SIST EN IEC 62667:2018
(Main)Medical electrical equipment - Medical light ion beam equipment - Performance characteristics (IEC 62667:2017)
Medical electrical equipment - Medical light ion beam equipment - Performance characteristics (IEC 62667:2017)
This document applies to LIGHT ION BEAM ME EQUIPMENT when used, for therapy purposes, in
human medical practice.
This document applies to LIGHT ION BEAM ME EQUIPMENT which delivers LIGHT ION BEAMS with an
ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n.
This document describes measurements and test procedures to be performed by the
MANUFACTURER of LIGHT ION BEAM ME EQUIPMENT but does not specify ACCEPTANCE TESTS.
This document specifies test procedures for the determination and disclosure of performance
characteristics, knowledge of which is necessary for proper selection, application, and use of
LIGHT ION BEAM ME EQUIPMENT and which are to be declared in the ACCOMPANYING
DOCUMENTATION together with the greatest deviation or variation to be expected under specific
conditions in NORMAL USE. A format for presentation of performance values is given in
Annex A.
It is recognized that inaccuracies in the test methods can occur when assessing performance.
However, it was felt preferable not to combine the errors into an overall performance
tolerance but rather to keep them separate in the expectation that more accurate test methods
will evolve.
It is not intended that this document in any way inhibit the future development of new designs
of equipment which may have operating modes and parameters different from those described
herein, provided that such equipment achieves equivalent or better levels of performance for
the TREATMENT of PATIENTS.
This document applies to both ISOCENTRIC and non-ISOCENTRIC GANTRIES but many of the tests
assume that the LIGHT ION BEAM ME EQUIPMENT has an ISOCENTRIC GANTRY. Where the
equipment is non-ISOCENTRIC, the description of performance and test methods may be
suitably adapted.
Medizinische elektrische Geräte - Medizinische Leichtionen-Bestrahlungseinrichtungen - Leistungsmerkmale
Appareils électromédicaux - Appareils médicaux par faisceau d'ions légers - Caractéristiques de performances
L'IEC 62667:2017 s'applique aux appareils EM par faisceau d'ions légers utilisés dans la pratique médicale humaine à des fins de thérapie.
Le présent document s'applique aux appareils EM par faisceau d'ions légers qui produisent des faisceau d'ions légers avec une énergie par nucléon dans la plage comprise entre 10 MeV/n et 500 MeV/n.
Le présent document spécifie les mesurages et les procédures d'essai que le fabricant des appareils EM par faisceau d'ions légers doit réaliser. Elle ne définit pas en revanche d'essais d'acceptation.
Le présent document définit des procédures d'essai pour la détermination et la communication des caractéristiques de performances, dont la connaissance est nécessaire pour le choix, l'application et l'utilisation corrects des appareils EM par faisceau d'ions légers. Ces procédures doivent être déclarées dans les documentations d'accompagnement, ainsi que l'écart ou la variation maximal(e) à prévoir dans des conditions d'utilisation normale spécifiques. Un format de présentation des valeurs de performances est fourni à l'Annexe A.
Medicinska električna oprema - Medicinska oprema s šibkim ionskim žarkom - Tehnične lastnosti (IEC 62667:2017)
Ta dokument velja za ELEKTROMEDICINSKO OPREMO S ŠIBKIM IONSKIM ŽARKOM, če se oprema uporablja za zdravljenje ljudi.
Ta dokument velja za ELEKTROMEDICINSKO OPREMO S ŠIBKIM IONSKIM ŽARKOM, ki sprošča ŠIBKE IONSKE ŽARKE z ENERGIJO NA NUKLEON v razponu od 10 MeV/n do 500 MeV/n.
Ta dokument opisuje meritve in preskusne postopke, ki jih mora opraviti PROIZVAJALEC ELEKTROMEDICINSKE OPREME S ŠIBKIM IONSKIM ŽARKOM, vendar ne določa PRESKUSOV SPREJEMLJIVOSTI.
Ta dokument določa preskusne postopke za ugotavljanje in navajanje delovnih karakteristik, ki jih je treba poznati za pravilno izbiro, apliciranje in uporabo ELEKTROMEDICINSKE OPREME S ŠIBKIM IONSKIM ŽARKOM in ki jih je treba navesti v PRILOŽENI DOKUMENTACIJI skupaj z največjimi odstopanji ali spremembami, ki jih je mogoče pričakovati pod določenimi pogoji pri OBIČAJNI UPORABI. Format za predstavitev vrednosti lastnosti je podan v dodatku A.
