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IEC 62667:2017

(Main)

Medical electrical equipment - Medical light ion beam equipment - Performance characteristics

Medical electrical equipment - Medical light ion beam equipment - Performance characteristics

IEC 62667:2017 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.

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.

General Information

Status
Published
Publication Date
22-Aug-2017
ICS
01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
11.040.60 - Therapy equipment
Technical Committee
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
Drafting Committee
WG 1 - TC 62/SC 62C/WG 1
Current Stage
PPUB - Publication issued
Start Date
16-Sep-2017
Completion Date
23-Aug-2017
Ref Project

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IEC 62667:2017 - Medical electrical equipment - Medical light ion beam equipment - Performance characteristicsIEC 62667:2017 - Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
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IEC 62667:2017 - Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
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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
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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

– 2 – IEC 62667:2017 © IEC 2017
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

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
...

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