FprEN 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
Medizinische elektrische Geräte - Dosimeter mit Ionisationskammern und/oder Halbleiterdetektoren für den Einsatz an diagnostischen Röntgeneinrichtungen
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.
Medicinska električna oprema - Dozimetri z ionizacijskimi komorami oziroma polprevodniški detektorji, kot so uporabljeni pri rentgenskem diagnostičnem slikanju
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 61674:2023
01-april-2023
Medicinska električna oprema - Dozimetri z ionizacijskimi komorami oziroma
polprevodniški detektorji, kot so uporabljeni pri rentgenskem diagnostičnem
slikanju
Medical electrical equipment - Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
Medizinische elektrische Geräte - Dosimeter mit Ionisationskammern und/oder
Halbleiterdetektoren für den Einsatz an diagnostischen Röntgeneinrichtungen
Appareils électromédicaux - Dosimètres à chambres d’ionisation et/ou à détecteurs
semiconducteurs utilisés en imagerie de diagnostic à rayonnement X
Ta slovenski standard je istoveten z: prEN IEC 61674:2023
ICS:
11.040.50 Radiografska oprema Radiographic equipment
17.240 Merjenje sevanja Radiation measurements
oSIST prEN IEC 61674:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN IEC 61674:2023
oSIST prEN IEC 61674:2023
62C/865/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61674 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-01-27 2023-04-21
SUPERSEDES DOCUMENTS:
62C/844/CD, 62C/862A/CC
IEC SC 62C : EQUIPMENT FOR RADIOTHERAPY, NUCLEAR MEDICINE AND RADIATION DOSIMETRY
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of
• any relevant patent rights of which they are aware and to provide supporting documentation ,
• any relevant “in some countries” clauses to be included should this proposal proceed. Recipients are reminded
that the enquiry stage is the final stage for submitting "in some countries" clauses. See AC/22/2007.
TITLE:
Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as
used in X-ray diagnostic imaging
PROPOSED STABILITY DATE: 2027
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee
positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose
without permission in writing from IEC.
oSIST prEN IEC 61674:2023
62C/865/CDV – 2 – IEC 61674 CDV © IEC 2023
NOTE FROM TC/SC OFFICERS:
oSIST prEN IEC 61674:2023
IEC 61674 CDV © IEC 2023 – 3 – 62C/865/CDV
1 CONTENTS
2 FOREWORD . 5
3 INTRODUCTION . 7
4 1 Scope and object . 8
5 1.1 Scope . 8
6 1.2 Object . 8
7 2 Normative references . 8
8 3 Terms and definitions . 9
9 4 General requirements . 16
10 4.1 Performance requirements . 16
11 4.2 REFERENCE VALUES and STANDARD TEST VALUES . 16
12 4.3 General test conditions . 17
13 4.3.1 STANDARD TEST CONDITIONS . 17
14 4.3.2 Statistical fluctuations . 17
15 4.3.3 STABILIZATION TIME . 18
16 4.3.4 Adjustments during test . 18
17 4.3.5 Batteries . 18
18 4.4 Constructional requirements as related to performance . 18
19 4.4.1 Components . 18
20 4.4.2 Display . 19
21 4.4.3 Indication of battery condition . 19
22 4.4.4 Indication of polarizing voltage failure . 19
23 4.4.5 Over-ranging . 19
24 4.4.6 MEASURING ASSEMBLIES with multiple DETECTOR ASSEMBLIES . 20
25 4.4.7 Radioactive STABILITY CHECK DEVICE . 20
26 4.5 UNCERTAINTY of measurement . 20
27 5 Limits of PERFORMANCE CHARACTERISTICS . 21
28 5.1 Linearity . 21
29 5.2 Repeatability . 21
30 5.2.1 General . 21
31 5.2.2 Repeatability in the ATTENUATED BEAM . 21
32 5.2.3 Repeatability in the UNATTENUATED BEAM . 22
33 5.3 RESOLUTION of reading . 22
34 5.4 STABILIZATION TIME . 22
35 5.5 Effect of pulsed radiation on AIR KERMA and AIR KERMA LENGTH PRODUCT
36 measurements . 22
37 5.6 Stability . 23
38 5.6.1 Long term stability . 23
39 5.6.2 Accumulated dose stability . 23
40 5.7 Measurements with a radioactive STABILITY CHECK DEVICE . 23
41 6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 24
42 6.1 General . 24
43 6.2 Energy dependence of RESPONSE . 24
44 6.3 AIR KERMA RATE dependence of AIR KERMA and AIR KERMA LENGTH PRODUCT
45 measurements . 25
46 6.4 Dependence of DETECTOR RESPONSE on angle of incidence of radiation . 26
47 6.4.1 Non-CT detectors . 26
oSIST prEN IEC 61674:2023
62C/865/CDV – 4 – IEC 61674 CDV © IEC 2023
48 6.4.2 CT DETECTORS . 26
49 6.5 Operating voltage . 26
50 6.5.1 Mains-operated DOSIMETERS . 26
51 6.5.2 Battery-operated DOSIMETERS . 26
52 6.5.3 Mains rechargeable, battery-operated DOSIMETERS . 26
53 6.6 Air pressure . 27
54 6.7 Air pressure EQUILIBRATION TIME of the RADIATION DETECTOR . 27
55 6.8 Temperature and humidity . 27
56 6.9 Electromagnetic compatibility . 28
57 6.9.1 ELECTROSTATIC DISCHARGE . 28
58 6.9.2 Radiated electromagnetic fields . 28
59 6.9.3 CONDUCTED DISTURBANCES induced by bursts and radio frequencies . 29
60 6.9.4 Voltage dips, short interruptions and voltage VARIATIONS . 29
61 6.10 Field size . 29
62 6.11 EFFECTIVE LENGTH and spatial uniformity of RESPONSE of CT DOSIMETERS . 29
63 7 Marking . 30
64 7.1 DETECTOR ASSEMBLY . 30
65 7.2 MEASURING ASSEMBLY . 30
66 7.3 Radioactive STABILITY CHECK DEVICE . 30
67 8 ACCOMPANYING DOCUMENTS . 31
68 Annex A (informative) COMBINED STANDARD UNCERTAINTY for dosimeter performance . 33
69 Index of defined terms . 34
71 Table 1 – REFERENCE and STANDARD TEST CONDITIONS . 17
72 Table 2 – Number of readings required to detect true differences (95 % confidence
73 level) between two sets of instrument readings . 18
74 Table 3 – Maximum values for the COEFFICIENT OF VARIATION, v , for measurements
max
75 in the attenuated beam . 21
76 Table 4 – Maximum values for the COEFFICIENT OF VARIATION, v , for measurements
max
77 in the unattenuated beam . 22
78 Table 5 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 24
79 Table 6 – Climatic conditions . 28
80 Table A.1 – Estimation of COMBINED STANDARD UNCERTAINTY for dosimeter performance . 33
oSIST prEN IEC 61674:2023
IEC 61674 CDV © IEC 2023 – 5 – 62C/865/CDV
83 INTERNATIONAL ELECTROTECHNICAL COMMISSION
84 ____________
86 MEDICAL ELECTRICAL EQUIPMENT –
87 DOSIMETERS WITH IONIZATION CHAMBERS AND/OR
88 SEMICONDUCTOR DETECTORS AS USED
89 IN X-RAY DIAGNOSTIC IMAGING
91 FOREWORD
92 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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