IEC 60580:2019
(Main)Medical electrical equipment - Dose area product meters
Medical electrical equipment - Dose area product meters
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 %.
Appareils électromédicaux - Radiamètres de produit exposition-surface
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 %.
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IEC 60580 ®
Edition 3.0 2019-11
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment – Dose area product meters
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
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latest edition, a corrigendum or an amendment might have been published.
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and withdrawn publications. Also known as the International Electrotechnical Vocabulary
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IEC 60580 ®
Edition 3.0 2019-11
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment – Dose area product meters
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-7605-1
– 2 – IEC 60580:2019 RLV © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
1 Scope and object . 7
2 Normative references . 7
3 Terms and definitions . 8
4 General requirements . 15
4.1 Performance requirements . 15
4.2 Minimum EFFECTIVE RANGES of DOSE AREA PRODUCT and DOSE AREA PRODUCT
RATE . 15
4.3 Plane of measurement . 16
4.4 REFERENCE VALUES and STANDARD TEST CONDITIONS . 16
4.5 General test conditions . 16
4.5.1 STANDARD TEST CONDITIONS . 16
4.5.2 Test of components . 17
4.5.3 STABILIZATION TIME . 17
4.5.4 Adjustments during test . 17
4.5.5 Uniformity of RADIATION field . 17
4.6 Statistical fluctuations . 17
4.7 Uncertainty of measurement . 18
4.8 Constructional requirements as related to performance . 18
4.8.1 Display . 18
4.8.2 Indication of polarizing voltage failure . 19
4.8.3 Over-ranging . 19
4.8.4 Indication of reset or other inactive condition . 19
4.8.5 IONIZATION CHAMBER RADIATION DETECTOR . 19
4.9 STABILITY CHECK DEVICE . 20
4.10 Adjustment . 21
4.11 Electrical safety . 21
5 Limits of PERFORMANCE CHARACTERISTICS under STANDARD TEST CONDITIONS . 21
RELATIVE INTRINSIC ERROR .
5.1 Classification of DOSE AREA PRODUCT METERS according to LIMITS OF
VARIATION . 22
5.1.1 REFERENCE-CLASS DOSE AREA PRODUCT METERS . 22
5.1.2 FIELD-CLASS DOSE AREA PRODUCT METERS . 22
5.2 LINEARITY . 23
5.3 Warning function . 22
5.4 Repeatability . 23
5.5 RESOLUTION of reading . 24
5.6 STABILIZATION TIME . 24
5.7 Reset on DOSE AREA PRODUCT ranges . 24
5.8 Drift of INDICATED VALUES . 24
5.9 Long term stability . 25
5.10 RESPONSE TIME . 25
5.11 Spatial uniformity of RESPONSE . 26
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 26
6.1 General . 26
6.2 Energy dependence of RESPONSE . 26
6.3 DOSE AREA PRODUCT RATE dependence of DOSE AREA PRODUCT measurements. 26
6.3.1 MEASURING ASSEMBLY . 26
6.3.2 IONIZATION CHAMBER – Recombination losses . 27
6.4 IRRADIATION TIME . 27
6.5 Field size . 27
6.6 Operating voltage . 27
6.7 Air pressure . 27
6.8 Temperature and humidity . 28
6.9 Air density fluctuation in the IONIZATION CHAMBER . 28
6.10 Electromagnetic compatibility . 28
6.10.1 General . 28
6.10.2 Electrostatic discharge . 29
6.10.3 Radiated electromagnetic fields . 29
6.10.4 Conducted disturbances induced by bursts and high frequencies . 29
6.10.5 Surges . 30
6.10.6 Voltage dips, short interruptions and voltage VARIATIONS . 30
6.11 COMBINED STANDARD UNCERTAINTY . 30
7 Marking . 32
7.1 MEASURING ASSEMBLY . 33
7.2 IONIZATION CHAMBER RADIATION DETECTOR . 34
8 ACCOMPANYING DOCUMENTS . 34
Bibliography . 36
INDEX OF DEFINED TERMS . 37
Table – RELATIVE INSTRINSIC ERROR, I .
Table 1 – Minimum EFFECTIVE RANGES – DOSE AREA PRODUCT . 16
Table 2 – Minimum effective ranges – DOSE AREA PRODUCT RATE . 16
Table 3 – REFERENCE VALUES and STANDARD TEST CONDITIONS . 16
Table 4 – Number of readings required to detect true differences ∆ (95 % confidence
level) between two sets of instrument readings . 18
Table 5 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 20
Table 6 – Maximum values for the COEFFICIENT OF VARIATION, V . 24
max
Table 7 – Climatic conditions . 28
Table – Example for assessment of the COMBINED STANDARD UNCERTAINTY .
Table 8 – Example for assessment of the COMBINED STANDARD UNCERTAINTY – FIELD-
CLASS DOSE AREA PRODUCT METER . 32
Table 9 – Example for assessment of the COMBINED STANDARD UNCERTAINTY –
REFERENCE-CLASS DOSE AREA PRODUCT METER . 33
– 4 – IEC 60580:2019 RLV © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
DOSE AREA PRODUCT METERS
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
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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
...
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
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IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and Definitions clause of
IEC publications issued since 2002. Some entries have been
IEC Customer Service Centre - webstore.iec.ch/csc collected from earlier publications of IEC TC 37, 77, 86 and
If you wish to give us your feedback on this publication or CISPR.
need further assistance, please contact the Customer Service
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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
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 . 25
6.9 Air density fluctuation in the IONIZATION CHAMBER . 25
6.10 Electromagnetic compatibility . 25
6.10.1 General . 25
6.10.2 Electrostatic discharge . 26
6.10.3 Radiated electromagnetic fields . 26
6.10.4 Conducted disturbances induced by bursts and high frequencies . 26
6.10.5 Surges . 27
6.10.6 Voltage dips, short interruptions and voltage VARIATIONS . 27
6.11 COMBINED STANDARD UNCERTAINTY . 27
7 Marking . 29
7.1 MEASURING ASSEMBLY . 29
7.2 RADIATION DETECTOR . 30
8 ACCOMPANYING DOCUMENTS . 30
Bibliography . 32
INDEX OF DEFINED TERMS . 33
Table 1 – Minimum EFFECTIVE RANGES – DOSE AREA PRODUCT . 14
Table 2 – Minimum EFFECTIVE RANGES – DOSE AREA PRODUCT RATE . 14
Table 3 – REFERENCE VALUES and STANDARD TEST CONDITIONS . 15
Table 4 – Number of readings required to detect true differences ∆ (95 % confidence
level) between two sets of instrument readings . 16
Table 5 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 19
Table 6 – Maximum values for the COEFFICIENT OF VARIATION, V .
...
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