EN 60731:2012

Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

IEC 60731:2011 specifies the performance requirements of radiotherapy dosimeters, intended for the measurement of absorbed dose to water or air kerma (and their rates and spatial distributions) in photon, electron, proton or heavy ion radiation fields as used in radiotherapy. The dose monitoring systems incorporated in radiotherapy treatment machines are not covered by this standard, neither are the re-entrant ionization chambers used for brachytherapy source calibration and constancy check devices. IEC 60731:2011 is applicable to the following types of dosimeter: - a) field-class dosimeters normally used for 1) in vivo skin surface or intracavitary measurements of dose on patients. 2) in vivo skin surface or intracavitary measurements of dose on patients. b) reference-class dosimeters normally used for the calibration of field-class dosimeters; c) scanning-class dosimeters normally used for relative dose distribution measurements with a scanning system such as an automatic water phantom. The object of this standard is: - to establish requirements for a satisfactory level of performance for radiotherapy dosimeters; - to standardize methods for the determination of compliance with this level of performance. Three levels of performance are specified: - a lower level of performance applying to field-class dosimeters; - a higher level of performance applying to reference-class dosimeters; - a specific level of performance applying to scanning-class dosimeters. This third edition cancels and replaces the second edition published in 1997 and its Amendment 1 (2002) and constitutes a technical revision. The technical modifications versus the second edition of this standard concerns performance requirements of radiotherapy dosimeters intended for the measurement of absorbed dose to water or air kerma in heavy ion radiation fields and scanning-class dosimeters normally used for relative dose distribution measurements with a scanning system such as an automatic water phantom.

Medizinische elektrische Geräte - Dosimeter mit Ionisationskammern zur Anwendung in der Strahlentherapie

Appareils électromédicaux - Dosimètres à chambres d'ionisation utilisés en radiothérapie

La CEI 60731:2011 spécifie les exigences de performance des dosimètres de radiothérapie, destinés à mesurer la dose absorbée dans l'eau ou le kerma dans l'air (et les débits et distributions spatiales correspondants) dans les champs de rayonnement de photons, électrons, protons ou ions lourds utilisés en radiothérapie. Les systèmes de surveillance de dose incorporés dans les appareils de radiothérapie ne sont pas visés par la présente norme, pas plus que les chambres à ions réentrants utilisés pour l'étalonnage des sources en curiethérapie et les contrôleurs de constance. La CEI 60731:2011 est applicable aux types suivants de dosimètre: a) dosimètres de classe de routine servant normalement à 1) mesurer le kerma ou la dose dans un faisceau de rayonnement, dans l'air ou dans un fantôme; 2) mesurer la dose reçue par les patients in vivo à la surface de la peau ou à l'intérieur d'une cavité. b) dosimètres de classe de référence servant normalement à étalonner les dosimètres de classe de routine. c) dosimètres de classe de balayage servant normalement à mesurer la distribution de dose relative à l'aide d'un système de balayage tel qu'un fantôme automatique de prélèvement d'eau. L'objet de la présente norme est: - de fixer les exigences pour un niveau de performance satisfaisant des dosimètres de radiothérapie; - de normaliser les méthodes servant à déterminer la conformité à ce niveau de performance. Trois niveaux de performance sont spécifiés: - le niveau le plus faible concerne les dosimètres de classe de routine; - le niveau le plus élevé concerne les dosimètres de classe de référence. - le niveau spécifique concerne les dosimètres de classe de balayage. Cette troisième édition annule et remplace la deuxième édition parue en 1997 et son Amendement 1 (2002), dont elle constitue une révision technique. Les modifications techniques apportées par rapport à la deuxième édition de la présente norme concernent les exigences de performance applicables aux dosimètres de radiothérapie destinés à être utilisés pour le mesurage de la dose absorbée dans l'eau ou du kerma dans l'air dans des champs de rayonnement d'ions lourds, et aux dosimètres de classe de balayage généralement utilisés pour les mesurages de la dose relative avec un système de balayage tel qu'un fantôme automatique de prélèvement d'eau.

