SIST EN IEC 63073-1:2021

SLOVENSKI STANDARD
SIST EN IEC 63073-1:2021
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
SIST EN IEC 63073-1:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 63073-1:2021

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SIST EN IEC 63073-1:2021


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

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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
EN IEC 63073-1:2020.
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.
2

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EN IEC 63073-1:2020 (E)
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

3

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SIST EN IEC 63073-1:2021




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




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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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

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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 table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

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In this document, the following print types are used:
– terms defined in Clause 3 of this document or listed in the index of defined terms:
SMALL CAPITALS.
The requirements are followed by specifications for the relevant tests.
A list of all parts in the IEC 63073 series, published under the general title Dedicated
radionuclide imaging devices – Characteristics and test condtions, can be found on the IEC
website.
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.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates that it
contains colours which are considered to be useful for the correct understanding of its
contents. Users should therefore print this document using a colour printer.

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IEC 63073-1:2020 © IEC 2020 – 5 –
INTRODUCTION
The test methods specified in this part of IEC 63073 have been selected to reflect as much as
possible the clinical use of GAMMA CAMERAS that are dedicated to cardiac SINGLE PHOTON
EMISSION COMPUTED TOMOGRAPHY (SPECT). It is intended that the test methods are carried out
by manufacturers thereby enabling them to describe the characteristics of the systems on a
common basis.

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DEDICATED RADIONUCLIDE IMAGING DEVICES –
CHARACTERISTICS AND TEST CONDITIONS –

Part 1: Cardiac SPECT



1 Scope
This document specifies terminology and test methods for describing the characteristics of
SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) systems designed specifically for
tomographic cardiac imaging. This includes dedicated systems or general purpose systems with
dedicated sub-systems which are not included in the scope of IEC 61675-2.
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 61675-2:2015, Radionuclide imaging devices – Characteristics and test conditions – Part 2:
Gamma cameras for planar, wholebody, and SPECT imaging
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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
3.1
REFERENCE POINT
defined 3D position in the FOV of the camera, specified by the manufacturer, or, if not specified
by the manufacturer, assumed to be the centre of the FOV of the camera
3.2
BAD PIXEL
detector pixel that has been physically or electronically turned off such that gamma rays which
interact in that BAD PIXEL are not recorded by the camera
3.3
CARDIAC DETECTOR HEAD
assembly of detector components associated with a single COLLIMATOR
3.4
CARDIAC DETECTOR HEAD ELEMENT
smallest discrete unit of the CARDIAC DETECTOR HEAD that is able to provide distinct energy,
spatial, and timing information about detected photons

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3.5
CCFOV
central volume of the field of view of a cardiac camera, located within a radius of 7 cm from the
REFERENCE POINT
3.6
CUFOV
field of view of a cardiac camera for which the summed counts for a LINE SOURCE segment are
at least 50 % of the summed counts measured with the camera with the LINE SOURCE segment
positioned within the CCFOV
3.7
CARDIAC ORIENTATION
image coordinate system specified in reference to the axes of the heart
3.8
SHORT AXIS
SA
in the CARDIAC ORIENTATION, the plane perpendicular to the long-axis of the heart
3.9
LONG AXIS
LA
in the CARDIAC ORIENTATION, a plane parallel to the long-axis of the heart
3.10
HORIZONTAL LONG AXIS
HLA
in the CARDIAC ORIENTATION, the LONG AXIS plane that most closely bisects both the left ventricle
and the right ventricle of the heart
3.11
VERTICAL LONG AXIS
VLA
in the CARDIAC ORIENTATION, the LONG AXIS plane, that is perpendicular to the HORIZONTAL LONG
AXIS
3.12
LOW-ENERGY-TAIL RATIO
ratio of the counts measured in an ENERGY WINDOW Of width 2 × E centred at energy E
FWHM peak
– 2 × E divided by the counts measured in an ENERGY WINDOW Of width 2 × E centred
FWHM FWHM
at an energy of E , where E is the peak energy of the radioisotope being measured and
peak peak
E is the energy resolution of the detector
FWHM
4 Test methods
4.1 General
Before the measurements are performed, the tomographic system shall be adjusted by the
procedure normally used by the manufacturer for an installed unit and shall not be adjusted
specially for the measurement of specific parameters. If any test cannot be carried out exactly
as specified in the standard, the reason for the deviation and the exact conditions under which
the test was performed shall be stated clearly.
Unless otherwise specified, each CARDIAC DETECTOR HEAD in the system shall be characterized
by a full data set.

