EN 60789:2005
(Main)Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras
Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras
Specifies test methods for declaring the characteristics of Anger type gamma cameras. The latter are composed of a collimator, a detector shield and a radiation detector assembly, together with recording and display devices. It is not within the scope of this standard to address the safety requirements to be followed by manufacturers according to EN 60601-1.
Medizinische elektrische Geräte - Merkmale und Prüfbedingungen für bildgebende Systeme in der Nuklearmedizin - Einkristall-Gamma-Kameras
Appareils électromédicaux - Caractéristiques et conditions d'essai des dispositifs d'imagerie par radionucléides - Gamma caméras de type Anger
Spécifie les méthodes d'essai en vue d'annoncer les caractéristiques des gamma caméras de type Anger. Ces dernières sont constituées d'un collimateur, d'un blindage du détecteur et d'un ensemble détecteur de rayonnement associés à des dispositifs d'enregistrement et de visualisation. Les exigences de sécurité à suivre par les fabricants conformément à la EN 60601-1 ne rentrent pas dans le domaine d'application de la présente norme.
Medicinska električna oprema - Karakteristike in preskusni pogoji za naprave za slikanje z radionuklidi - Kamere z žarki gama tipa Anger (IEC 60789:2005)
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EUROPEAN STANDARD
EN 60789 NORME EUROPÉENNE EUROPÄISCHE NORM
December 2005 CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60789:2005 E
ICS 11.040.50 Supersedes EN 60789:1993
English version
Medical electrical equipment –
Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras (IEC 60789:2005)
Appareils électromédicaux - Caractéristiques et conditions d'essai
des dispositifs d'imagerie
par radionucléides –
Gamma caméras de type Anger (CEI 60789:2005)
Medizinische elektrische Geräte - Merkmale und Prüfbedingungen für bildgebende Systeme in der Nuklearmedizin –
Einkristall-Gamma-Kameras (IEC 60789:2005)
This European Standard was approved by CENELEC on 2005-11-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
at national level by publication of an identical
national standard or by endorsement
(dop)
2006-08-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)
2008-11-01 In this standard the following print types are used: – requirements, compliance with which can be tested, and definitions: in roman type; – notes, explanations, advice, introductions, general statements, exceptions and reference: in smaller roman type; – test specifications: in italic type; – TERMS DEFINED IN CLAUSE 3 OF THIS STANDARD LISTED IN ANNEX B: SMALL CAPITALS. The requirements are followed by specifications for the relevant tests. Annex ZA has been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 60789:2005 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 NOTE Harmonized as EN 60601-1:1990 (not modified).
IEC 61675-1 NOTE Harmonized as EN 61675-1:1998 (not modified).
IEC 61675-2 NOTE Harmonized as EN 61675-2:1998 (not modified). __________
- 3 - EN 60789:2005
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications The following referenced documents are indispensable for the application 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 Where 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
- -
NORME INTERNATIONALECEIIEC INTERNATIONAL STANDARD 60789Troisième éditionThird edition2005-10 Appareils électromédicaux – Caractéristiques et conditions d'essai des dispositifs d'imagerie par radionucléides – Gamma caméras de type Anger
Medical electrical equipment – Characteristics and test conditions of radionuclide imaging devices – Anger type gamma cameras
Pour prix, voir catalogue en vigueur For price, see current catalogue IEC 2005
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Web: www.iec.ch CODE PRIX PRICE CODE U Commission Electrotechnique InternationaleInternational Electrotechnical Commission
60789 IEC:2005 – 3 – CONTENTS
FOREWORD.5 INTRODUCTION.9
1 Scope.11 2 Normative references.11 3 Terms and definitions.11 4 Test methods.17 4.1 General requirements.17 4.2 SYSTEM SENSITIVITY.17 4.3 SPATIAL RESOLUTION.21 4.4 SPATIAL NON-LINEARITY.25 4.5 NON-UNIFORMITY OF RESPONSE.27 4.6 INTRINSIC ENERGY RESOLUTION.31 4.7 INTRINSIC MULTIPLE WINDOW SPATIAL REGISTRATION.31 4.8 COUNT RATE CHARACTERISTIC.35 4.9 Shield leakage test.37 5 ACCOMPANYING DOCUMENTS.39
Bibliography.53 Index of defined terms.55
Figure 1 – Cuvette.39 Figure 2 – Cylindrical phantom.41 Figure 3 – Uniform source.41 Figure 4 – Slit phantom for measurement of intrinsic resolution and SPATIAL NON-LINEARITY.43 Figure 5 – Source arrangement for intrinsic measurements (4.3.5, 4.4.1, 4.5.4 and 4.6).45 Figure 6 – Small shielded liquid source.47 Figure 7 – Measurement of FWHM.49 Figure 8 – Evaluation of EQUIVALENT WIDTH (EW).51
Table 1 – Radionuclides and energy windows
to be used for performance measurements.17
60789 IEC:2005 – 5 – INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________
MEDICAL ELECTRICAL EQUIPMENT – CHARACTERISTICS AND TEST CONDITIONS OF
RADIONUCLIDE IMAGING DEVICES –
ANGER TYPE GAMMA CAMERAS
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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 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 60789 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 third edition cancels and replaces the second edition published in 1992. It constitutes a technical revision. With respect to the second edition, the measurement of intrinsic point source sensitivity variation has been removed, the subclauses SYSTEM SENSITIVITY ( 4.2), SPATIAL RESOLUTION ( 4.3),NON-UNIFORMITY OF RESPONSE ( 4.5), INTRINSIC MULTIPLE WINDOW SPATIAL REGISTRATION ( 4.7) and COUNT RATE CHARACTERISTIC ( 4.8) have been reformulated (although the procedures are mostly unchanged) and some small editorial changes have been made.
60789 IEC:2005 – 7 – The text of this standard is based on the following documents: FDIS Report on voting 62C/388/FDIS 62C/392/RVD
Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard the following print types are used: – requirements, compliance with which can be tested, and definitions: in roman type; – notes, explanations, advice, introductions, general statements, exceptions and reference: in smaller roman type; – test specifications: in italic type; – TERMS DEFINED IN CLAUSE 3 OF THIS STANDARD LISTED IN ANNEX B: SMALL CAPITALS.
The requirements are followed by specifications for the relevant tests. The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the specific publication. At this date, the publication will be
• reconfirmed; • withdrawn; • replaced by a revised edition, or • amended.
60789 IEC:2005 – 9 – INTRODUCTION The test
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