EN 62467-1:2015
(Main)Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
IEC 62467-1:2009 specifies the performance and some related constructional requirements of well-type ionization chambers and associated measurement apparatus, intended for the determination of a quantity, such as air kerma strength or reference air kerma rate in photon radiation fields or absorbed dose to water at a depth, in photon and beta radiation fields used in brachytherapy, after appropriate calibration for a given type of source. IEC 62467-1:2009 covers the techniques for the quantification of the quantity appropriate for the brachytherapy source under consideration. This quantity may be air kerma strength or reference air kerma rate at 1 m, or absorbed dose to water at a depth (e.g. 2 mm or 5 mm). Measurement of these quantities may be accomplished by a variety of well-type ionization chambers or systems currently available for this purpose. This standard applies to products intended for low dose rate, high dose rate, intravascular, both photon and beta, brachytherapy measurements. It does not apply to instruments for nuclear medicine applications. The application of the standard is limited to instruments that incorporate well-type ionization chambers as detectors. The intended use is the measurement of the output of radioactive, encapsulated sources for intracavitary (insertion into body cavities) or interstitial (insertion into body tissue) applications. The object of IEC 62467-1:2009 is a) to establish requirements for a satisfactory level of performance for well-type chamber systems, and b) to standardize the methods for the determination of compliance with this level of performance. IEC 62467-1:2009 is not concerned with the safety aspects of well-type chamber systems. The well-type chamber systems covered by this standard are not intended for use in patient environment. The electrical safety of well-type chamber systems is covered in IEC 61010-1. The operation of the electrometer measuring system is covered in IEC 60731.
Medizinische elektrische Geräte - Dosimetriegeräte zur Anwendung in der Brachytherapie - Teil 1: Messgeräte mit Schachtionisationskammern
Appareils électromédicaux - Instruments de dosimétrie utilisés en curiethérapie - Partie 1: Instruments conçus pour les chambres d’ionisation à puits
La CEI 62467-1:2009 spécifie les exigences de performance et quelques exigences de construction liées des chambres d'ionisation à puits et des appareils de mesure associés, destinés à la détermination d'une grandeur, comme par exemple l'intensité de kerma dans l'air ou le débit de kerma dans l'air de référence dans des faisceaux de rayonnement de photons, ou la dose absorbée dans l'eau à une certaine profondeur dans des faisceaux de rayonnements de photons et bêta utilisés en curiethérapie, après un étalonnage approprié pour un type donné de source. La CEI 62467-1:2009 traite des techniques pour la quantification de la grandeur appropriée à la source de curiethérapie à l'étude. Cette grandeur peut être l'intensité de kerma dans l'air ou le débit de kerma dans l'air de référence à 1 m, ou la dose absorbée dans l'eau à une certaine profondeur (par exemple, 2 mm ou 5 mm). La mesure de ces grandeurs peut être réalisée par une variété de chambres ou de systèmes d'ionisation à puits actuellement disponibles à cet effet. La CEI 62467-1:2009 s'applique aux produits destinés aux mesures de débits de dose faibles, de débits de dose élevés, intravasculaires, des rayonnements de photons et bêta, et de curiethérapie. Elle ne s'applique pas aux instruments utilisés en médecine nucléaire. L'application de la norme est limitée aux instruments qui comportent des chambres d'ionisation à puits comme détecteurs. L'utilisation prévue est la mesure des sources radioactives scellées pour les applications intracavitaires (insertion dans les cavités du corps) ou interstitielles (insertion dans les tissus du corps). L'objet de la CEI 62467-1:2009 est le suivant: a) établir des exigences pour un niveau satisfaisant de performance des systèmes de chambres à puits, et b) normaliser les méthodes pour déterminer la conformité avec ce niveau de performance. La CEI 62467-1:2009 ne s'applique pas aux aspects de sécurité des systèmes de chambres à puits. Les systèmes de chambres à puits traités dans la présente Norme ne sont pas destinés à être utilisés dans l'environnement du patient. La sécurité électrique des systèmes de chambres à puits est traitée dans la CEI 61010-1. Le fonctionnement du système de mesure de l'électromètre est traité dans à la CEI 60731.