Medicinska električna oprema - Dozimetri z ionizacijskimi komorami, ki se uporabljajo v radioterapiji

Ta mednarodni standard določa zahteve glede zmogljivosti DOZIMETROV ZA RADIOTERAPIJO, namenjenih za merjenje ABSORBIRANEGA ODMERKA NA VODO ali KERME V ZRAKU (in njihovih stopenj ter prostorskih razporeditev) na FOTONSKIH, ELEKTRONSKIH, protonskih ali težko ionskih POLJIH SEVANJA za uporabo v RADIOTERAPIJI. SISTEMI NADZIRANJA ODMERKOV v napravah za zdravljenje z RADIOTERAPIJO in povratne IONIZACIJSKE KOMORE, ki se uporabljajo za kalibracijo virov in preverjanje stalnosti v BRAHITERAPIJI, niso zajeti v tem standardu. Ta standard se uporablja za naslednje vrste dozimetrov: a) PODROČNI DOZIMETRI se običajno uporabljajo za 1) merjenje KERME ali odmerka v RADIOLOŠKEM ŽARKU v zraku ali na FANTOMU; 2) in vivo meritve odmerka na površini kože ali v notranjih organih pri PACIENTIH. b) REFERENČNI DOZIMETRI se običajno uporabljajo za kalibracijo PODROČNIH DOZIMETROV; OPOMBA: REFERENČNI DOZIMETRI se lahko uporabljajo kot PODROČNI DOZIMETRI. c) SKENIRNI DOZIMETRI se običajno uporabljajo za meritve relativne distribucije odmerka s SISTEMOM SKENIRANJA, kot je avtomatski vodni FANTOM.

General Information

• Status: Published
• Publication Date: 05-Apr-2012
• Withdrawal Date: 13-Mar-2015
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 06-Apr-2012
• Completion Date: 06-Apr-2012
• 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 60731:2012 - Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

Relations

• Replaces: EN 60731:1997/A1:2002 - Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
• Effective Date: 29-Jan-2023
• Replaces: EN 60731:1997 - Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
• Effective Date: 29-Jan-2023
• Amended By: EN 60731:2012/A1:2022 - Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
• Effective Date: 03-Sep-2014

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2012
0HGLFLQVNDHOHNWULþQDRSUHPD'R]LPHWUL]LRQL]DFLMVNLPLNRPRUDPLNLVH
XSRUDEOMDMRYUDGLRWHUDSLML
Medical electrical equipment - Dosimeters with ionization chambers as used in
radiotherapy
Medizinische elektrische Geräte - Dosimeter mit Ionisationskammern zur Anwendung in
der Strahlentherapie
Appareils électromédicaux - Dosimètres à chambre d'ionisation utilisés en radiothérapie
Ta slovenski standard je istoveten z: EN 60731:2012
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 60731
NORME EUROPÉENNE
April 2012
EUROPÄISCHE NORM
ICS 11.040.50 Supersedes EN 60731:1997 + A1:2002

English version
Medical electrical equipment -
Dosimeters with ionization chambers as used in radiotherapy
(IEC 60731:2011)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Dosimètres à chambres d'ionisation Dosimeter mit Ionisationskammern zur
utilisés en radiothérapie Anwendung in der Strahlentherapie
(CEI 60731:2011) (IEC 60731:2011)

This European Standard was approved by CENELEC on 2012-03-14. 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, 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

© 2012 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60731:2012 E
Foreword
The text of document 62C/506/FDIS, future edition 3 of IEC 60731, prepared by SC 62C, "Equipment for
radiotherapy, nuclear medicine and radiation dosimetry", of IEC TC 62, "Electrical equipment in medical
practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
(dop) 2012-12-14
• 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) 2015-03-14

standards conflicting with the
document have to be withdrawn
This document supersedes EN 60731:1997 + A1:2002.
EN 60731:1997 + A1:2002:
The technical modifications versus EN 60731:1997 + A1:2002 concerns performance requirements of
RADIOTHERAPY DOSIMETERS intended for the measurement of ABSORBED DOSE TO WATER or
AIR KERMA in heavy ion RADIATION FIELDS and SCANNING-CLASS DOSIMETERS normally used for
relative dose distribution measurements with a SCANNING SYSTEM such as an automatic water
PHANTOM.
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.
Endorsement notice
The text of the International Standard IEC 60731:2012 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60051-1:1997 NOTE  Harmonized as EN 60051-1:1998 (not modified).

