EN IEC 60580:2020
(Main)Medical electrical equipment - Dose area product meters
Medical electrical equipment - Dose area product meters
IEC 60580:2019 is available as IEC 60580:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60580:2019 specifies the performance and testing of Dose Area Product Meters intended to measure Dose Area Product and/or Dose Area Product Rate to which the Patient is exposed during Medical Radiological Examinations. This document is applicable to the following types of Dose Area Product Meters: a) Field-Class Dose Area Product Meters normally used for the measurement of Dose Area Products during Medical Radiological Examinations; b) Reference-Class Dose Area Product Meters normally used for the Calibration of Field-Class Dosimeters. NOTE Reference-Class Dose Area Product Meters can be used as Field-Class Dose Area Product Meters. The object of this document is 1) to establish requirements for a satisfactory level of performance for Dose Area Product Meters, and 2) to standardize the methods for the determination of compliance with this level of performance. Two levels of performance are specified: – a lower level of performance applying to Field-Class Dose Area Product Meters; – a higher level of performance applying to Reference-Class Dose Area Product Meters. IEC 60580:2019 cancels and replaces the second edition published 2000, and constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) a second class of devices is introduced with tighter uncertainty tolerances; b) this document has been expanded to include detectors other than ionization chambers; c) radiation qualities have been updated to the new definitions according to IEC 61267; d) a requirement on the linearity of the dose area product rate measurement was added; e) changed chamber light transmission requirement from 70 % to 60 %.
Medizinische elektrische Geräte - Dosisflächenprodukt-Messgeräte
Appareils électromédicaux - Radiamètres de produit exposition-surface
IEC 60580:2019 est disponible sous forme de IEC 60580:2019 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60580:2019 spécifie la performance et l'essai des Radiamètres de Produit Exposition-Surface destinés au mesurage du Produit Exposition-Surface et/ou du Débit de Produit Exposition-Surface auquel le Patient est exposé au cours des Examens Radiologiques Médicaux. Le présent document est applicable aux types suivants de Radiamètres de Produit Exposition-Surface: a) les Radiamètres de Produit Exposition-Surface de Classe de Routine normalement utilisés pour le mesurage des Produits Exposition-Surface au cours des Examens Radiologiques Médicaux; b) les Radiamètres de Produit Exposition-Surface de Classe de Référence normalement utilisés pour l’Étalonnage des Dosimètres de Classe de Routine. NOTE Les Radiamètres de Produit Exposition-Surface de Classe de Référence peuvent être utilisés en tant que Radiamètres de Produit Exposition-Surface de Classe de Routine. L’objet du présent document est 1) d'établir les exigences pour assurer un niveau de performance satisfaisant des Radiamètres de Produit Exposition-Surface, et 2) de normaliser les méthodes pour déterminer la conformité à ce niveau de performance. Deux niveaux de performance sont spécifiés: – un niveau inférieur de performance applicable aux Radiamètres de Produit Exposition-Surface de Classe de Routine; – un niveau supérieur de performance applicable aux Radiamètres de Produit Exposition-Surface de Classe de Référence. L'IEC 60580:2019 annule et remplace la deuxième édition parue en 2000, et constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) une deuxième classe de dispositifs a été introduite, avec des tolérances d’incertitude plus strictes; b) la présente norme a été étendue pour inclure les détecteurs autres que les chambres d’ionisation; c) les qualités de rayonnement ont été mises à jour en fonction des nouvelles définitions de l’IEC 61267; d) une exigence relative à la linéarité du mesurage du débit de produit exposition-surface a été ajoutée; e) l’exigence relative à la transmission lumineuse de la chambre a été modifiée, passant de 70 % à 60 %.
Medicinska električna oprema - Merilniki produkta površina-doza (IEC 60580:2019)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2020
Nadomešča:
SIST EN 60580:2002
Medicinska električna oprema - Merilniki produkta površina-doza (IEC 60580:2019)
Medical electrical equipment - Dose area product meters (IEC 60580:2019)
Medizinische elektrische Geräte - Dosisflächenprodukt-Messgeräte (IEC 60580:2019)
Appareils électromédicaux - Radiamètres de produit exposition-surface (IEC
60580:2019)
Ta slovenski standard je istoveten z: EN IEC 60580:2020
ICS:
11.040.50 Radiografska oprema Radiographic equipment
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60580
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.040.50 Supersedes EN 60580:2000 and all of its amendments
and corrigenda (if any)
English Version
Medical electrical equipment - Dose area product meters
(IEC 60580:2019)
Appareils électromédicaux - Radiamètres de produit Medizinische elektrische Geräte - Dosisflächenprodukt-
exposition-surface Messgeräte
(IEC 60580:2019) (IEC 60580:2019)
This European Standard was approved by CENELEC on 2019-12-17. 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 60580:2020 E
European foreword
The text of document 62C/744/FDIS, future edition 3 of IEC 60580, 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
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
document have to be withdrawn
This document supersedes EN 60580:2000 and all of its amendments and corrigenda (if any).
