EN 60789:2005

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)

General Information

• Status: Withdrawn
• Publication Date: 30-Nov-2005
• Withdrawal Date: 31-Oct-2008
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 10-Sep-2018
• Completion Date: 10-Sep-2018
• Ref Project: SIST EN 60789:2007 - Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras

Relations

• Replaces: EN 60789:1993 - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras
• Effective Date: 29-Jan-2023
• Replaced By: EN 61675-2:2015 - Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar, wholebody, and SPECT imaging
• Effective Date: 10-Nov-2015

Standards Content (Sample)

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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.



EN 60789:2005 - 2 - Foreword The text of document 62C/388/FDIS, future edition 3 of IEC 60789, 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 was approved by CENELEC as EN 60789 on 2005-11-01. This European Standard supersedes EN 60789:1993. With respect to EN 60789:1993, 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. The following dates were fixed: – latest date by which the EN has to be implemented
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 o
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