- 3 - EN 60731:2012
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 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 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
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
1)
IEC 60601-2-8 2010 Medical electrical equipment - EN 60601-2-8 201X
Part 2-8: Particular requirements for basic
safety and essential performance of
therapeutic X-ray equipment operating in the
range 10 kV to 1 MV
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60976 2007 Medical electrical equipment - Medical EN 60976 2007
electron accelerators - Functional
performance characteristics
IEC 61010-1 2010 Safety requirements for electrical equipment EN 61010-1 2010
+ corr. May 2011 for measurement, control and laboratory use -
Part 1: General requirements
IEC 61187 - Electrical and electronic measuring equipment EN 61187 -
- Documentation
IEC 61267 2005 Medical diagnostic X-ray equipment - EN 61267 2006
Radiation conditions for use in the
determination of characteristics

IEC 61676 2002 Medical electrical equipment - Dosimetric EN 61676 2002
instruments used for non-invasive
measurement of X-ray tube voltage in
diagnostic radiology
ISO/IEC Guide 98-3 2008 Uncertainty of measurement - - -
Part 3: Guide to the expression of uncertainty
in measurement (GUM:1995)
1)
To be published.
Publication Year Title EN/HD Year
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 60731 ®
Edition 3.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dosimeters with ionization chambers as used in
radiotherapy
Appareils électromédicaux – Dosimètres à chambres d’ionisation
utilisés en radiothérapie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XD
ICS 11.040.50 ISBN 978-2-88912-382-7

– 2 – 60731 © IEC:2011
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope and object . 9
1.1 Scope . 9
1.2 Object . 9
2 Normative references . 9
3 Terms and definitions . 10
4 General requirements . 22
4.1 BASIC SAFETY and ESSENTIAL PERFORMANCE . 22
4.2 Performance requirements . 22
4.3 REFERENCE VALUES and STANDARD TEST VALUES . 22
4.4 General test conditions and methods . 23
4.4.1 STANDARD TEST CONDITIONS . 23
4.4.2 Test of components . 23
4.4.3 RATED or EFFECTIVE RANGE of dose (or KERMA) rates . 23
4.4.4 UNCERTAINTY OF MEASUREMENT . 24
4.4.5 Adjustments during test . 24
4.4.6 Test conditions particular to CHAMBER ASSEMBLIES. 24
4.4.7 Test conditions particular to MEASURING ASSEMBLIES. 24
4.4.8 Test conditions particular to STABILITY CHECK DEVICES . 25
4.4.9 Use of STABILITY CHECK DEVICES . 25
4.5 Summary tables . 25
4.6 Classification of equipment according to LIMITS OF VARIATION . 32
4.6.1 FIELD-CLASS DOSIMETER . 32
4.6.2 REFERENCE-CLASS DOSIMETER . 32
4.6.3 SCANNING-CLASS DOSIMETER . 32
5 CHAMBER ASSEMBLY performance requirements . 33
5.1 General . 33
5.2 General performance requirements for (RADIOTHERAPY) IONIZATION CHAMBERS . 33
5.2.1 CHAMBER ASSEMBLY LEAKAGE CURRENT without IRRADIATION . 33
5.2.2 Stability . 33
5.2.3 STABILIZATION TIME . 34
5.2.4 Post-irradiation leakage . 34
5.2.5 RATED or EFFECTIVE RANGE of dose rate (continuous radiation) . 35
5.2.6 Maximum RATED dose per pulse (pulsed radiation) . 36
5.2.7 RATED RANGE of field sizes . 37
5.2.8 STRAY RADIATION . 38
5.2.9 Guard/collector insulation . 38
5.2.10 Cable microphony . 39
5.2.11 Polarity of polarizing voltage effect . 39
5.2.12 ELECTROMAGNETIC COMPATIBILITY . 40
5.3 Performance requirements particular to SHELL CHAMBERS . 40
5.3.1 Dependence on RADIATION QUALITY . 40
5.3.2 RATED RANGE of field sizes . 43
5.3.3 Chamber orientation . 44
5.4 Performance requirements particular to PARALLEL-PLATE CHAMBERS . 45

60731 © IEC:2011 – 3 –
5.4.1 Dependence on RADIATION QUALITY . 46
5.4.2 Chamber orientation . 47
5.5 Performance requirements particular to VENTED CHAMBERS . 47
5.5.1 Atmospheric pressure change . 48
5.5.2 Temperature . 48
5.5.3 Humidity . 48
5.6 Performance requirements particular to SEALED CHAMBERS. 49
5.6.1 Atmospheric pressure change . 49
5.6.2 Temperature . 49
6 MEASURING ASSEMBLY performance requirements . 50
6.1 General .
...