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.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association.
Endorsement notice
The text of the International Standard IEC 60580:2019 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60731:2011 NOTE Harmonized as EN 60731:2012 (not modified)
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 60417-1 - Graphical symbols for use on equipment_- - -
Part_1: Overview and application
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
IEC 60601-1-2 - Medical electrical equipment - Part 1-2: EN 60601-1-2 -
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 61000-4-2 - Electromagnetic compatibility (EMC) - PartE N 61000-4-2 -
4-2: Testing and measurement techniques
- Electrostatic discharge immunity test
IEC 61000-4-3 - Electromagnetic compatibility (EMC) -- PartE N 61000-4-3 -
4-3: Testing and measurement techniques
- Radiated, radio-frequency,
electromagnetic field immunity test
IEC 61000-4-4 - Electromagnetic compatibility (EMC) -- PartE N 61000-4-4 -
4-4: Testing and measurement techniques
- Electrical fast transient/burst immunity
test
IEC 61000-4-5 - Electromagnetic compatibility (EMC) - PartE N 61000-4-5 -
4-5: Testing and measurement techniques
- Surge immunity test
IEC 61000-4-6 - Electromagnetic compatibility (EMC) - PartE N 61000-4-6 -
4-6: Testing and measurement techniques
- Immunity to conducted disturbances,
induced by radio-frequency fields
Publication Year Title EN/HD Year
IEC 61000-4-11 - Electromagnetic compatibility (EMC) - PartEN IEC 61000-4-11 -
4-11: Testing and measurement
techniques - Voltage dips, short
interruptions and voltage variations
immunity tests for equipment with input
current up to 16 A per phase
IEC 61185 - Ferrite cores (ETD-cores) intended for use EN 61185 -
in power supply applications - Dimensions
IEC 61267 - Medical diagnostic X-ray equipment - EN 61267 -
Radiation conditions for use in the
determination of characteristics
IEC 62368-1 - Audio/video, information and EN IEC 62368-1 -
communication technology equipment -
Part 1: Safety requirements
+prAB
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60580 ®
Edition 3.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dose area product meters
Appareils électromédicaux – Radiamètres de produit exposition-surface
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-7591-7
– 2 – IEC 60580:2019 © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 General requirements . 14
4.1 Performance requirements . 14
4.2 Minimum EFFECTIVE RANGES of DOSE AREA PRODUCT and DOSE AREA PRODUCT
RATE . 14
4.3 Plane of measurement . 14
4.4 REFERENCE VALUES and STANDARD TEST CONDITIONS . 14
4.5 General test conditions . 15
4.5.1 STANDARD TEST CONDITIONS . 15
4.5.2 Test of components . 15
4.5.3 STABILIZATION TIME . 15
4.5.4 Adjustments during test . 16
4.5.5 Uniformity of RADIATION field . 16
4.6 Statistical fluctuations . 16
4.7 Uncertainty of measurement . 17
4.8 Constructional requirements as related to performance . 17
4.8.1 Display . 17
4.8.2 Indication of polarizing voltage failure . 17
4.8.3 Over-ranging . 17
4.8.4 Indication of reset or other inactive condition . 18
4.8.5 RADIATION DETECTOR . 18
4.9 STABILITY CHECK DEVICE . 18
4.10 Adjustment . 19
4.11 Electrical safety . 20
5 Limits of PERFORMANCE CHARACTERISTICS under STANDARD TEST CONDITIONS . 20
5.1 Classification of DOSE AREA PRODUCT METERS according to LIMITS OF
VARIATION . 20
5.1.1 REFERENCE-CLASS DOSE AREA PRODUCT METERS . 20
5.1.2 FIELD-CLASS DOSE AREA PRODUCT METERS . 20
5.2 LINEARITY . 20
5.3 Warning function . 20
5.4 Repeatability . 21
5.5 RESOLUTION of reading . 21
5.6 STABILIZATION TIME . 21
5.7 Reset on DOSE AREA PRODUCT ranges . 21
5.8 Drift of INDICATED VALUES . 21
5.9 Long term stability . 22
5.10 RESPONSE TIME . 22
5.11 Spatial uniformity of RESPONSE . 23
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 23
6.1 General . 23
6.2 Energy dependence of RESPONSE . 23
IEC 60580:2019 © IEC 2019 – 3 –
6.3 DOSE AREA PRODUCT RATE dependence of DOSE AREA PRODUCT measurements. 23
6.3.1 MEASURING ASSEMBLY . 23
6.3.2 IONIZATION CHAMBER – Recombination losses . 24
6.4 IRRADIATION TIME . 24
6.5 Field size . 24
6.6 Operating voltage . 24
6.7 Air pressure . 25
6.8 Temperature and humidity .
...
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