EN 62467-1:2015

SLOVENSKI STANDARD
01-december-2015
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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 the instrument .20
8.3 Documentation .21
Bibliography.22
Index of defined terms .23

Table 1 – REFERENCE and STANDARD TEST CONDITIONS.13
Table 2 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES.17

– 4 – 62467-1 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY –

Part 1: Instruments based on well-type ionization chambers

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 62467-1 has been prepared by subcommittee 62C, Equipment for
radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62,
Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/460/FDIS 62C/468/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

62467-1 © IEC:2009 – 5 –
A list of all parts of the IEC 62467 series, published under the general title Medical electrical
equipment – Dosimetric instruments as used in brachytherapy, can be found on the IEC
website.
In this standard the following print types are used: Requirements, compliance with which can
be tested, and definitions: in roman type;
– notes, explanations, advice, general statements and exceptions: in small roman type;
– test specifications: in italic type;
− TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN THE
PUBLICATIONS INDICATED IN THE INDEX OF DEFINED TERMS: IN SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 6 – 62467-1 © IEC:2009
INTRODUCTION
The wide range of WELL-TYPE IONIZATION CHAMBER instruments currently being used for
BRACHYTHERAPY sources indicates the need for a standard for uniformity in measurement and
test techniques for WELL-TYPE IONIZATION CHAMBER instruments. Measurements of the output of
BRACHYTHERAPY sources have distinct requirements that differ from the assay of sources used
in diagnostic nuclear medicine. This translates into the requirements for the measurement
devices. Many times similar instrumentation is used for both applications; however, there are
tighter requirements for those instruments used for BRACHYTHERAPY sources. Such devices
are composite systems consisting of an IONIZATION CHAMBER, either integrally coupled or
connected to appropriate electronic circuitry that converts the ionization current to a readout,
which can be converted to a quantity appropriate to the source being measured. The
ionization current produced can be either read directly or as accumulated charge (current
integrated over time) and then converted manually to the appropriate quantity, AIR KERMA
STRENGTH (REFERENCE AIR KERMA RATE) or ABSORBED DOSE TO WATER. The principles of
operation of the IONIZATION CHAMBER are well known and are not repeated here. In addition,
the readout device many times also has application to therapy uses and is well known.
Although this standard is written using the quantity AIR KERMA STRENGTH, the principles are the
same for other quantities such as REFERENCE AIR KERMA RATE.
In principle the quantity measured is the dose volume integral from which under specified
conditions the dose quantities AIR KERMA STRENGTH, REFERENCE AIR KERMA RATE, or ABSORBED
DOSE TO WATER at a depth can be deduced. The signal produced by the chamber is the
electrical current or charge, which is to be measured with an electrometer meeting criteria
according to IEC 60731. The current or charge is converted to the dosimetric quantity of
interest by means of a source type specific CALIBRATION FACTOR.

62467-1 © IEC:2009 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY –

Part 1: Instruments based on well-type ionization chambers

1 Scope and object
This part of IEC 62467 specifies the performance and some related constructional
WELL-TYPE IONIZATION CHAMBERS and associated measurement apparatus, as
requirements of
defined in Clause 3, 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.
This International Standard covers the techniques for the quantification of the quantity
BRACHYTHERAPY source under consideration. This quantity may be AIR
appropriate for the
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
WELL-
applications. The application of the standard is limited to instruments that incorporate
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 this standard 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.
This standard 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.
2 Normative references
The following referenced documents are indispensable for the application 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.
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 60580:2003, Medical electrical equipment – Dose area product meters

– 8 – 62467-1 © IEC:2009
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
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 equipment – Documentation
IEC 61674:1997, Medical electrical equipment – Dosimeters with ionization chambers and/or
semi-conductor detectors as used in X-ray diagnostic imaging
ISO/IEC Guide 99, International vocabulary of metrology – Basic and general concepts and
associated terms (VIM)
3 Terms and definitions
For the purposes of this document the following definitions apply.
The definitions given in this standard are generally in agreement with those in IEC/TR 60788
and ISO/IEC Guide 99 (IVM). Any term not defined in this clause or in the relevant
publications cited in the Index of defined terms has the meaning defined in IEC/TR 60788 and
ISO/IEC Guide 99 or is assumed to be in general scientific usage.
3.1
absorbed dose to water
D
quotient of d ε by dm where d ε is the mean energy imparted by IONIZING RADIATION to water of
mass dm
–1
NOTE 1 The unit of ABSORBED DOSE TO WATER is Gy (where 1 Gy = 1 J·kg ).
NOTE 2 This definition is derived from the definition in C.4 of ICRU 33 (see Bibliography).
[IEC 60731:1997, definition 3.26]
3.2
air kerma strength
product of AIR KERMA RATE in free space (in vacuo) due to photons greater than a low energy
cut off and the square of the distance of the calibration point from the source centre along the
perpendicular bisector
NOTE 1 Energy cut-off is generally 5 keV.
NOTE 2 The unit is Gy m /s.
NOTE 3 In practice the unit μGy m /h is used frequently.
3.3
chamber assembly leakage current
leakage current
any current in the signal path arising in the CHAMBER ASSEMBLY which is not produced by
ionization in the measuring volume
NOTE It is distinguished from ZERO DRIFT or ZERO SHIFT which arises in the MEASURING ASSEMBLY.

