IEC TR 61948-3:2018

IEC TR 61948-3 ®
Edition 2.0 2018-01
TECHNICAL
REPORT
Nuclear medicine instrumentation – Routine tests –
Part 3: 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
your local IEC member National Committee for further information.

IEC Central Office 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 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 21 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

IEC publications search - webstore.iec.ch/advsearchform IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 67 000 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and withdrawn publications.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: sales@iec.ch.
IEC TR 61948-3 ®
Edition 2.0 2018-01
TECHNICAL
REPORT
Nuclear medicine instrumentation – Routine tests –

Part 3: Positron emission tomographs

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-5230-7

– 2 – IEC TR 61948-3:2018 © IEC 2018
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Test methods . 8
4.1 RELATIVE SENSITIVITY PER LINE OF RESPONSE and accuracy of NORMALIZATION . 8
4.2 CALIBRATION FACTOR and cross-calibration . 8
4.3 TRANSVERSE RESOLUTION . 9
4.4 Image quality . 9
4.5 PET/CT co-registration . 9
5 Frequency of ROUTINE TESTS . 9
Bibliography . 10
Index of defined terms . 11

Table 1 – Frequency of ROUTINE TESTS . 9

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
NUCLEAR MEDICINE INSTRUMENTATION –
ROUTINE TESTS –
Part 3: Positron emission tomographs

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 Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC TR 61948-3, which is a technical report, has been prepared by subcommittee 62C:
Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical
committee 62: Electrical equipment in medical practice.
This second edition cancels and replaces the first edition published in 2005. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) a clause to check routine performance tests has been added,

– 4 – IEC TR 61948-3:2018 © IEC 2018
b) a test to check the accuracy of co-registration of PET and CT images has been added,
c) a test to check image quality has been added,
d) the test to check pixel size has been removed.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62C/694/DTR 62C/708/RVDTR
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
A list of all parts in the IEC 61948 series, published under the general title Nuclear medicine
Instrumentation – Routine tests, can be found on the IEC website.
Terms used throughout this document that have been defined in Clause 3 appear in SMALL
CAPITALS.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

NUCLEAR MEDICINE INSTRUMENTATION –
ROUTINE TESTS –
Part 3: Positron emission tomographs

1 Scope
This part of IEC 61948 describes test methods for POSITRON EMISSION TOMOGRAPHS (PET). As
part of QUALITY CONTROL, this document is defining ROUTINE TESTS to be performed by the user
of POSITRON EMISSION TOMOGRAPHS to maintain proper operation conditions. The results of
ROUTINE TESTS are compared to the REFERENCE DATA determined during or after
these
ACCEPTANCE TEST. Methods used for ACCEPTANCE TESTS are described in IEC 61675-1:2013.
In addition, today a POSITRON EMISSION TOMOGRAPH often includes X-RAY EQUIPMENT for
COMPUTED TOMOGRAPHY (CT). For this document, PET/CT hybrid devices are considered to be
state of the art, dedicated POSITRON EMISSION TOMOGRAPHS not including the X-ray component
being special cases only.
UALITY CONTROL tests specific to only the CT component of the PET/CT are described in
Q
IEC 61223-2-6. The CT SCANNER also is subject to a TYPE TEST according to IEC 60601-1 and
applicable collateral and particular standards.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their
content constitutes requirements of this document. For dated references, only the edition
cited applies. For undated references, the latest edition of the referenced document (including
any amendments) applies.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 61223-2-6:2006, Evaluation and routine testing in medical imaging departments –
Part 2­6: Constancy tests – Imaging performance of computed tomography X­ray equipment
IEC 61675-1:2013, Radionuclide imaging devices – Characteristics and test conditions –
Part 1: Positron emission tomographs
IEC TR 61948-1:2016, Nuclear medicine instrumentation – Routine tests – Part 1: Gamma
radiation counting systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 61675-1,
IEC TR 61948-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp

-------------
...