Medicinska električna oprema - Dozimetrični instrumenti, ki se uporabljajo pri brahiterapiji - 1. del: Instrumenti na osnovi jaškastih ionizacijskih komor
IEC 62467-1:2009 določa lastnosti in nekatere povezane zahteve glede konstrukcije jaškastih ionizacijskih komor in povezanega merilnega aparata, ki so namenjeni za določevanje izbrane količine, kot je količina kerme v zraku ali referenčna stopnja kerme v zraku v poljih fotonskega sevanja ali absorbirani odmerek v vodi na globini v poljih fotonskega in beta sevanja, ki se uporabljajo v brahiterapiji, po ustreznem umerjanju za izbrano vrsto vira. IEC 62467-1:2009 obravnava tehnike za kvantifikacijo količine glede na obravnavani vir brahiterapije. Ta količina je lahko količina kerme v zraku ali referenčna stopnja kerme v zraku pri 1 m ali absorbirani odmerek v vodi na globini (npr. 2 mm ali 5 mm). Te količine je mogoče izmeriti v različnih jaškastih ionizacijskih komorah ali sistemih, ki so trenutno na voljo za ta namen. Ta standard se uporablja za izdelke, namenjene za fotonske ali beta brahiterapevtske meritve z nizko ali visoko stopnjo odmerka. Ne uporablja se za instrumente, ki se uporabljajo v nuklearni medicini. Uporaba standarda je omejena na instrumente, pri katerih se kot detektorji uporabljajo jaškaste ionizacijske komore. Predvidena uporaba je merjenje izhodnih vrednosti radioaktivnih enkapsuliranih virov za intrakavitarno (vstavitev v telesne votline) ali intersticijsko (vstavitev v kožno tkivo) uporabo. Predmet standarda IEC 62467-1:2009 je a) določitev zahtev za zadovoljivo raven delovanja za sisteme jaškastih ionizacijskih komor in b) standardizacija metod za določevanje skladnosti s to ravnjo delovanja. Standard IEC 62467-1:2009 ni povezan z varnostnimi vidiki jaškastih ionizacijskih komor. Sistemi jaškastih ionizacijskih komor, obravnavani v tem standardu, niso namenjeni za uporabo v okolju pacienta. Električno varnost sistemov jaškastih ionizacijskih komor obravnava IEC 61010-1. Delovanje merilnega sistema z električnimi števci obravnava IEC 60731.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2015
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EUDKLWHUDSLMLGHO ,QVWUXPHQWLQDRVQRYLMDãNDVWLKLRQL]DFLMVNLKNRPRU
Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1:
Instruments based on well-type ionization chambers
Appareils électromédicaux - Instruments de dosimétrie utilisés en curiethérapie - Partie
1: Instruments conçus pour les chambers d’ionisation à puits
Ta slovenski standard je istoveten z: EN 62467-1:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 62467-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2015
ICS 11.040.50; 11.040.60
English Version
Medical electrical equipment - Dosimetric instruments as used in
brachytherapy - Part 1: Instruments based on well-type
ionization chambers
(IEC 62467-1:2009)
Appareils électromédicaux - Instruments de dosimétrie Medizinische elektrische Geräte - Dosimetriegeräte zur
utilisés en curiethérapie - Partie 1: Instruments conçus pour Anwendung in der Brachytherapie - Teil 1: Messgeräte mit
les chambres d'ionisation à puits Schachtionisationskammern
(IEC 62467-1:2009) (IEC 62467-1:2009)
This European Standard was approved by CENELEC on 2015-09-15. 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.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 62467-1:2015 E
European foreword
The text of document 62C/460/FDIS, future edition 1 of IEC 62467-1, 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:
• latest date by which the document has to be implemented at (dop) 2016-06-15
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn
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.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 62467-1:2009 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 standards indicated:
IEC 60601-1-3:2008 NOTE Harmonized as EN 60601-1-3:2008 (not modified).
