IEC 62083:2009

Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

IEC 62083:2009 applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems:
- for use in radiotherapy treatment planning in human medical practice;
- that imports data either through input by the operator or directly from other devices;
- that outputs data either in printed form for review or directly to other devices;
and which is intended to be:
a) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training;
b) maintained in accordance with the recommendations given in the instructions for use, and
c) used within the environmental and electrical supply conditions specified in the technical description.
This second edition replaces the first edition of IEC 62083, published in 2000. This edition constitutes a technical revision, which brings this standard in line with changes to the other standards referred to in this standard.

Appareils électromédicaux - Exigences de sécurité pour les systèmes de planification de traitement en radiothérapie

La CEI 62083:2009 s'applique à la conception, à la fabrication ainsi qu'à certains aspects de l'installation des systèmes de planification de traitement en radiothérapie:
- qui sont utilisés en médecine humaine pour la planification des traitements de radiothérapie;
- qui utilisent des données entrées par l'opérateur ou importées directement depuis d'autres dispositifs;
- qui produisent des données de sortie qui sont soit imprimées pour être revues, soit exportées directement vers d'autres dispositifs;
et qui sont destinés à:
a) être utilisés en utilisation normale, sous la responsabilité de personnes qualifiées ou agréées à cet effet, par des opérateurs ayant les compétences et la formation nécessaires;
b) être entretenus selon les recommandations données dans les instructions d'utilisation, et
c) être utilisés dans les conditions d'environnement et d'alimentation électrique, spécifiées dans la description technique. La présente deuxième édition remplace la première édition de la CEI 62083 parue en 2000. Cette édition constitue une révision technique qui aligne la présente norme sur les modifications apportées aux autres normes auxquelles elle fait référence.

General Information

• Status: Published
• Publication Date: 22-Sep-2009
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 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: 31-Oct-2009
• Completion Date: 23-Sep-2009

Relations

• Revises: IEC 62083:2000 - Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 62083 ®
Edition 2.0 2009-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Requirements for the safety of radiotherapy
treatment planning systems
Appareils électromédicaux – Exigences de sécurité pour les systèmes de
planification de traitement en radiothérapie

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IEC 62083 ®
Edition 2.0 2009-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Requirements for the safety of radiotherapy
treatment planning systems
Appareils électromédicaux – Exigences de sécurité pour les systèmes de
planification de traitement en radiothérapie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
U
CODE PRIX
ICS 11.040.60 ISBN 978-2-88910-617-2
– 2 – 62083 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Normative references .7
3 Terms, definitions and abbreviations .8
3.1 Terms and definitions .8
3.2 Abbreviations .9
4 General .9
4.1 Development .9
4.2 Testing during installation.9
5 ACCOMPANYING DOCUMENTS.10
6 General requirements for operational safety .11
6.1 Distances and linear and angular dimensions .11
6.2 RADIATION quantities.11
6.3 Date and time format.11
6.4 Protection against unauthorized use.11
6.5 Data limits .12
6.6 Protection against unauthorized modification.12
6.7 Correctness of data transfer .13
6.8 Coordinate systems and scales .13
6.9 Saving and archiving data .13
7 RADIOTHERAPY TREATMENT EQUIPMENT MODELLING and BRACHYTHERAPY SOURCE
MODELLING .14
7.1 EQUIPMENT MODEL .14
7.2 BRACHYTHERAPY SOURCE MODEL .14
7.3 Dosimetric information.15
7.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptance .15
7.5 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL deletion.16
8 ANATOMY MODELLING .16
8.1 Data acquisition .16
8.2 Coordinate systems and scales .16
8.3 Contouring of regions of interest .17
8.4 PATIENT ANATOMY MODEL acceptance .17
8.5 PATIENT ANATOMY MODEL deletion.18
9 TREATMENT PLANNING .18
9.1 General requirements.18
9.2 TREATMENT PLAN preparation .18
9.3 TREATMENT PLAN identification .18
9.4 TREATMENT PLAN deletion.19
9.5 Electronic signatures .19
10 ABSORBED DOSE distribution calculation .19
10.1 Algorithms used .19
10.2 Accuracy of algorithms .19
11 TREATMENT PLAN report .20
11.1 Incomplete TREATMENT PLAN report .20

62083 © IEC:2009 – 3 –
11.2 Information on the TREATMENT PLAN report .20
11.3 Transmitted TREATMENT PLAN information.21
12 General hardware diagnostics .21
13 Data and code .22
14 Human errors in software design .22
15 Change in software versions.22
16 USE ERRORS.23
Annex A (normative) Hardware safety.24
Annex B (informative) Imported and exported data.26
Bibliography.27
Index of defined terms .28

Table 1 – Clauses and subclauses in this standard that require the provision of
information in the ACCOMPANYING DOCUMENTS and the technical description .10
Table A.1 – Table indicating correlation .24

– 4 – 62083 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY
TREATMENT PLANNING SYSTEMS
FOREWORD
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