EN 61674:2013

Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging

IEC 61674:2012 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 radiography, including mammography, radioscopy and computed tomography, for X-radiation with generating potentials not greater than 150 kV. This International Standard is applicable to the performance of dosimeters with vented ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging. The object of this standard is to establish requirements for a satisfactory level of performance for diagnostic dosimeters, and to standardize the methods for the determination of compliance with this level of performance. This standard is not concerned with the safety aspects of dosimeters. The diagnostic dosimeters covered by this standard are not intended for use in the patient environment and, therefore, the requirements for electrical safety applying to them are contained in IEC 61010-1. This second edition cancels and replaces the first edition and constitutes a technical revision.

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 à semi-conducteurs utilisés en imagerie de diagnostic à rayonnement X

La CEI 61674:2012 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 radiographie, incluant la mammographie, la radioscopie et la tomodensitométrie, pour des rayonnements X dont le potentiel ne dépasse pas 150 kV. La présente Norme Internationale est applicable à la performance des dosimètres à chambres d'ionisation ouvertes et/ou à détecteurs a semi-conducteurs utilisés en imagerie de diagnostic à rayonnement X. L'objet de la présente norme est d'établir des exigences pour un niveau satisfaisant de performance des dosimètres de radiodiagnostic, et de normaliser les méthodes pour déterminer la conformité avec ce niveau de performance. La présente norme ne s'applique pas aux aspects de sécurité des dosimètres. Les dosimètres de radiodiagnostic couverts par la présente norme ne sont pas destinés à être utilisés dans l'environnement du patient et, par conséquent, les exigences de sécurité électrique applicables sont contenues dans la CEI 61010-1. Cette deuxième édition annule et remplace la première édition, elle constitue une révision technique.

Medicinska električna oprema - Dozimetri z ionizacijskimi komorami oziroma polprevodniški detektorji, kot so uporabljeni pri rentgenskem diagnostičnem slikanju

Ta mednarodni standard navaja zmogljivost in nekatere povezane zahteve za izdelavo DIAGNOSTIČNIH DOZIMETROV, ki so namenjeni merjenju KERME V ZRAKU, PRODUKTA DOLŽINE KERME V ZRAKU ali HITROSTI KERME V ZRAKU v poljih fotonskega sevanja, ki se uporabljajo v RADIOGRAFIJI, kar vključuje mamografijo, RADIOSKOPIJO in RAČUNALNIŠKO TOMOGRAFIJO (CT), za rentgensko sevanje, ki ustvarja potenciale, manjše od 150 kV. Ta mednarodni standard se uporablja za zmogljivost DOZIMETROV s PREZRAČEVANIMI IONIZACIJSKIMI KOMORAMI in/ali POLPREVODNIŠKIMI DETEKTORJI, kot so uporabljeni pri rentgenskem diagnostičnem slikanju.

General Information

• Status: Published
• Publication Date: 21-Feb-2013
• Withdrawal Date: 02-Jan-2016
• 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: 22-Feb-2013
• Completion Date: 22-Feb-2013
• 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 61674:2013 - Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging

Relations

• Replaces: EN 61674:1997 - Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging
• Effective Date: 28-Jan-2023
• Replaces: EN 61674:1997/A1:2002 - Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 61674:2024 - 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-junij-2013
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SROSUHYRGQLãNLGHWHNWRUMLNRWVRXSRUDEOMHQLSULUHQWJHQVNHPGLDJQRVWLþQHP
VOLNDQMX
Medical electrical equipment - Dosimeters with ionization chambers and/or semi-
conductor detectors as used in X-ray diagnostic imaging
Appareils électromédicaux - Dosimètres à chambres d'ionisation et/ou à détecteurs à
semi-conducteurs utilisés en imagerie de diagnostic à rayonnement X
Ta slovenski standard je istoveten z: EN 61674:2013
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 61674
NORME EUROPÉENNE
February 2013
EUROPÄISCHE NORM
ICS 11.040.50 Supersedes EN 61674:1997 + A1:2002

English version
Medical electrical equipment -
Dosimeters with ionization chambers and/or semiconductor detectors as
used in X-ray diagnostic imaging
(IEC 61674:2012)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Dosimètres à chambres d'ionisation et/ou Dosimeter mit Ionisationskammern
à détecteurs à semi-conducteurs utilisés und/oder Halbleiterdetektoren für den
en imagerie de diagnostic Einsatz an diagnostischen
à rayonnement X Röntgeneinrichtungen
(CEI 61674:2012) (IEC 61674:2012)

This European Standard was approved by CENELEC on 2013-01-03. 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, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61674:2013 E
Foreword
The text of document 62C/551/FDIS, future edition 2 of IEC 61674, prepared by IEC TC 62 "Electrical
equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 61674:2013.
The following dates are fixed:
(dop) 2013-10-03
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2016-01-03
standards conflicting with the

document have to be withdrawn
This document supersedes EN 61674:1997 + A1:2002.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF EN 60601-1, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.

