IEC TR 61948-3:2018

Nuclear medicine instrumentation - Routine tests - Part 3: Positron emission tomographs

IEC TR 61948-3:2018(E) 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 these routine tests are compared to the reference data determined during or after 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.
quality control tests specific to only the CT component of the PET/CT are described in 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.
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,
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.

General Information

• Status: Published
• Publication Date: 09-Jan-2018
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• 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: 25-Jan-2018
• Completion Date: 10-Jan-2018

Relations

• Revises: IEC TR 61948-3:2005 - Nuclear medicine instrumentation - Routine tests - Part 3: Positron emission tomographs
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC TR 61948-3 ®
Edition 2.0 2018-01
TECHNICAL
REPORT
Nuclear medicine instrumentation – Routine tests –
Part 3: Positron emission tomographs
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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
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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

– 6 – IEC TR 61948-3:2018 © IEC 2018
3.1
acceptance test
test carried out after new equipment has been installed, or major modifications have been
made to existing equipment, in order to verify compliance with contractual specifications
Note 1 to entry: During or immediately after ACCEPTANCE TEST, REFERENCE DATA are collected to be used as a
standard for comparison with future ROUTINE TESTS.
[SOURCE: IEC TR 60788:2004, rm-70-01, modified – Addition of a Note to entry.]
3.2
annihilation radiation
ionizing radiation that is produced when a particle and its antiparticle interact and cease to
exist
[SOURCE: IEC 61675-1:2013, 3.1.3.2]
3.3
calibration factor
relation between measured COUNT RATE per reconstructed unit volume and the true ACTIVITY
concentration in the object
Note 1 to entry: Although the CALIBRATION FACTOR depends on the acquisition configuration affecting the
sensitivity of the system (e.g. 2D, 3D), it is independent of the actual acquisition parameters (e.g. acquisition time,
ACTIVITY injected, etc.).
3.4
count loss
difference between measured COUNT RATE and true COUNT RATE, which is caused by the finite
RESOLVING TIME of the instrument
[SOURCE: IEC 61675-1:2013, 3.8.1]
3.5
count rate
number of counts per unit of time
[SOURCE: IEC 61675-1:2013, 3.8.2]
3.6
line of response
LOR
axis of the PROJECTION BEAM
Note 1 to entry: In PET, it is the line connecting the centres of two opposing detector elements operated in
...