IEC 61675-1:2022

Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs

IEC 61675-1:2022 specifies terminology and test methods for declaring the characteristics of POSITRON EMISSION TOMOGRAPHS. POSITRON EMISSION TOMOGRAPHS detect the ANNIHILATION RADIATION of positron emitting RADIONUCLIDES by COINCIDENCE DETECTION. IEC 61675-1:2022 cancels and replaces the second edition published in 2013. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition: requirements have been changed or newly created regarding the technical aspects of SPATIAL RESOLUTION, sensitivity measurement, SCATTER FRACTION, COUNT RATE performance, image quality, PET/CT registration accuracy and time-of-flight resolution.

Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie 1: Tomographes à émission de positrons

L'IEC 61675-1:2022 spécifie la terminologie et les méthodes d'essai relatives à la description des caractéristiques des TOMOGRAPHES A EMISSION DE POSITRONS. Les TOMOGRAPHES A EMISSION DE POSITRONS détectent le RAYONNEMENT D'ANNIHILATION des RADIONUCLEIDES qui émettent des positrons par la DETECTION EN COÏNCIDENCE. L'IEC 61675-1:2022 annule et remplace la deuxième édition parue en 2013. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: des exigences ont été modifiées ou ajoutées quant aux aspects techniques de la RESOLUTION SPATIALE, du mesurage de la sensibilité, de la FRACTION DE DIFFUSION, de la performance du TAUX DE COMPTAGE, de la qualité d'image et de l’exactitude de la superposition d’images en TEP ou CT.

General Information

• Status: Published
• Publication Date: 17-Mar-2022
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
• Drafting Committee: WG 2 - TC 62/SC 62C/WG 2
• Current Stage: PPUB - Publication issued
• Start Date: 18-Apr-2022
• Completion Date: 18-Mar-2022

Relations

• Revises: IEC 61675-1:2013 - Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 61675-1 ®
Edition 3.0 2022-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Radionuclide imaging devices – Characteristics and test conditions –
Part 1: Positron emission tomographs

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
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International Standards for all electrical, electronic and related technologies.

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IEC 61675-1 ®
Edition 3.0 2022-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Radionuclide imaging devices – Characteristics and test conditions –
Part 1: Positron emission tomographs
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-5071-6

– 2 – IEC 61675-1:2022 RLV © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Test methods . 13
4.1 General . 13
4.2 SPATIAL RESOLUTION . 13
4.2.1 General . 13
4.2.2 Purpose . 14
4.2.3 Method . 14
4.2.4 Analysis . 15
4.2.5 Report . 19
4.3 Tomographic sensitivity . 20
4.3.1 General . 20
4.3.2 Purpose . 20
4.3.3 Method . 20
4.3.4 Analysis . 22
4.3.5 Report . 22
4.4 Uniformity .
4.4 Scatter measurement . 22
4.4.1 General . 23
4.4.2 Purpose . 23
4.4.3 Method . 23
4.4.4 Analysis . 24
4.4.5 Report . 26
4.5 PET COUNT RATE PERFORMANCE . 26
4.5.1 General . 26
4.5.2 Purpose . 26
4.5.3 Method . 26
4.5.4 Analysis . 28
4.5.5 Report . 30
4.6 Time-of-flight resolution . 31
4.6.1 General . 31
4.6.2 Purpose . 31
4.6.3 Method . 31
4.6.4 Radionuclide, source distribution and data collection . 31
4.6.5 Data processing . 31
4.6.6 Analysis . 32
4.6.7 Scatter and random removal . 33
4.6.8 FWHM analysis. 34
4.6.9 Report . 34
4.7 Image quality and quantification accuracy of source ACTIVITY concentrations
and PET/CT registration accuracy . 34
4.7.1 General . 34
4.7.2 Purpose . 34

4.7.3 Method . 34
4.7.4 Data analysis . 40
4.7.5 Report . 44
5 ACCOMPANYING DOCUMENTS . 45
5.1 General . 45
5.2 Design parameters and configuration . 45
5.3 SPATIAL RESOLUTION . 45
5.4 Sensitivity . 46
5.5 SCATTER FRACTION . 46
5.6 COUNT RATE performance . 46
5.7 TIME-OF-FLIGHT resolution . 46
5.8 Image quality and quantification accuracy of source ACTIVITY concentrations . 46
Bibliography . 47
Index of defined terms . 48

