EN 61675-1:2014
(Main)Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs
Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs
IEC 61675-1:2013 specifies terminology and test methods for declaring the characteristics of positron emission tomographs. Positron emission tomographs detect the annihilation radiation of positron emitting Radionuclides by coincidence detection. No test has been specified to characterize the uniformity of reconstructed images, because all methods known so far will mostly reflect the noise in the image. This second edition replaces the first edition of IEC 61675-1, published in 1998. This edition constitutes a technical revision. Requirements have been changed regarding the following technical aspects: - spatial resolution; - sensitivity measurement; - scatter fraction; - count rate performance; - and image quality. Keywords: imaging, medical device
Bildgebende Systeme in der Nuklearmedizin - Merkmale und Prüfbedingungen - Teil 1: Positronen-Emissions-Tomographen
Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie 1: Tomographes à émission de positrons
La CEI 61675-1:2013 spécifie la terminologie et les méthodes d'essai relatives à la description des caractéristiques des tomographes à émission de positrons. Les tomographes à émission de positrons détectent le rayonnement d'annihilation des radionucléides émettant des positrons par la détection en coïncidence. Aucun essai n'a été spécifié afin de caractériser l'uniformité des images reconstituées, puisque toutes les méthodes connues jusqu'à présent reflètent principalement le bruit de l'image. Cette deuxième édition remplace la première édition de la IEC 61675-1, parue en 1998. Elle constitue une révision technique. Les exigences concernant les aspects techniques ci-dessous ont été modifiées: - résolution spatiale; - mesure de la sensibilité; - fraction de diffusion; - performance du taux de comptage; - et qualité d'image. Mots clé: imagerie, médicale
Naprave za slikanje z radionuklidi - Karakteristike in preskusni pogoji - 1. del: Pozitronska emisijska tomografija (IEC 61675-1:2013)
Ta del standarda IEC 61675 določa terminologijo in preskusne metode za navedbo lastnosti POZITRONSKE EMISIJSKE TOMOGRAFIJE. POZITRONSKA EMISIJSKA TOMOGRAFIJA zaznava ANIHILACIJSKO SEVANJE RADIONUKLIDOV, ki oddajajo pozitrone, z ZAZNAVANJEM KOINCIDENC. Za označevanje enotnosti rekonstruiranih slik ni bil določen noben preskus, ker vse do zdaj znane metode v večini primerov izražajo šum na sliki.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Naprave za slikanje z radionuklidi - Karakteristike in preskusni pogoji - 1. del: Pozitronska emisijska tomografija (IEC 61675-1:2013)Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie 1: Tomographes à émission de positrons (IEC 61675-1:2013)Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs (IEC 61675-1:2013)11.040.50Radiografska opremaRadiographic equipmentICS:Ta slovenski standard je istoveten z:EN 61675-1:2014SIST EN 61675-1:2016en01-oktober-2016SIST EN 61675-1:2016SLOVENSKI
STANDARDSIST EN 61675-1:1998/A1:2008SIST EN 61675-1:19981DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 61675-1
June 2014 ICS 11.040.50
Supersedes
EN 61675-1:1998
English Version
Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs (IEC 61675-1:2013)
Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie 1: Tomographes à émission de positrons (CEI 61675-1:2013)
Bildgebende Systeme in der Nuklearmedizin - Merkmale und Prüfbedingungen - Teil 1: Positronen-Emissions-Tomographen (IEC 61675-1:2013) This European Standard was approved by CENELEC on 2013-10-30. 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, 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 © 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 61675-1:2014 E SIST EN 61675-1:2016
Foreword The text of document 62C/550/CDV, future edition 2 of IEC 61675-1, 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 61675-1:2014. The following dates are fixed: • latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2014-12-13 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2016-10-30
This document supersedes EN 61675-1:1998. 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 61675-1:2013 was approved by CENELEC as a European Standard without any modification. SIST EN 61675-1:2016
- 3 - EN 61675-1:2014 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
When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies.
Publication Year Title EN/HD Year
IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - -
IEC 61675-1 Edition 2.0 2013-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Radionuclide imaging devices – Characteristics and test conditions –
Part 1: Positron emission tomographs
Dispositifs d'imagerie par radionucléides – Caractéristiques et conditions d'essai –
Partie 1: Tomographes à émission de positrons
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE W ICS 11.040.50 PRICE CODE CODE PRIX ISBN 978-2-8322-1119-9
– 2 – 61675-1 © IEC:2013 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 Scope . 7 2 Normative references . 7 3 Terms and definitions . 7 4 Test methods . 13 4.1 General . 13 4.2 SPATIAL RESOLUTION . 13 4.2.1 General . 13 4.2.3 Method . 14 4.2.4 Analysis . 15 4.2.5 Report . 17 4.3 Tomographic sensitivity. 18 4.3.1 General . 18 4.3.2 Purpose . 18 4.3.3 Method . 18 4.3.4 Analysis . 19 4.3.5 Report . 20 4.4 Uniformity . 20 4.5 Scatter measurement . 20 4.5.1 General . 20 4.5.2 Purpose . 20 4.5.3 Method . 20 4.5.4 Analysis . 21 4.5.5 Report . 22 4.6 PET COUNT RATE PERFORMANCE . 23 4.6.1 General . 23 4.6.2 Purpose . 23 4.6.3 Method . 23 4.6.4 Analysis . 24 4.6.5 Report . 26 4.7 Image quality and quantification accuracy of source ACTIVITY concentrations . 26 4.7.1 General . 26 4.7.2 Purpose . 26 4.7.3 Method . 27 4.7.4 Data analysis . 31 4.7.5 Report . 34 5 ACCOMPANYING DOCUMENTS . 35 5.1 General . 35 5.2 Design parameters . 35 5.3 Configuration of the tomograph . 36 5.4 SPATIAL RESOLUTION . 36 5.5 Sensitivity . 36 5.6 SCATTER FRACTION . 36 5.7 COUNT RATE performance . 36 SIST EN 61675-1:2016
61675-1 © IEC:2013 – 3 – 5.8 Image quality and quantification accuracy of source ACTIVITY concentrations . 36 Bibliography . 37 Index of defined terms . 38
Figure 1 – Evaluation of FWHM . 16 Figure 2 – Evaluation of EQUIVALENT WIDTH (EW) . 17 Figure 3 – Scatter phantom configuration and position on the imaging bed . 19 Figure 4 – Evaluation of SCATTER FRACTION . 22 Figure 5 – Cross-section of body phantom . 27 Figure 6 – Phantom insert with hollow spheres . 28 Figure 7 – Image quality phantom and scatter
phantom position for whole body scan acquisition . 29 Figure 8 – Placement of ROIs in the phantom background . 32
– 4 – 61675-1 © IEC:2013 INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________
RADIONUCLIDE IMAGING DEVICES –
CHARACTERISTICS AND TEST CONDITIONS –
Part 1: 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 an
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