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Unless otherwise specified, SPECT characterization shall be provided for an acquisition
covering the minimal rotation required to obtain a complete set of data (e.g. 120° for a three-
headed rotating-gantry system). If a rotating-gantry tomograph is specified to operate in a non-
circular orbiting mode influencing the performance parameters, test results for the non-circular
orbiting mode shall be reported in addition.
Unless otherwise specified, measurements are carried out at COUNT RATES not exceeding
40 000 counts per second on each CARDIAC DETECTOR HEAD and not exceeding 120 000 counts
per second for the system.
4.2 Detector characteristics
4.2.1 General
Evaluation of detector characteristics for cardiac systems are performed extrinsically (with
COLLIMATORS in place). Additionally, for systems that allow the removal of the COLLIMATOR,
intrinsic detector characteristics shall be specified and tested in accordance with IEC 61675-2.
4.2.2 Energy resolution and LOW-ENERGY-TAIL RATIO measurement
4.2.2.1 General
Energy resolution describes the ability of the detector to properly identify the energy of the
detected photons. Due to incomplete charge collection, the detector material in some cardiac
systems may have an increased fraction of photons detected with reduced energy. The effect
is characterized by measuring the LOW-ENERGY-TAIL RATIO.
An energy spectrum is determined for each CARDIAC DETECTOR HEAD.
4.2.2.2 Purpose
The energy resolution is measured to characterize the ability of a GAMMA CAMERA to separate
photons with different energies.
4.2.2.3 Method
Measure an energy spectrum in low scatter configuration using an irradiation of the entire
CARDIAC DETECTOR HEAD. This measurement is performed separately for each CARDIAC DETECTOR
HEAD.
4.2.2.4 RADIONUCLIDE
99m 57
The sources are Tc and Co.
4.2.2.5 RADIOACTIVE SOURCE DISTRIBUTION
A LINE SOURCE with internal diameter of < 1,2 mm is placed so as to illuminate the entire CARDIAC
DETECTOR HEAD. The COUNT RATE shall not exceed 40 000 counts per second.
4.2.2.6 Data collection
For each CARDIAC DETECTOR HEAD, the pulse height spectrum is obtained with a channel width
less than or equal to 5 % of the expected photopeak FWHM. The number of counts in the peak
channel is greater than 10 000. The spectrum is obtained over the entire usable energy range
of the detector.

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4.2.2.7 Data processing
For the energy spectrum, the channel numbers are expressed in terms of energy by scaling the
channel number by the difference in peak energies of the two RADIONUCLIDES divided by the
difference in their measured peak channel positions.
4.2.2.8 Data analysis
For each CARDIAC DETECTOR HEAD, the energy resolution, E , is the FWHM of the full energy
FWHM
absorption peak with a peak energy, E , closest to the expected photopeak energy.
peak
For each CARDIAC DETECTOR HEAD, the LOW-ENERGY-TAIL RATIO, Q , is defined as:

tail
Q = Z / Z (1)
tail tail peak
where
Z is the sum of counts from the averaged energy spectrum in the ENERGY WINDOW
peak
centred on the energy peak E with the width of 2 × E ;
peak FWHM
Z is the sum of counts from the averaged energy spectrum in the ENERGY WINDOW
tail
centred on the energy E – 2 × E with the width of 2 × E .
peak FWHM FWHM
4.2.2.9 Report
The energy resolution, expressed as a percentage of the peak energy, and the LOW-ENERGY-
TAIL RATIO are reported for each CARDIAC DETECTOR HEAD. The mean and standard deviation of
the energy resolution and LOW-ENERGY-TAIL RATIO for the entire system is also reported if the
system has more than 5 CARDIAC DETECTOR HEADS.
4.2.3 Shield leakage
4.2.3.1 General
The DETECTOR SHIELD prevents the detection of unwanted photons originated from outside the
entrance field of view of the COLLIMATOR.
4.2.3.2 Purpose
The purpose of this test is to identify the locations of the highest leakage and its magnitude.
4.2.3.3 Method
The complete surface of cardiac camera system is swept with a collimated source searching for
the maximum leakage COUNT RATES at the rear and the side of the DETECTOR SHIELD and the
joints (particularly the joint between the COLLIMATOR And the DETECTOR SHIELD), if it is
accessible.
4.2.3.4 RADIONUCLIDE
99m
The source is Tc.
4.2.3.5 RADIOACTIVE SOURCE DISTRIBUTION
A small collimated source, as illustrated in Figure 1, with d not larger than 20 mm and t not less
than 10 mm, totally filled with the RADIONUCLIDE