Ugotovljeno je, da lahko pri ocenjevanju delovanja pride do netočnosti v preskusni metodi. Vendar se je zdelo bolje, da napake niso združene v skupna odstopanja v delovanju, ampak ostanejo ločene, saj se pričakuje razvoj bolj točnih preskusnih metod.
Namen tega dokumenta ni, da bi na kakršen koli način oviral prihodnji razvoj nove opreme, ki bo lahko imela drugačne načine delovanja in parametre, kot so opisani v tem dokumentu, pod pogojem da takšna oprema dosega enakovredno ali boljšo raven učinkovitosti za ZDRAVLJENJE BOLNIKOV.
Ta dokument velja tako za IZOCENTRIČNE kot za ne-IZOCENTRIČNE NOSILCE, vendar številni testi predpostavljajo, da ima ELEKTROMEDICINSKA OPREMA S ŠIBKIM IONSKIM ŽARKOM IZOCENTRIČNI NOSILEC. Če oprema ni IZOCENTRIČNA, je lahko opis delovanja in preskusnih metod ustrezno prilagojen.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 62667:2018
01-julij-2018
0HGLFLQVNDHOHNWULþQDRSUHPD0HGLFLQVNDRSUHPDVãLENLPLRQVNLPåDUNRP
7HKQLþQHODVWQRVWL ,(&
Medical electrical equipment - Medical light ion beam equipment - Performance
characteristics (IEC 62667:2017)
Ta slovenski standard je istoveten z: EN IEC 62667:2018
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN IEC 62667:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 62667:2018
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SIST EN IEC 62667:2018
EUROPEAN STANDARD EN IEC 62667
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2018
ICS 11.040.60
English Version
Medical electrical equipment - Medical light ion beam equipment
- Performance characteristics
(IEC 62667:2017)
Appareils électromédicaux - Appareils médicaux par Medizinische elektrische Geräte - Medizinische Leichtionen-
faisceau d'ions légers - Caractéristiques de performances Bestrahlungseinrichtungen - Leistungsmerkmale
(IEC 62667:2017) (IEC 62667:2017)
This European Standard was approved by CENELEC on 2017-09-27. 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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 62667:2018 E
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SIST EN IEC 62667:2018
EN IEC 62667:2018 (E)
European foreword
The text of document 62C/693/FDIS, future IEC 62667, 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 IEC 62667:2018.
The following dates are fixed:
(dop) 2018-10-20
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2021-04-20
• 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 shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 62667:2017 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 60601-2-11:2013 NOTE Harmonized as EN 60601-2-11:2015.
IEC 60601-2-17:2013 NOTE Harmonized as EN 60601-2-17:2015.
IEC 60601-2-68:2014 NOTE Harmonized as EN 60601-2-68:2015.
IEC 60731:2011 NOTE Harmonized as EN 60731:2012.
IEC 60976:2007 NOTE Harmonized as EN 60976:2007.
IEC 61223-3-5:2004 NOTE Harmonized as EN 61223-3-5:2004.
IEC 61267:2005 NOTE Harmonized as EN 61267:2006.
IEC 62083:2009 NOTE Harmonized as EN 62083:2009.
IEC 62220-1-1:2015 NOTE Harmonized as EN 62220-1-1:2015.
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015.
