EN IEC 61674:2024

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 in/ali polprevodniški detektorji, kot se uporabljajo pri rentgenskem diagnostičnem slikanju (IEC 61674:2024)

Standard IEC 61674:2024 določa zmogljivost in nekatere povezane zahteve za izdelavo DIAGNOSTIČNIH DOZIMETROV, namenjenih za merjenje KERME V ZRAKU, PRODUKTA DOLŽINE KERME V ZRAKU ali HITROSTI KERME V ZRAKU v poljih fotonskega sevanja, ki se uporabljajo pri rentgenskem slikanju (npr. RADIOGRAFIJA, RADIOSKOPIJA in RAČUNALNIŠKA TOMOGRAFIJA (CT)) za RENTGENSKO SEVANJE, ki ustvarja potenciale v razponu od 20 kV do 150 kV. Ta dokument se uporablja za zmogljivost DOZIMETROV s PREZRAČEVANIMI IONIZACIJSKIMI KOMORAMI in/ali POLPREVODNIŠKIMI DETEKTORJI, kot se uporabljajo pri rentgenskem diagnostičnem slikanju.
Standard IEC 61674:2024 razveljavlja in nadomešča drugo izdajo, objavljeno leta 2012. Ta izdaja je tehnično popravljena izdaja.
Ta izdaja v primerjavi s prejšnjo vključuje naslednje pomembne tehnične spremembe:
a) za mamografijo proizvajalec določi REFERENČNO VREDNOST za KAKOVOST SEVANJA;
b) za mamografijo proizvajalec navede NAJMANJŠE NAZIVNO OBMOČJE KAKOVOSTI SEVANJA za preskus skladnosti v zvezi z energijsko odvisnostjo odziva;
c) preskus skladnosti za analogne prikaze je bil odstranjen;
d) preskusi skladnosti za ponastavitev območja, učinek uhajanja in rekombinacijske izgube so bili odstranjeni. Ti preskusi so že zajeti s preskusom linearnosti in jih ni mogoče izvesti za sodobne naprave. Ocena KOMBINIRANE STANDARDNE NEGOTOVOSTI je bila ustrezno spremenjena;
e) preskus skladnosti za dozimetre, ki se napajajo prek omrežja in baterije, je bil posodobljen za sodobne naprave.

General Information

• Status: Published
• Publication Date: 29-Aug-2024
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 30-Aug-2024
• Due Date: 04-Jul-2025
• Completion Date: 30-Aug-2024
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN IEC 61674:2024 - Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging (IEC 61674:2024)

Relations

• Replaces: EN 61674:2013 - Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
• Effective Date: 26-Jul-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2024
Medicinska električna oprema - Dozimetri z ionizacijskimi komorami in/ali
polprevodniški detektorji, kot se uporabljajo pri rentgenskem diagnostičnem
slikanju (IEC 61674:2024)
Medical electrical equipment - Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging (IEC 61674:2024)
Medizinische elektrische Geräte - Dosimeter mit Ionisationskammern und/oder
Halbleiterdetektoren für den Einsatz an diagnostischen Röntgeneinrichtungen (IEC
61674:2024)
Appareils électromédicaux - Dosimètres à chambres d’ionisation et/ou à détecteurs
semiconducteurs utilisés en imagerie de diagnostic à rayonnement X (IEC 61674:2024)
Ta slovenski standard je istoveten z: EN IEC 61674:2024
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 61674

NORME EUROPÉENNE
EUROPÄISCHE NORM August 2024
ICS 11.040.50 Supersedes EN 61674:2013
English Version
Medical electrical equipment - Dosimeters with ionization
chambers and/or semiconductor detectors as used in X-ray
diagnostic imaging
(IEC 61674:2024)
Appareils électromédicaux - Dosimètres à chambres Medizinische elektrische Geräte - Dosimeter mit
d'ionisation et/ou à détecteurs semiconducteurs utilisés en Ionisationskammern und/oder Halbleiterdetektoren für den
imagerie de diagnostic à rayonnement X Einsatz an diagnostischen Röntgeneinrichtungen
(IEC 61674:2024) (IEC 61674:2024)
This European Standard was approved by CENELEC on 2024-08-13. 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,
Türkiye 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
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61674:2024 E
European foreword
The text of document 62C/909/FDIS, future edition 3 of IEC 61674, prepared by SC 62C "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry" of IEC/TC 62 "Medical equipment,
software, and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC
as EN IEC 61674:2024.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-05-13
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-08-13
document have to be withdrawn
This document supersedes EN 61674:2013 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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61674:2024 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 standard indicated:
IEC 60601-1:2005 NOTE Approved as EN 60601-1:2006 (not modified) +A11:2011
IEC 60601-1:2005/A1:2012 NOTE Approved as EN 60601-1:2006/A1:2013 (not modified)
IEC 60601-1:2005/A2:2020 NOTE Approved as EN 60601-1:2006/A2:2021 (not modified)
IEC 60601-1-3:2008 NOTE Approved as EN 60601-1-3:2008 (not modified) +A11:2016
IEC 60601-1-3:2008/A1:2013 NOTE Approved as EN 60601-1-3:2008/A1:2013 (not modified)
IEC 60601-1-3:2008/A2:2021 NOTE Approved as EN 60601-1-3:2008/A2:2021 (not modified)
IEC 60731:2011 NOTE Approved as EN 60731:2012 (not modified)
IEC 61010-1 NOTE Approved as EN 61010-1
IEC 61676:2023 NOTE Approved as EN IEC 61676:2023 (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.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60417 - Graphical symbols for use on equipment - -
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61000-4 series Electromagnetic compatibility (EMC) - Part EN IEC 61000-4 series
4: Testing and measurement techniques
IEC 61000-4-2 2008 Electromagnetic compatibility (EMC) - Part EN 61000-4-2 2009
4-2: Testing and measurement techniques
- Electrostatic discharge immunity test
IEC 61000-4-3 2020 Electromagnetic compatibility (EMC) - Part EN IEC 61000-4-3 2020
4-3 : Testing and measurement techniques
- Radiated, radio-frequency,
electromagnetic field immunity test
IEC 61000-4-4 - Electromagnetic compatibility (EMC) - Part EN 61000-4-4 -
4-4: Testing and measurement techniques
- Electrical fast transient/burst immunity
test
IEC 61000-4-6 - Electromagnetic compatibility (EMC) - Part EN IEC 61000-4-6 -
4-6: Testing and measurement techniques
- Immunity to conducted disturbances,
induced by radio-frequency fields
IEC 61000-4-11 - Electromagnetic compatibility (EMC) - Part EN 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 61187 - Electrical and electronic measuring EN 61187 -
equipment - Documentation
IEC 61267 2005 Medical diagnostic X-ray equipment - EN 61267 2006
Radiation conditions for use in the
determination of characteristics

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

IEC 61674:2024 © IEC 2024 – 3 –
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
...