EN 61675-2:2015

Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar, wholebody, and SPECT imaging

IEC 61675-2:2015 specifies terminology and test methods for describing the characteristics of gamma cameras equipped with parallel hole collimators for planar imaging. This second edition of IEC 61675-2 cancels and replaces the first edition published in 1998 and its Amendment 1 published in 2004, as well as IEC 60789:2005, IEC 60789:2005/COR1:2009, and IEC 61675-3:1998. It has been reformatted, updated, and partly aligned with NEMA NU 1-2007.

Bildgebende Systeme in der Nuklearmedizin - Merkmale und Prüfbedingungen - Teil 2: Gammakameras für planare Bildgebung, mit Ganzkörper-Zusatz und Gammakameras zur Einzelphotonen-Emissions-Tomographie (SPECT)

Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie 2: Gamma-caméras pour l'imagerie planaire, l'imagerie du corps entier et l'imagerie SPECT

L'IEC 61675-2:2015 spécifie la terminologie et les méthodes d'essai relatives à la description des caractéristiques des gamma-caméras équipées de collimateurs à trous parallèles pour l'imagerie planaire. Cette seconde édition de l'IEC 61675-2 annule et remplace la première édition publiée en 1998 et son Amendement 1 publié en 2004, ainsi que l'IEC 60789:2005, l'IEC 60789:2005/COR1:2009, et l'IEC 61675-3:1998. Elle a fait l'objet d'un reformatage, d'une mise à jour et d'un alignement partiel avec le document NEMA NU 1-2007.

Naprave za opazovanje radioaktivnih elementov - Karakteristike in preskusni pogoji - 2. del: Gama kamere za planarno slikanje in slikanje SPECT (IEC 61675-2:2015)

Ta del standarda IEC 61675 določa terminologijo in preskusne metode za opisovanje karakteristik GAMA KAMER, opremljenih s KOLIMATORJI Z VZPOREDNIMI LUKNJAMI za planarno slikanje. Dodatni preskusi so določeni za GAMA KAMERE, ki so zmožne planarnega slikanja celega telesa (OPREMA ZA PLANARNO SLIKANJE CELEGA TELESA) ali ENOFOTONSKE IZSEVNE RAČUNALNIŠKE TOMOGRAFIJE (SPECT). Te GAMA KAMERE so sestavljene iz podstavka, ene ali več GLAV DETEKTORJA in računalnika za pridobivanje, obdelavo, shranjevanje in prikaz podatkov. GLAVE DETEKTORJA lahko vsebujejo enega ali več kristalov za iskrenje ali detektorje v trdnem stanju. Za označevanje enotnosti rekonstruiranih slik ni bil določen noben preskus, ker vse do zdaj znane metode v večini primerov izražajo šum slik.

General Information

• Status: Published
• Publication Date: 05-Nov-2015
• Withdrawal Date: 09-Sep-2018
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 06-Nov-2015
• Completion Date: 06-Nov-2015
• Ref Project: SIST EN 61675-2:2016 - Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar imaging and spect imaging (IEC 61675-2:2015)

Relations

• Replaces: EN 61675-2:1998 - Radionuclide imaging devices - Characteristics and test conditions - Part 2: Single photon emission computer tomographs
• Effective Date: 25-Jan-2023
• Replaces: EN 60789:2005 - Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras
• Effective Date: 10-Nov-2015
• Replaces: EN 61675-3:1998 - Radionuclide imaging devices - Characteristics and test conditions - Part 3: Gamma camera based wholebody imaging systems
• Effective Date: 10-Nov-2015
• Replaces: EN 61675-2:1998/A1:2005 - Radionuclide imaging devices - Characteristics and test conditions - Part 2: Single photon emission computer tomographs
• Effective Date: 16-Jul-2014
• Revised: prEN IEC 61675-2:2024 - Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar, wholebody, and SPECT imaging
• Effective Date: 23-May-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2016
1DGRPHãþD
SIST EN 60789:2007
SIST EN 61675-2:1998
SIST EN 61675-2:1998/A1:2005
SIST EN 61675-3:1998
Naprave za opazovanje radioaktivnih elementov - Karakteristike in preskusni
pogoji - 2. del: Gama kamere za planarno slikanje in slikanje SPECT (IEC 61675-
2:2015)
Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma
cameras for planar imaging and spect imaging (IEC 61675-2:2015)
Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie
2: gamma caméras pour l'imagerie planaire et l'imagerie spect
Ta slovenski standard je istoveten z: EN 61675-2:2015
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 61675-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2015
ICS 11.040.50 Supersedes EN 60789:2005, EN 61675-2:1998, EN
61675-3:1998
English Version
Radionuclide imaging devices - Characteristics and test
conditions - Part 2: Gamma cameras for planar, wholebody, and
SPECT imaging
(IEC 61675-2:2015)
Dispositifs d'imagerie par radionucléides - Caractéristiques Bildgebende Systeme in der Nuklearmedizin - Merkmale
et conditions d'essai - Partie 2: Gamma-caméras pour und Prüfbedingungen - Teil 2: Gammakameras für planare
l'imagerie planaire, l'imagerie du corps entier et l'imagerie Bildgebung, mit Ganzkörper-Zusatz und Gammakameras
SPECT zur Einzelphotonen-Emissions-Tomographie (SPECT)
(IEC 61675-2:2015) (IEC 61675-2:2015)
This European Standard was approved by CENELEC on 2015-09-10. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 61675-2:2015 E
European foreword
The text of document 62C/616/FDIS, future edition 2 of IEC 61675-2, prepared by IEC/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 61675-2:2015.
The following dates are fixed:
(dop) 2016-06-10
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-09-10
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This document supersedes EN 61675-2:1998 and A1:2005, EN 60789:2005 and EN 61675-3:1998.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
Endorsement notice
The text of the International Standard IEC 61675-2:2015 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-1:2005 NOTE  Harmonized as EN 60601-1:2006 (not modified).
A1:2012 A1:2013
IEC 61675-1:2013 NOTE  Harmonized as EN 61675-1:2014 (not modified).
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When 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/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61675-1 2013 Radionuclide imaging devices - EN 61675-1 2014
Characteristics and test conditions -- Part
1: Positron emission tomographs

