IEC 61674:2024
(Main)Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
IEC 61674:2024 specifies the performance and some related constructional requirements of DIAGNOSTIC DOSIMETERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE, in photon radiation fields used in medical X-ray imaging, such as RADIOGRAPHY, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-RADIATION with generating potentials in the range of 20 kV to 150 kV. This document is applicable to the performance of DOSIMETERS with VENTED IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging.
IEC 61674:2024 cancels and replaces the second edition published in 2012. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) for mammography, the manufacturer specifies the REFERENCE VALUE for the RADIATION QUALITY;
b) for mammography, the manufacturer provides the MINIMUM RATED RANGE of RADIATION QUALITIES for the compliance test on energy dependence of response;
c) the compliance test for analogue displays was removed;
d) the compliance tests for range reset, the effect of leakage and recombination losses were removed. These tests are already covered by the test on linearity and cannot be conducted for modern devices. The estimation of COMBINED STANDARD UNCERTAINTY was changed accordingly;
e) the compliance test for mains rechargeable and battery-operated dosimeters were updated for modern devices
Appareils électromédicaux - Dosimètres à chambres d'ionisation et/ou à détecteurs semiconducteurs utilisés en imagerie de diagnostic à rayonnement X
L'IEC 61674:2024 spécifie les exigences de performance, et quelques exigences de construction associées, des dosimètres de radiodiagnostic destinés au mesurage du kerma dans l'air, du produit kerma dans l’air longueur ou du débit de kerma dans l’air, dans des champs de rayonnement de photons utilisés en imagerie médicale à rayonnement X, telle que la radiographie, la radioscopie et la tomodensitométrie (CT), pour des rayonnements X dont les potentiels se situent dans la plage comprise entre 20 kV et 150 kV. Le présent document est applicable à la performance des dosimètres à chambres d’ionisation ouvertes et/ou à détecteurs semiconducteurs utilisés en imagerie de diagnostic à rayonnement X. L'IEC 61674:2024 annule et remplace la deuxième édition de l’IEC 61674 parue en 2012. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) pour la mammographie, le fabricant spécifie la valeur de référence pour la qualité de rayonnement;
b) pour la mammographie, le fabricant fournit le domaine assigné minimal des qualités de rayonnement pour l’essai de conformité pour la dépendance de la réponse en énergie;
c) l’essai de conformité pour les affichages analogiques a été supprimé;
d) les essais de conformité relatifs à la remise à zéro dans les plages, à l’effet du courant de fuite et aux pertes de recombinaison ont été supprimés. Ces essais sont déjà couverts par l’essai de linéarité et ne peuvent pas être réalisés sur les dispositifs modernes. L’estimation de l’incertitude normalisée combinée a été modifiée en conséquence;
e) l’essai de conformité pour les dosimètres fonctionnant sur batterie rechargeable par le réseau a été mis à jour pour les dispositifs modernes.
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IEC 61674 ®
Edition 3.0 2024-07
COMMENTED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment – Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
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
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IEC 61674 ®
Edition 3.0 2024-07
COMMENTED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment – Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-9379-9