2
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EN IEC 62667:2018 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
NOTE 1 Where 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 60580 2000 Medical electrical equipment - Dose EN 60580 2000
area product meters
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety
and essential performance
+A1 2012 +A1 2013
IEC 60601-2-1 2009 Medical electrical equipment - Part 2- EN 60601-2-1 2015
1: Particular requirements for the
basic safety and essential
performance of electron accelerators
in the range 1 MeV to 50 MeV
+A1 2014 - -
IEC 60601-2-64 2014 Medical electrical equipment -- Part 2- EN 60601-2-64 2015
64: Particular requirements for the
basic safety and essential
performance of light ion beam medical
equipment
IEC 61217 2011 Radiotherapy equipment - EN 61217 2012
Coordinates, movements and scales
IEC/TR 60788 2004 Medical electrical equipment - - -
Glossary of defined terms
3
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SIST EN IEC 62667:2018
IEC 62667
®
Edition 1.0 2017-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment – Medical light ion beam equipment – Performance
characteristics
Appareils électromédicaux – Appareils médicaux par faisceau d'ions légers –
Caractéristiques de performances
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-4734-1
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 62667:2018
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CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 10
4 Environmental conditions . 17
4.1 General . 17
4.2 Transport and storage . 18
4.3 Facility stability . 18
5 Presentation of information to the USER . 18
5.1 General . 18
5.2 Intended parameters . 18
6 Beam delivery . 18
6.1 LIGHT ION species . 18
6.2 Energy . 18
6.2.1 Method of selection of ENERGY PER NUCLEON or LIGHT ION BEAM RANGE . 18
6.2.2 Range of available ENERGIES PER NUCLEON or LIGHT ION BEAM RANGES . 18
6.2.3 Methods of ensuring the ENERGY PER NUCLEON OR LIGHT ION BEAM RANGE . 19
6.2.4 Accuracy of ENERGY PER NUCLEON or LIGHT ION BEAM RANGE . 19
6.3 BEAM GATING . 19
6.3.1 Method of BEAM GATING . 19
6.3.2 BEAM GATING required input trigger . 19
6.4 GANTRIES . 19
6.4.1 GANTRY types . 19
6.4.2 GANTRY configurations . 19
6.4.3 GANTRY angle readout . 20
6.5 APPLICATOR CARRIAGE . 20
6.6 LIGHT ION BEAM APPLICATORS . 20
6.7 Adjustable BEAM LIMITING DEVICES (BLDS) . 20
6.7.1 Information to the USER . 20
6.7.2 Test . 21
6.8 ISOCENTRE . 21
6.8.1 Information to the USER . 21
6.8.2 Test . 22
6.9 LATERAL SPREADING DEVICES (LSDs) . 22
6.9.1 Type and order of lateral SPREADING DEVICES in the RADIATION HEAD . 22
6.9.2 SCANNING MODES for laterally spreading the beam . 23
6.9.3 UNIFORM SCANNING . 23
6.9.4 Synchronization types for scanning the beam . 23
6.9.5 VIRTUAL SOURCE-TO-AXIS DISTANCES (VSADS) . 23
6.10 Time constraints . 24
6.10.1 General . 24
6.10.2 Maximum IRRADIATION TIME . 24
6.10.3 Time to switch between IRRADIATIONS in different rooms . 24
6.10.4 Time to switch beam between RADIATION HEADS with a common ERP . 25
6.10.5 Time to switch between two ENERGY PER NUCLEON levels . 25
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6.10.6 Time to switch between two LIGHT ION species . 25
6.10.7 Time to TERMINATE and INTERRUPT IRRADIATION . 26
6.10.8 Time to restart IRRADIATION . 26
6.10.9 Start-up time . 26
6.10.10 Time for shutdown . 26
6.11 Maintenance . 27
7 DOSE MONITORING SYSTEM . 27
7.1 General . 27
7.2 Standard test conditions for testing DOSE MONITORING SYSTEMS . 27
7.3 Reproducibility of MU delivery . 27
7.3.1 Information to the USER . 27
7.3.2 Test . 27
7.4 Proportionality of MU delivery . 28
7.4.1 Requirement . 28
7.4.2 Information to the USER . 29
7.4.3 Test . 29
7.5 Off-axis response of beam FLUX monitor for MODULATED SCANNING . 30
7.5.1 Information to the USER . 30
7.5.2 Test . 30
7.6 Dependence of MU delivery on angular position . 31
7.6.1 Information to the USER . 31
7.6.2 Test . 31
7.7 Stability of MU DELIVERY . 32
7.7.1 Stability of MU DELIVERY throughout the day . 32
7.7.2 Stability of MU DELIVERY throughout the week . 33
8 DEPTH DOSE characteristics . 34
8.1 DEPTH DOSE distributions for NON-RANGE MODULATED PORTALS . 34
8.1.1 Information to the USER . 34
8.1.2 Test . 34
8.2 Range modulating techniques . 35
8.2.1 Type and sequence of range MODULATION DEVICES in RADIATION HEAD . 35