IEC 61010-1 NOTE Harmonized as EN 61010-1.
IEC 61676:2002 NOTE Harmonized as EN 61676:2002 (not modified).
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 1 When 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.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60050-393 2003 International Electrotechnical Vocabulary - - -
Part 393: Nuclear instrumentation -
Physical phenomena and basic concepts
IEC 60417 - Graphical symbols for use on equipment - -
IEC 60580 2000 Medical electrical equipment - Dose area EN 60580 2000
product meters
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
- - + corrigendum Mar. 2010
safety and essential performance
- - + A12 2014
IEC 60731 1997 Medical electrical equipment - Dosimeters - -
with ionization chambers as used in
radiotherapy
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61187 - Electrical and electronic measuring EN 61187 -
equipment - Documentation
IEC 61674 1997 Medical electrical equipment - Dosimeters EN 61674 1997
with ionization chambers and/or semi-
conductor detectors as used in X-ray
diagnostic imaging
ISO/IEC Guide 99 2007 International vocabulary of metrology - - -
Basic and general concepts and
associated terms (VIM)
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 62467-1 ®
Edition 1.0 2009-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dosimetric instruments as used in
brachytherapy –
Part 1: Instruments based on well-type ionization chambers
Appareils électromedicaux – Instruments de dosimétrie utilisés en
curiethérapie –
Partie 1: Instruments conçus pour les chambres d’ionisation à puits
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
T
CODE PRIX
ICS 11.040.50; 11.040.60 ISBN 978-2-88910-735-3
– 2 – 62467-1 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope and object.7
2 Normative references .7
3 Terms and definitions .8
4 General requirements .12
4.1 PERFORMANCE REQUIREMENTS.12
4.2 MEASURING ASSEMBLY .12
4.3 Source types .12
4.3.1 General .12
4.3.2 Beta particle-emitting sources .13
4.3.3 Low-energy-photon-emitting sources .13
4.4 Quantity to be measured .13
4.5 Reference and STANDARD TEST CONDITIONS .13
4.6 General test conditions.13
4.6.1 STANDARD TEST CONDITIONS.13
4.6.2 STABILIZATION TIME .13
4.6.3 Adjustments during test .14
4.6.4 Batteries.14
4.7 Constructional requirements as related to performance .14
4.7.1 General .14
4.7.2 Components .14
4.7.3 Display .14
4.7.4 Inserts .14
4.7.5 STABILIZATION TIME .14
4.8 Test of components.15
5 Limits of performance characteristics.15
5.1 Position of source in insert and repeatability .15
5.2 USABLE LENGTH .15
5.3 RESOLUTION OF THE DISPLAY .15
5.4 STABILIZATION TIME.15
5.5 LEAKAGE CURRENT.16
5.5.1 In AIR KERMA STRENGTH measuring mode.16
5.5.2 In charge measuring mode .16
5.6 Stability .16
5.6.1 Long term stability .16
5.6.2 MANUFACTURER method to check long term stability .16
6 LIMITS OF VARIATION for effects of influence quantities .16
6.1 General .16
6.2 IONIZATION CHAMBER – recombination losses .17
6.3 Operating voltage.17
6.3.1 Mains operated MEASURING ASSEMBLY .17
6.3.2 Battery operated MEASURING ASSEMBLY .17
6.3.3 Rechargeable MEASURING ASSEMBLY.18
6.4 Air pressure.18
6.5 Change of air pressure and EQUILIBRATION TIME of the radiation detector .18
62467-1 © IEC:2009 – 3 –
6.5.1 VENTED WELL TYPE IONIZATION CHAMBERS .18
6.5.2 SEALED WELL TYPE IONIZATION CHAMBERS.19
6.6 Temperature and humidity.19
6.7 Length RESPONSE .19
6.8 Electromagnetic immunity.20
7 Marking .20
7.1 WELL-TYPE IONIZATION CHAMBER ASSEMBLY.20
7.2 MEASURING ASSEMBLY .20
8 ACCOMPANYING DOCUMENTS.20
8.1 General .20
8.2 Use of t
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