– 2 – IEC 61674:2024 CMV © IEC 2024
CONTENTS
FOREWORD .4
INTRODUCTION .7
1 Scope and object .8
1.1 Scope .8
1.2 Object .8
2 Normative references .8
3 Terms and definitions .9
4 General requirements . 17
4.1 Performance requirements . 17
4.2 REFERENCE VALUES and STANDARD TEST VALUES . 17
4.3 General test conditions . 18
4.3.1 STANDARD TEST CONDITIONS . 18
4.3.2 Statistical fluctuations . 18
4.3.3 STABILIZATION TIME . 19
4.3.4 Adjustments during test . 19
4.3.5 Batteries . 19
4.4 Constructional requirements as related to performance . 19
4.4.1 Components . 19
4.4.2 Display . 20
4.4.3 Indication of battery condition . 20
4.4.4 Indication of polarizing voltage failure . 20
4.4.5 Over-ranging . 20
4.4.6 MEASURING ASSEMBLIES with multiple DETECTOR ASSEMBLIES . 21
4.4.7 Radioactive STABILITY CHECK DEVICE . 21
4.5 UNCERTAINTY of measurement . 21
5 Limits of PERFORMANCE CHARACTERISTICS . 22
5.1 Linearity . 22
5.2 Repeatability . 22
5.2.1 General . 22
5.2.2 Repeatability in the ATTENUATED BEAM . 22
5.2.3 Repeatability in the UNATTENUATED BEAM. 23
5.3 RESOLUTION of reading . 23
5.4 STABILIZATION TIME . 23
5.5 Effect of pulsed radiation on AIR KERMA and AIR KERMA LENGTH PRODUCT
measurements . 24
5.6 Stability . 25
5.6.1 Long term stability . 25
5.6.2 Accumulated dose stability. 25
5.6 Reset on AIR KERMA and AIR KERMA LENGTH PRODUCT ranges .
5.7 Effects of LEAKAGE CURRENT .
5.7 Measurements with a radioactive STABILITY CHECK DEVICE . 25
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 26
6.1 General . 26
6.2 Energy dependence of RESPONSE . 26
6.3 AIR KERMA RATE dependence of AIR KERMA and AIR KERMA LENGTH PRODUCT
measurements . 28
6.3.1 MEASURING ASSEMBLY .
6.3.2 IONIZATION CHAMBER – Recombination losses .
6.4 Dependence of DETECTOR RESPONSE on angle of incidence of radiation . 29
6.4.1 Non-CT detectors . 29
6.4.2 CT DETECTORS . 29
6.5 Operating voltage . 29
6.5.1 Mains-operated DOSIMETERS. 29
6.5.2 Battery-operated DOSIMETERS . 29
6.5.3 Mains rechargeable, battery-operated DOSIMETERS . 30
6.6 Air pressure. 30
6.7 Air pressure EQUILIBRATION TIME of the RADIATION DETECTOR. 30
6.8 Temperature and humidity . 31
6.9 Electromagnetic compatibility . 31
6.9.1 ELECTROSTATIC DISCHARGE . 31
6.9.2 Radiated electromagnetic fields . 32
6.9.3 CONDUCTED DISTURBANCES induced by bursts and radio frequencies . 32
6.9.4 Voltage dips, short interruptions and voltage VARIATIONS . 32
6.10 Field size . 33
6.11 EFFECTIVE LENGTH and spatial uniformity of RESPONSE of CT DOSIMETERS . 33
7 Marking . 33
7.1 DETECTOR ASSEMBLY . 33
7.2 MEASURING ASSEMBLY . 33
7.3 Radioactive STABILITY CHECK DEVICE. 34
8 ACCOMPANYING DOCUMENTS . 34
Annex A (informative) Combined standard uncertainty for dosimeter performance . 36
Bibliography . 37
Index of defined terms . 38
List of comments . 41
Table 1 – REFERENCE and STANDARD TEST CONDITIONS . 17
Table 2 – Number of readings required to detect true differences ∆ (95 % confidence
level) between two sets of instrument readings . 19
Table 3 – Maximum values for the COEFFICIENT OF VARIATION, v , for measurements
max
in the attenuated beam . 23
Table 4 – Maximum values for the COEFFICIENT OF VARIATION, v , for measurements
max
in the unattenuated beam and mammography . 23
Table 5 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 27
Table 6 – Climatic conditions . 31
Table A.1 – Estimation of COMBINED STANDARD UNCERTAINTY for dosimeter performance . 36
– 4 – IEC 61674:2024 CMV © IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR
DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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4) In order to promote international uniformity, IEC National Committees undertake to a
...
IEC 61674 ®
Edition 3.0 2024-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
Appareils électromédicaux – Dosimètres à chambres d'ionisation et/ou à
détecteurs semiconducteurs utilisés en imagerie de diagnostic à rayonnement X
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 ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et
les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
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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 IEC Products & Services Portal - products.iec.ch
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a month by email.
and French, with equivalent terms in 25 additional languages.
Also known as the International Electrotechnical Vocabulary
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(IEV) online.
