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 chambers 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

Status
Published
Publication Date
09-Nov-2015
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
05-Nov-2015
Due Date
10-Jan-2016
Completion Date
10-Nov-2015

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SLOVENSKI STANDARD
SIST EN 62467-1:2015
01-december-2015
0HGLFLQVNDHOHNWULþQDRSUHPD'R]LPHWULþQLLQVWUXPHQWLNLVHXSRUDEOMDMRSUL
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
SIST EN 62467-1:2015 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 62467-1:2015
---------------------- Page: 2 ----------------------
SIST EN 62467-1:2015
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
---------------------- Page: 3 ----------------------
SIST EN 62467-1:2015
EN 62467-1:2015
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

EN 62467-1:2015.
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).
---------------------- Page: 4 ----------------------
SIST EN 62467-1:2015
EN 62467-1:2015
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)
---------------------- Page: 5 ----------------------
SIST EN 62467-1:2015
EN 62467-1:2015
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.
---------------------- Page: 6 ----------------------
SIST EN 62467-1:2015
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
CODE PRIX
ICS 11.040.50; 11.040.60 ISBN 978-2-88910-735-3
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN 62467-1:2015
– 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

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SIST EN 62467-1:2015
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

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SIST EN 62467-1:2015
– 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.

---------------------- Page: 10 ----------------------
SIST EN 62467-1:2015
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.
---------------------- Page: 11 ----------------------
SIST EN 62467-1:2015
– 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.
---------------------- Page: 12 ----------------------
SIST EN 62467-1:2015
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
---------------------- Page: 13 ----------------------
SIST EN 62467-1:2015
– 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

quotient of d ε by dm where d ε is the mean energy imparted by IONIZING RADIATION to water of

mass dm
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.

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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]
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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
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