62467-1 © IEC:2009 – 9 –
3.4
correction factor
dimensionless multiplier which corrects the INDICATED VALUE of an instrument from its value
when operated under particular conditions to its value when operated under stated REFERENCE
CONDITIONS
[IEC 60731:1997, definition 3.6]
3.5
effective range
effective range of indicated values
range of INDICATED VALUES for which an instrument complies with a stated performance
NOTE 1 The maximum (minimum) EFFECTIVE INDICATED VALUE is the highest (lowest) in this range.
NOTE 2 The concept of EFFECTIVE RANGE may, for example, also be applied to scale readings and to related
quantities not directly indicated by the instrument e.g. input current.
[IEC 60731:1997, definition 3.15]
3.6
equilibration time
time taken for a scale reading to reach and remain within a specified deviation from its final
steady value after a sudden change in an INFLUENCE QUANTITY has been applied to the
instrument
[IEC 60731:1997, definition 3.12.3]
3.7
error of measurement
difference remaining between the MEASURED VALUE of a quantity and the TRUE VALUE of that
quantity
[IEC 60731:1997, definition 3.5.1]
3.8
indicated value
value of a quantity derived from the scale reading of an instrument together with any scale
factors indicated on the control panel of the instrument
[IEC 60731:1997, definition 3.2]
3.9
influence quantity
any external quantity that may affect the performance of an instrument
[IEC 60731:1997, definition 3.7]
NOTE E.g. ambient temperature, radiation quality etc.
3.10
instrument parameter
any internal property of an instrument that may affect the performance of this instrument
[IEC 60731:1997, definition 3.8]

– 10 – 62467-1 © IEC:2009
3.11
measured value
best estimate of the TRUE VALUE of a quantity, being derived from the INDICATED VALUE of an
instrument together with the application of all relevant CORRECTION FACTORS and the
CALIBRATION FACTOR
[IEC 60731:1997, definition 3.5]
3.12
measuring assembly
device to measure the charge (or current) from the WELL-
TYPE IONIZATION CHAMBER and possibly convert it into a form suitable for the quantity to be
measured
3.13
overall uncertainty
uncertainty associated with the MEASURED VALUE
NOTE 1 I.e. representing the bounds within which the ERROR OF MEASUREMENT is estimated to lie.
[IEC 60731:1997, definition 3.5.2, modified]
NOTE 2 See also Clause 5.
3.14
reference air kerma rate
AIR KERMA RATE in free space (in vacuo) due to photons greater than a low energy cut off at
the distance of 1 m
NOTE 1 Energy cut-off is generally 5 keV.
NOTE 2 The unit is Gy/s.
NOTE 3 In practice the unit μGy/h is used frequently.
NOTE 4 The AIR KERMA STRENGTH is numerically identical to the REFERENCE AIR KERMA RATE.
3.15
reference conditions
conditions under which all influence quantities and INSTRUMENT PARAMETERS have their
REFERENCE VALUES
[IEC 60731:1997, definition 3.9.1]
3.16
reference point of a well-type chamber
point of maximum signal for a specified point source along the measuring length of a WELL-
TYPE IONIZATION CHAMBER
NOTE The term reference point is often referred to as "sweet spot".
3.17
reference value
particular value of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER chosen for the purpose
of reference
[IEC 60731:1997, definition 3.9, modified]
NOTE I.e. the value of an INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) at which the CORRECTION FACTOR for
dependence on that INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) is unity.

62467-1 © IEC:2009 – 11 –
3.18
response
quotient of the INDICATED VALUE divided by the
CONVENTIONAL TRUE VALUE of the REFERENCE AIR KERMA RATE (in 1 m distance from the source)
3.19
...