EN IEC 63073-1:2020

SLOVENSKI STANDARD
01-februar-2021
Namenske naprave za slikanje z radionuklidi - Karakteristike in preskusni pogoji -
1. del: Preiskava srca SPECT (IEC 63073-1:2020)
Dedicated Radionuclide Imaging Devices - Characteristics and Test Conditions - Part 1:
Cardiac SPECT (IEC 63073-1:2020)
Spezielle Radionuklid-Bildgebungsgeräte - Merkmale und Prüfbedingungen - Teil 1:
Kardiale SPECT (IEC 63073-1:2020)
Dispositifs d'imagerie par radionucléides dédiés - Caractéristiques et conditions d'essai -
Partie 1: SPECT pour scintigraphie cardiaque (IEC 63073-1:2020)
Ta slovenski standard je istoveten z: EN IEC 63073-1:2020
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 63073-1

NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2020
ICS 11.040.50
English Version
Dedicated radionuclide imaging devices - Characteristics and
test conditions - Part 1: Cardiac SPECT
(IEC 63073-1:2020)
Dispositifs d'imagerie par radionucléides dédiés - Spezielle Radionuklid-Bildgebungsgeräte - Merkmale und
Caractéristiques et conditions d'essai - Partie 1: SPECT Prüfbedingungen - Teil 1: Kardiale SPECT
pour scintigraphie cardiaque (IEC 63073-1:2020)
(IEC 63073-1:2020)
This European Standard was approved by CENELEC on 2020-11-30. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 63073-1:2020 E

European foreword
The text of document 62C/740/CDV, future edition 1 of IEC 63073-1, prepared by SC 62C "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-08-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-11-30
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 63073-1:2020 was approved by CENELEC as a European
Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
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.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 61675-2 2015 Radionuclide imaging devices - EN 61675-2 2015
Characteristics and test conditions - Part 2:
Gamma cameras for planar, wholebody,
and SPECT imaging
IEC 63073-1 ®
Edition 1.0 2020-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Dedicated radionuclide imaging devices – Characteristics and test conditions –

Part 1: Cardiac SPECT
Dispositifs d'imagerie par radionucléides dédiés – Caractéristiques et

conditions d'essai –
Partie 1: SPECT pour scintigraphie cardiaque

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-8967-9

– 2 – IEC 63073-1:2020 © IEC 2020
CONTENTS
CONTENTS . 2
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Test methods . 7
4.1 General . 7
4.2 Detector characteristics . 8
4.2.1 General . 8
4.2.2 Energy resolution and LOW-ENERGY-TAIL RATIO measurement . 8
4.2.3 Shield leakage . 9
4.2.4 COUNT RATE performance . 10
4.2.5 System sensitivity . 12
4.2.6 Non-uniformity for each CARDIAC DETECTOR HEAD . 14
4.2.7 SCATTER FRACTION . 14
4.3 Characteristics of tomographic images . 16
4.3.1 CENTRE OF ROTATION (COR) . 16
4.3.2 REFERENCE POINT localization in the reconstructed FOV . 16
4.3.3 Accuracy of tomographic system sensitivity modelling . 17
4.3.4 Tomographic SPATIAL NON-LINEARITY. 19
4.3.5 Tomographic SPATIAL RESOLUTION . 21
4.3.6 Image quality assessment using a heart phantom . 23
5 Additional testing . 26
6 ACCOMPANYING DOCUMENTS . 27
Bibliography . 28
Index of defined terms . 29

Figure 1 – Small shielded liquid source . 10
Figure 2 – Transverse slice of phantom used for measuring COUNT RATE performance . 11
Figure 3 – Evaluation of SCATTER FRACTION . 15
Figure 4 – Calculation of FWHM and measurement of the location of the maximum
value. 17
Figure 5 – Transaxial view of the 7 LINE SOURCE Phantom . 18
Figure 6 – Transaxial view of the 7 LINE SOURCE phantom centred within a 140 mm
diameter water-filled cylinder . 22
Figure 7 – Placement of ROIs in SHORT AXIS view of myocardium . 25
Figure 8 – Placement of ROIs in LONG AXIS view of myocardium . 26

Table 1 – Relative ACTIVITY concentration of compartments of the anthropomorphic
phantom . 24

IEC 63073-1:2020 © IEC 2020 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
DEDICATED RADIONUCLIDE IMAGING DEVICES –
CHARACTERISTICS AND TEST CONDITIONS –

Part 1: Cardiac SPECT
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.
International Standard IEC 63073-1 has been prepared by subcommittee 62C: Equipment for
radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
The text of this document is based on the following documents:
CDV Report on voting
62C/740/CDV 62C/765/RVC
Full information on the voting for the approval of this document can be found in the report on
voting indicated in the above tab
...