8.2.2 Discrete RANGE MODULATION DEVICE . 35
8.2.3 Programmable RANGE MODULATION DEVICE . 35
8.3 RANGE MODULATED PORTAL DEPTH DOSE distributions . 36
8.3.1 Information to the USER . 36
8.3.2 Test . 36
8.4 Stability OF LIGHT ION BEAM RANGE . 37
8.4.1 Stability of LIGHT ION BEAM RANGE throughout an IRRADIATION . 37
8.4.2 Dependence of LIGHT ION BEAM RANGE on GANTRY rotation . 37
9 Lateral profiles of LIGHT ION PORTALS . 38
9.1 Lateral profiles of LIGHT ION PORTALS for systems that use scatterers or
UNIFORM SCANNING . 38
9.1.1 General . 38
9.1.2 Flatness of LIGHT ION PORTALS . 39
9.1.3 Symmetry of LIGHT ION PORTALS. 39
9.1.4 Lateral PENUMBRA . 40
9.2 Lateral profiles of LIGHT ION PORTALS for systems that use MODULATED
SCANNING . 40
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9.2.1 Information to the USER . 40
9.2.2 Test . 40
10 LIGHT ION PORTAL with energy and FLUENCE modulation (EFM) . 41
10.1 Information to the USER . 41
10.2 Beam characteristics and dosimetry system performance for small delivered
doses . 41
11 Time to irradiate SPECIFIED volumes . 41
11.1 Information to the USER . 41
11.2 Test . 42
12 Indication of RADIATION FIELDS . 42
12.1 APPLICATOR CARRIAGE extension indicator. 42
12.1.1 Information to the USER . 42
12.1.2 Test . 42
12.2 Multi-element BLD element position indications . 42
12.2.1 Information to the USER . 42
12.2.2 Test . 42
12.3 Indication of THE LIGHT ION REFERENCE AXIS . 43
12.3.1 General . 43
12.3.2 Indication on entry to the PATIENT . 43
12.3.3 Indication of the LIGHT ION REFERENCE AXIS on distal side of PATIENT . 44
12.4 LIGHT FIELD-indicator . 44
12.4.1 Information to USER . 44
12.4.2 Test . 44
13 PATIENT SUPPORTS . 45
13.1 General . 45
13.2 TABLE TOPS . 45
13.2.1 General . 45
13.2.2 Available TABLE TOPS . 45
13.2.3 Extent of movements of TABLE TOP relative to PATIENT SUPPORT . 45
13.2.4 Positional deviation of the TABLE TOP surface during longitudinal motion . 46
13.2.5 Positional deviation of the TABLE TOP surface during lateral motion . 47
13.3 Coordinate system . 48
13.4 Extent of movements for PATIENT SUPPORT . 48
13.4.1 Information to the USER . 48
13.4.2 ISOCENTRIC rotation of THE PATIENT SUPPORT . 48
13.4.3 Accuracy of PATIENT SUPPORT translational motions . 48
13.4.4 Accuracy of PATIENT SUPPORT rotational motions . 49
Annex A (informative) Format for presentation of performances values . 54
Bibliography . 115
Index of defined terms . 116
Figure 1 – Explanatory diagram for parameters associated with a non-range
modulated LIGHT ION BEAM . 50
Figure 2 – Explanatory diagram for parameters associated with a DEPTH DOSE
distribution of LIGHT ION BEAM RANGE MODULATED PORTALS (left − protons, right − carbon
ions) . 50
Figure 3 – The rotational GANTRY . 51
Figure 4 – Depths to measure lateral profiles . 52
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Figure 5 – Example of profile of ABSORBED DOSE along the major axes . 52
Figure 6 – Flattened area . 53
Table 1 – Standard test conditions for testing reproducibility . 28
Table 2 – Conditions for testing proportionality of the DOSE MONITORING SYSTEM . 30
Table 3 – Conditions for testing off-axis response of the beam FLUX monitor for
MODULATED SCANNING . 31
Table 4 – Conditions for testing dependence of the DOSE MONITORING SYSTEM on
angular position . 32
Table 5 – Conditions for testing stability throughout the day of the DOSE MONITORING
SYSTEM. 33
Table 6 – Conditions for testing stability throughout the week of the DOSE MONITORING
SYSTEM. 34
Table 7 – Conditions for testing stability of LIGHT ION BEAM RANGE during an IRRADIATION . 37
Table 8 – Conditions for testing dependence of the LIGHT ION BEAM RANGE on GANTRY
angle . 38
Table 9 – Conditions for testing the indication on entry to the PATIENT . 43
Table 10 – Conditions for testing positional and pitch deviation of the TABLE TOP
surface during longitudinal motion relative to the PATIENT SUPPORT base . 46
Table 11 – Conditions for testing positional deviation of the TABLE TOP surface during
lateral motion relative to PATIENT SUPPORT base . 47
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
MEDICAL LIGHT ION BEAM EQUIPMENT –
PERFORMANCE CHARACTERISTICS
FOREWORD
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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 62667 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/6
...
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