Endorsement notice
The text of the International Standard IEC 61674:2012 was approved by CENELEC as a European
Standard without any modification.

- 3 - EN 61674:2013
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

IEC 60050 Series International Electrotechnical Vocabulary - -

IEC 60417 Data- Graphical symbols for use on equipment - -
base
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
+ corr. December 2006 Part 1: General requirements for basic safety + corr. March 2010
+ corr. December 2007 and essential performance + A11 2011

IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment
IEC 60731 2011 Medical electrical equipment - Dosimeters EN 60731 2012
with ionization chambers as used in
radiotherapy
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61000-4 Series Electromagnetic compatibility (EMC) - EN 61000-4 Series
Part 4: Testing and measurement techniques

IEC 61000-4-2 - Electromagnetic compatibility (EMC) - EN 61000-4-2 -
Part 4-2: Testing and measurement
techniques - Electrostatic discharge immunity
test
IEC 61000-4-3 - Electromagnetic compatibility (EMC) - EN 61000-4-3 -
Part 4-3: Testing and measurement
techniques - Radiated, radio-frequency,
electromagnetic field immunity test

IEC 61000-4-4 - Electromagnetic compatibility (EMC) - EN 61000-4-4 -
Part 4-4: Testing and measurement
techniques - Electrical fast transient/burst
immunity test
IEC 61000-4-6 - Electromagnetic compatibility (EMC) - EN 61000-4-6 -
Part 4-6: Testing and measurement
techniques - Immunity to conducted
disturbances, induced by radio-frequency
fields
IEC 61000-4-11 - Electromagnetic compatibility (EMC) - EN 61000-4-11 -
Part 4-11: Testing and measurement
techniques - Voltage dips, short interruptions
and voltage variations immunity tests

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

ISO/IEC Guide 98-3 2008 Uncertainty of measurement - - -
Part 3: Guide to the expression of uncertainty
in measurement (GUM:1995)
ISO/IEC Guide 99 2007 International vocabulary of metrology - Basic - -
and general concepts and associated terms
(VIM)
ISO 3534-1 2006 Statistics - Vocabulary and symbols - - -
Part 1: General statistical terms and terms
used in probability
IEC 61674 ®
Edition 2.0 2012-11
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 à semi-conducteurs utilisés en imagerie de diagnostic à

rayonnement X
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX W
ICS 11.040.50 ISBN 978-2-83220-510-5

– 2 – 61674 © IEC:2012
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 . 15
4.1 Performance requirements . 15
4.2 REFERENCE VALUES and STANDARD TEST VALUES . 15
4.3 General test conditions . 16
4.3.1 STANDARD TEST CONDITIONS . 16
4.3.2 Statistical fluctuations . 17
4.3.3 STABILIZATION TIME . 17
4.3.4 Adjustments during test . 17
4.3.5 Batteries . 17
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 . 18
4.4.6 MEASURING ASSEMBLIES with multiple DETECTOR ASSEMBLIES . 19
4.4.7 Radioactive STABILITY CHECK DEVICE . 19
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 . 20
5.2.3 Repeatability in the UNATTENUATED BEAM . 21
5.3 RESOLUTION of reading . 21
5.4 STABILIZATION TIME . 21
5.5 Effect of pulsed radiation on AIR KERMA and AIR KERMA LENGTH PRODUCT
measurements . 22
5.6 Reset on AIR KERMA and AIR KERMA LENGTH PRODUCT ranges . 22
5.7 Effects of LEAKAGE CURRENT . 22
5.7.1 AIR KERMA RATE measurements . 22
5.7.2 AIR KERMA and AIR KERMA LENGTH PRODUCT measurements . 22
5.8 Stability . 23
5.8.1 Long term stability . 23
5.8.2 Accumulated dose stability . 23
5.9 Measurements with a radioactive STABILITY CHECK DEVICE . 23
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 24
6.1 General . 24
6.2 Energy dependence of RESPONSE . 24

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