms for image uniformity and/or maximum

relative depth of penetration . 26

Annex B (informative) Available analysis software . 29

B.1 Open source software for assessment for QC of ultrasound image uniformity . 29

B.2 Example of QC control chart: . 31

Annex C (informative) Display test patterns . 33

Annex D (informative) Electronic test methods and test methods provided by the
manufacturers; relation to clinical significance . 35

Bibliography . 36

Figure 1 – Median-averaged image (right) and its lateral profile (left) . 19
Figure 2 – A) Image of a uniform section in a tissue-mimicking phantom, bright
rectangle; B) Image displaying electronic noise only, obtained with the operating
controls set the same as for A but with the transducer decoupled from the phantom
[SOURCE: University of Wisconsin] . 21
Figure 3 – Mean digitized image-data value vs. depth for the phantom image data (A(j))
and for the noise-image data (Aʹ(j)) . 22
Figure A.1 – Example phantom for image-uniformity and/or maximum-relative-depth-
of-penetration tests . 26
Figure A.2 – Example compact phantom for image-uniformity tests . 27
Figure A.3 – Photograph and drawing of a three-in-one phantom which provides for
determination of distance measurement precision and bias, image uniformity and
depth of penetration [37] . 27
Figure A.4 – A compact uniformity phantom of relatively durable rubber material . 28
Figure B.1 – On the left the profile of median pixel value is plotted for each image
column in the analysis box shown in the median image on the right for the transducer
in Figure 1, but without the nylon filament obstructing some central elements . 30
Figure B.2 – Control chart for a dip in the middle of the profile for one transducer (TD)
mode C9-4 and the specified serial number (S/N) . 32
Figure C.1 – AAPM TG18-UN10 (left) and TG18-UN80 (right) patterns for luminance
uniformity, colour uniformity, and angular response evaluations [35] . 33
Figure C.2 – Example data entry form for visual display evaluation: left for Figure C.1;
right for Figure C.3. 34
Figure C.3 – TG18-CT low-contrast test pattern for the evaluation of the luminance

response of display systems [35] . 34

Table 1 – Outline of Level 1 tests . 10
Table 2 – Outline of Level 3 tests additional to those in Table 1 . 11
Table B.1 – Output of analysis . 31

– 4 – IEC TS 62736:2016 © IEC 2016

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
ULTRASONICS – PULSE-ECHO SCANNERS –

Simple methods for periodic testing to verify stability

of an imaging system’s elementary performance

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 in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, a
...