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4.2.3.6 Data collection
The source is placed in contact with the external surface of the DETECTOR SHIELD and the joints
if accessible. The entire surface of the DETECTOR SHIELD is swept and the system COUNT RATES
measured during a clinical acquisition mode. For systems with a rotating gantry, the data
collection is performed at a single gantry angle.
4.2.3.7 Data processing
The maximum leakage COUNT RATES at the rear and the side of the DETECTOR SHIELD, normalized
to the source ACTIVITY, are recorded. Also the maximum leakage COUNT RATE at joints in the
shield, normalized to the source ACTIVITY, is recorded.
4.2.3.8 Data analysis
The normalized leakage COUNT RATES are divided by the sensitivity of the system as measured
in 4.2.5.
4.2.3.9 Report
The three normalized maximum leakage COUNT RATES expressed as a percentage of the
sensitivity measured in 4.2.5, and the locations at which they were measured, are reported.
Dimensions in millimetres

Figure 1 – Small shielded liquid source
NOTE See 4.2.3.5 for recommended values for d and t.
4.2.4 COUNT RATE performance
4.2.4.1 General
COUNT RATE performance depends in a complex manner on the spatial distribution of ACTIVITY
and scattering materials, which therefore should simulate clinical imaging situations. Therefore
the tests are conducted with COLLIMATOR and scattering material.

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COUNT RATE performance measures the relationship between the registered COUNT RATE and
ACTIVITY, i.e. the COUNT RATE CHARACTERISTIC. The COUNT RATE CHARACTERISTIC describes the
constancy of the GAMMA CAMERA sensitivity at different ACTIVITY levels and is highly dependent
on the set-up of the measurement conditions.
4.2.4.2 Purpose
The procedure described here is designed to evaluate deviations from the linear relationship
between COUNT RATE and ACTIVITY, caused by COUNT LOSSES, over a clinically relevant range of
COUNT RATES.
4.2.4.3 Method
Measurements of the COUNT RATE are performed at various ACTIVITY levels. The variation of
ACTIVITY is normally achieved by RADIOACTIVE decay. No correction is made for COUNT LOSSES
and scatter. Each measured count is taken into account only once.
4.2.4.4 RADIONUCLIDE
99m
The RADIONUCLIDE for the measurement is Tc with ENERGY WINDOW Of 140 keV ± 10 %.
4.2.4.5 RADIOACTIVE SOURCE distribution
A cylindrical phantom (Figure 2) with a LINE SOURCE insert is used. The phantom is filled with
non-radioactive water as a scatter medium. The LINE SOURCE of at least 7 cm in length is
inserted and positioned on the central axis of the cylinder. The LINE SOURCE is centred on the
REFERENCE POINT of the system and aligned with the patient inferior-superior axis.
Dimensions in millimetres

Figure 2 – Transverse slice of phantom used for measuring COUNT RATE performance
4.2.4.6 Data collection
A COUNT RATE CHARACTERISTIC (measured COUNT RATE versus incident COUNT RATE or ACTIVITY)
is to be measured by acquiring a series of images over time (e.g. frames). The variation of
ACTIVITY is accomplished by RADIOACTIVE decay with measurements continuing over
approximately 10 RADIOACTIVE HALF-LIVES. The time per frame is less than one-half of the

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RADIOACTIVE HALF-LIFE with the exception of the last three frames, which can be longer. The
initial amount of ACTIVITY is chosen to be 2 GBq ± 10 %.
A background acquisition is performed.
4.2.4.7 Data processing
The total counts acquired in each image is processed. Background correction is performed for
all frames.
The average of the decaying ACTIVITY, A , during the data acquisition interval for time frame i,
ave,i
T , is determined by the following equation:
acq,i
T
T −T  
1 T
cal 0,i acq,i
12/
exp ln2 1 exp ln2 (2)
AA −−
 
ave,i cal 
 
ln2 TT T
acq,i 1/ 2 1/ 2
 

where
A is the ACTIVITY Measured at time T ;
cal cal
T is the acquisition start-time of the time frame i;
0,i
T is the RADIOACTIVE HALF-LIFE of the RADIONUCLIDE in use.
1/2
From the above measurements, plot the COUNT RATE CHARACTERISTIC (i.e. measured COUNT RATE
versus ACTIVITY).
The conversion factor
...