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IEC 61674 ®
Edition 3.0 2024-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
Appareils électromédicaux – Dosimètres à chambres d'ionisation et/ou à
détecteurs semiconducteurs utilisés en imagerie de diagnostic à rayonnement X
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-8971-6
– 2 – IEC 61674:2024 © IEC 2024
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope and object . 7
1.1 Scope . 7
1.2 Object . 7
2 Normative references . 7
3 Terms and definitions . 8
4 General requirements . 16
4.1 Performance requirements . 16
4.2 REFERENCE VALUES and STANDARD TEST VALUES . 16
4.3 General test conditions . 17
4.3.1 STANDARD TEST CONDITIONS . 17
4.3.2 Statistical fluctuations . 17
4.3.3 STABILIZATION TIME . 17
4.3.4 Adjustments during test . 18
4.3.5 Batteries . 18
4.4 Constructional requirements as related to performance . 18
4.4.1 Components . 18
4.4.2 Display . 18
4.4.3 Indication of battery condition . 18
4.4.4 Indication of polarizing voltage failure . 18
4.4.5 Over-ranging . 19
4.4.6 MEASURING ASSEMBLIES with multiple DETECTOR ASSEMBLIES . 19
4.4.7 Radioactive STABILITY CHECK DEVICE . 20
4.5 UNCERTAINTY of measurement . 20
5 Limits of PERFORMANCE CHARACTERISTICS . 20
5.1 Linearity . 20
5.2 Repeatability . 20
5.2.1 General . 20
5.2.2 Repeatability in the ATTENUATED BEAM . 21
5.2.3 Repeatability in the UNATTENUATED BEAM . 21
5.3 RESOLUTION of reading . 22
5.4 STABILIZATION TIME . 22
5.5 Effect of pulsed radiation on AIR KERMA and AIR KERMA LENGTH PRODUCT
measurements . 22
5.6 Stability. 22
5.6.1 Long term stability . 22
5.6.2 Accumulated dose stability . 23
5.7 Measurements with a radioactive STABILITY CHECK DEVICE . 23
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 23
6.1 General . 23
6.2 Energy dependence of RESPONSE . 23
6.3 AIR KERMA RATE dependence of AIR KERMA and AIR KERMA LENGTH PRODUCT
measurements . 25
6.4 Dependence of DETECTOR RESPONSE on angle of incidence of radiation . 25
6.4.1 Non-CT detectors . 25
6.4.2 CT DETECTORS . 26
6.5 Operating voltage . 26
6.5.1 Mains-operated DOSIMETERS . 26
6.5.2 Battery-operated DOSIMETERS . 26
6.5.3 Mains rechargeable, battery-operated DOSIMETERS . 26
6.6 Air pressure . 27
6.7 Air pressure EQUILIBRATION TIME of the RADIATION DETECTOR . 27
6.8 Temperature and humidity . 27
6.9 Electromagnetic compatibility . 28
6.9.1 ELECTROSTATIC DISCHARGE . 28
6.9.2 Radiated electromagnetic fields . 28
6.9.3 CONDUCTED DISTURBANCES induced by bursts and radio frequencies . 29
6.9.4 Voltage dips, short interruptions and voltage VARIATIONS . 29
6.10 Field size . 29
6.11 EFFECTIVE LENGTH and spatial uniformity of RESPONSE of CT DOSIMETERS . 29
7 Marking . 30
7.1 DETECTOR ASSEMBLY . 30
7.2 MEASURING ASSEMBLY . 30
7.3 Radioactive STABILITY CHECK DEVICE . 30
8 ACCOMPANYING DOCUMENTS . 30
Annex A (informative) COMBINED STANDARD UNCERTAINTY for dosimeter performance . 32
Bibliography . 33
Index of defined terms . 34
Table 1 – REFERENCE and STANDARD TEST CONDITIONS . 16
Table 2 – Number of readings required to detect true differences ∆ (95 % confidence
level) between two sets of instrument readings . 17
Table 3 – Maximum values for the COEFFICIENT OF VARIATION, v , for measurements
max
in the attenuated beam . 21
Table 4 – Maximum values for the COEFFICIENT OF VARIATION, v , for measurements
max
in the unattenuated beam and mammography .
...
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