Figure 1 – Evaluation of FWHM . 17
Figure 2 – Evaluation of EQUIVALENT WIDTH (EW) . 19
Figure 3 – Scatter phantom configuration and position on the imaging bed . 21
Figure 4 – Evaluation of SCATTER FRACTION . 25
Figure 5 – Determination of LOR distance from line source . 32
Figure 6 – Cross-section of body phantom . 35
Figure 7 – Phantom insert with hollow spheres . 36
Figure 8 – Image quality phantom and scatter phantom position for whole body scan
acquisition . 38
Figure 9 – Placement of ROIs in the phantom background . 41

– 4 – IEC 61675-1:2022 RLV © IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
RADIONUCLIDE IMAGING DEVICES –
CHARACTERISTICS AND TEST CONDITIONS –

Part 1: Positron emission tomographs

FOREWORD
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...

IEC 61675-1 ®
Edition 3.0 2022-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Radionuclide imaging devices – Characteristics and test conditions –
Part 1: Positron emission tomographs

Dispositifs d'imagerie par radionucléides – Caractéristiques et conditions
d'essai –
Partie 1: Tomographes à émission de positrons

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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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
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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
and French, with equivalent terms in 19 additional languages.
once a month by email.
Also known as the International Electrotechnical Vocabulary

(IEV) online.
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If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer Service
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IEC 61675-1 ®
Edition 3.0 2022-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Radionuclide imaging devices – Characteristics and test conditions –

Part 1: Positron emission tomographs

Dispositifs d'imagerie par radionucléides – Caractéristiques et conditions

d'essai –
Partie 1: Tomographes à émission de positrons

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-1089-5

– 2 – IEC 61675-1:2022 © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Test methods . 13
4.1 General . 13
4.2 SPATIAL RESOLUTION . 13
4.2.1 General . 13
4.2.2 Purpose . 14
4.2.3 Method . 14
4.2.4 Analysis . 15
4.2.5 Report . 17
4.3 Tomographic sensitivity . 18
4.3.1 General . 18
4.3.2 Purpose . 18
4.3.3 Method . 18
4.3.4 Analysis . 20
4.3.5 Report . 20
4.4 Scatter measurement . 20
4.4.1 General . 20
4.4.2 Purpose . 20
4.4.3 Method . 20
4.4.4 Analysis . 21
4.4.5 Report . 23
4.5 PET COUNT RATE PERFORMANCE . 23
4.5.1 General . 23
4.5.2 Purpose . 23
4.5.3 Method . 23
4.5.4 Analysis . 24
4.5.5 Report . 26
4.6 Time-of-flight resolution . 26
4.6.1 General . 26
4.6.2 Purpose . 27
4.6.3 Method . 27
4.6.4 Radionuclide, source distribution and data collection . 27
4.6.5 Data processing . 27
4.6.6 Analysis . 28
4.6.7 Scatter and random removal . 29
4.6.8 FWHM analysis. 29
4.6.9 Report . 29
4.7 Image quality and quantification accuracy of source ACTIVITY concentrations
and PET/CT registration accuracy . 30
4.7.1 General . 30
4.7.2 Purpose . 30
4.7.3 Method . 30

4.7.4 Data analysis . 35
4.7.5 Report . 38
5 ACCOMPANYING DOCUMENTS . 39
5.1 General . 39
5.2 Design parameters and configuration . 39
5.3 SPATIAL RESOLUTION . 40
5.4 Sensitivity . 40
5.5 SCATTER FRACTION . 40
5.6 COUNT RATE performance . 40
5.7 TIME-OF-FLIGHT resolution . 40
5.8 Image quality and quantification accuracy of source ACTIVITY concentrations . 40
Bibliography . 41
Index of defined terms . 42

Figure 1 – Evaluation of FWHM . 16
Figure 2 – Evaluation of EQUIVALENT WIDTH (EW) . 17
Figure 3 – Scatter phantom configuration and position on the imaging bed . 19
Figure 4 – Evaluation of SCATTER FRACTION . 22
Figure 5 – Determination of LOR distance from line source . 27
Figure 6 – Cross-section of body phantom . 31
Figure 7 – Phantom insert with hollow spheres . 32
Figure 8 – Image quality phantom and scatter phantom position for whole body scan
acquisition . 33
Figure 9 – Placement of ROIs in the phantom background . 36

– 4 – IEC 61675-1:2022 © IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
RADIONUCLIDE IMAGING DEVICES –
CHARACTERISTICS AND TEST CONDITIONS –

Part 1: Positron emission tomographs
...