EN 61674:2013

SLOVENSKI STANDARD
01-junij-2013
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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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