IEC 61675-2 ®
Edition 2.0 2015-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Radionuclide imaging devices – Characteristics and test conditions –

Part 2: Gamma cameras for planar, wholebody, and SPECT imaging

Dispositifs d’imagerie par radionucléides – Caractéristiques et conditions

d’essai –
Partie 2: Gamma-caméras pour l'imagerie planaire, l'imagerie du corps entier et

l'imagerie SPECT
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-2819-7

– 2 – IEC 61675-2:2015 © IEC 2015
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions. 7
4 Test methods . 15
4.1 General . 15
4.2 Planar imaging . 16
4.2.1 SYSTEM SENSITIVITY . 16
4.2.2 SPATIAL RESOLUTION . 18
4.2.3 SPATIAL NON-LINEARITY. 24
4.2.4 NON-UNIFORMITY OF RESPONSE . 25
4.2.5 INTRINSIC ENERGY RESOLUTION . 28
4.2.6 Intrinsic MULTIPLE WINDOW SPATIAL REGISTRATION . 29
4.2.7 COUNT RATE performance . 31
4.2.8 Shield leakage test . 33
4.3 Wholebody imaging . 33
4.3.1 Scanning constancy . 33
4.3.2 SPATIAL RESOLUTION without scatter . 36
4.4 Tomographic imaging (SPECT) . 37
4.4.1 Test of PROJECTION geometry . 37
4.4.2 Measurement of SPECT SYSTEM SENSITIVITY . 41
4.4.3 Scatter measurement . 44
4.4.4 SPECT SYSTEM SPATIAL RESOLUTION . 48
4.4.5 Tomographic image quality . 50
5 Accompanying documents . 57
5.1 General . 57
5.2 General parameters for GAMMA CAMERAS . 58
5.2.1 COLLIMATORS . 58
5.2.2 Shield leakage values . 58
5.2.3 Pre-set PULSE AMPLITUDE ANALYSER WINDOWS . 58
5.2.4 INTRINSIC ENERGY RESOLUTION . 58
5.2.5 COLLIMATOR dependent quantities . 58
5.2.6 COUNT RATE CHARACTERISTICS . 58
5.2.7 Measured COUNT RATE that is 80 % of the corresponding TRUE COUNT
RATE . 58
5.2.8 Dimensions of the DETECTOR FIELD OF VIEW . 58
5.2.9 Non-uniformity characteristics . 58
5.2.10 INTRINSIC SPATIAL RESOLUTION (FWHM and EW) of the DETECTOR HEAD
COLLIMATOR . 58
without
5.2.11 INTRINSIC SPATIAL NON-LINEARITY . 58
5.2.12 Intrinsic MULTIPLE WINDOW SPATIAL REGISTRATION . 59
5.3 GAMMA CAMERA based wholebody imaging system . 59
5.3.1 Scanning constancy . 59
5.3.2 SPATIAL RESOLUTION . 59
5.4 SPECT . 59

IEC 61675-2:2015 © IEC 2015 – 3 –
5.4.1 Calibration measurements of COR . 59
5.4.2 Measurement of head tilt . 59
5.4.3 Measurement of COLLIMATOR hole misalignment . 59
5.4.4 TRANSVERSE RESOLUTION (radial and tangential) . 59
5.4.5 AXIAL RESOLUTION . 59
5.4.6 Axial PIXEL size . 59
5.4.7 Transaxial PIXEL size . 59
5.4.8 DETECTOR POSITIONING TIME . 59
5.4.9 NORMALIZED VOLUME SENSITIVITY . 59
5.4.10 SCATTER FRACTIONS SF and SF . 59
i
5.4.11 Scan set up and phantom ACTIVITY concentration . 59
5.4.12 Image quality . 59
5.4.13 Accuracy of ATTENUATION correction and scatter correction . 59
5.4.14 Accuracy of SPECT and CT image registration . 59
Index of defined terms . 60
Bibliography . 62

Figure 1 – Geometry of PROJECTIONS . 9
Figure 2 – Cylindrical phantom . 14
Figure 3 – Cuvette . 17
Figure 4 – Slit phantom . 19
Figure 5 – Source arrangement for intrinsic measurements .
...