EN 62083:2001
(Main)Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Applies to the design, manufacture and some installation aspects of an RTPS - for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice; - that imports data either through input by the OPERATOR or direct from other devices; - that outputs data either in printed form for review or direct to other devices; - and which is intended to be . for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training; . maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and . used within the environmental and electrical supply conditions SPECIFIED in the technical descriptions. An RTPS is principally a software application, and the object of this standard is to establish the requirements for features, associated documentation, and testing of the software.
Medizinische elektrische Geräte - Festlegungen für die Sicherheit von Bestrahlungsplanungssystemen
Appareils électromédicaux - Règles particulières de sécurité pour les systèmes de planification de traitement en radiothérapie
S'applique à la conception, à la fabrication ainsi qu'à certains aspects de l'installation des SPTR - qui sont utilisés en médecine humaine pour la PLANIFICATION DES TRAITEMENTS de RADIOTHERAPIE; - qui utilisent des données entrées par l'OPERATEUR 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 . être utilisés en UTILISATION NORMALE, sous la responsabilité de PERSONNES QUALIFIEES ou agréées à cet effet, par des OPERATEURS ayant les compétences et la formation nécessaires; . être entretenus conformément aux recommandations données dans les INSTRUCTIONS D'UTILISATION, et . être utilisés selon les conditions d'environnement et d'alimentation électrique SPECIFIEES dans la description technique. Un SPTR est principalement une application logicielle, et la présente norme a pour objet d'établir des prescriptions pour les caractéristiques, pour la documentation associée et pour les essais du logiciel.
Medical electrical equipment - Requirements for the safety of radiotheraphy treatment planning systems (IEC 62083:2000)
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SLOVENSKI SIST EN 62083:2002
prva izdaja
STANDARD
junij 2002
Medical electrical equipment - Requirements for the safety of radiotheraphy
treatment planning systems (IEC 62083:2000)
ICS 11.040.60 Referenčna številka
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
EUROPEAN STANDARD EN 62083
NORME EUROPÉENNE
EUROPÄISCHE NORM February 2001
ICS 11.040.60
English version
Medical electrical equipment
Requirements for the safety of radiotherapy treatment planning systems
(IEC 62083:2000)
Appareils électromédicaux Medizinische elektrische Geräte
Règles particulières de sécurité Festlegungen für die Sicherheit von
pour les systèmes de planification de Bestrahlungsplanungssystemen
traitement en radiothérapie (IEC 62083:2000)
(CEI 62083:2000)
This European Standard was approved by CENELEC on 2000-12-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland and United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62083:2001 E
Foreword
The text of document 62C/280/FDIS, future edition 1 of IEC 62083, 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 was approved by CENELEC
as EN 62083 on 2000-12-01
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2001-09-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2003-12-01
NOTE In this standard, the following print types are used:
- requirement: in roman type;
- test specifications: in italic type;
- notes: in smaller roman type.
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annexes A, C and ZA are normative and annex B is informative.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62083:2000 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60601-2-1 NOTE: Harmonized as en 60601-2-1:1998 (not modified).
__________
- 3 - EN 62083:2001
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
1) 2)
IEC 60601-1 Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety
1) 2)
IEC 60601-1-2 Medical electrical equipment EN 60601-1-2 1993
2)
Part 1: General requirements for safety -- + corr. December 1997
2. Collateral standard: Electromagnetic
compatibility - Requirements and tests
1) 2)
IEC 60601-1-4 Medical electrical equipment EN 60601-1-4 1996
Part 1-4: General requirements for safety
-- Collateral standard: Programmable
electrical medical systems
1) 2)
IEC 60788 Medical radiology - Terminology HD 501 S1 1988
1) 2)
IEC 60950 (mod) Safety of information technology EN 60950 2000
equipment
1) 2)
IEC 61000-4-1 Electromagnetic compatibility (EMC) EN 61000-4-1 2000
Part 4-1: Testing and measurement
techniques - Overview of IEC 61000-4
series
1) 2)
IEC 61000-4-2 Part 4-2: Testing and measurement EN 61000-4-2 1995
techniques - Electrostatic discharge
immunity test
1) 2)
IEC 61000-4-3 Part 4-3: Testing and measurement
EN 61000-4-3 1996
(mod) techniques - Radiated, radio-frequency,
electromagnetic field immunity test
1) 2)
IEC 61000-4-4 Part 4-4: Testing and measurement EN 61000-4-4 1995
techniques - Electrical fast transient/burst
immunity test
1)
undated reference.
2)
valid edition at date of issue.
Publication Year Title EN/HD Year
1) 2)
IEC 61217 Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
ICRU rapport 42 1987 Use of Computers in External Beam --
Radiotherapy Procedures with high
Energy Photons and Electrons
NORME CEI
INTERNATIONALE IEC
INTERNATIONAL
Première édition
STANDARD
First edition
2000-11
Appareils électromédicaux –
Règles particulières de sécurité
pour les systèmes de planification
de traitement en radiothérapie
Medical electrical equipment –
Requirements for the safety of
radiotherapy treatment planning systems
IEC 2000 Droits de reproduction réservés Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
utilisée sous quelque forme que ce soit et par aucun procédé, any form or by any means, electronic or mechanical,
électronique ou mécanique, y compris la photocopie et les including photocopying and microfilm, without permission in
microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
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Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
U
PRICE CODE
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue
62083 © IEC:2000 – 3 –
CONTENTS
Page
FOREWORD . 7
INTRODUCTION . 11
Clause
1 Scope and object . 13
2 Normative references . 13
3 Relationship to other standards . 15
3.1 Hardware SAFETY standards . 15
3.2 Software SAFETY standards . 15
3.3 IEC 61217 Radiotherapy equipment – Coordinates, movements and scales . 15
4 Terminology and definitions. 15
5 General requirements for tests . 17
5.1 Testing during development . 17
5.2 Testing during installation. 17
6ACCOMPANYING DOCUMENTS. 19
7 General requirements for operational safety . 21
7.1 Distances and linear dimensions . 21
7.2 RADIATION quantities . 21
7.3 Date and time format. 21
7.4 Protection against unauthorized use . 21
7.5 Data limits. 23
7.6 Protection against unauthorized modification . 25
7.7 Correctness of data transfer. 25
7.8 Coordinate systems and scales . 25
7.9 Saving and archiving data . 25
8 RADIOTHERAPY TREATMENT EQUIPMENT and BRACHYTHERAPY SOURCE MODELLING. 27
8.1 General. 27
8.2 Dosimetric information . 29
8.3 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptance. 29
8.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL deletion . 31
9ANATOMY MODELLING . 31
9.1 Data acquisition . 31
9.2 Coordinate systems and scales . 31
9.3 Contouring of regions of interest. 33
9.4 PATIENT ANATOMY MODEL acceptance . 33
9.5 PATIENT ANATOMY MODEL deletion. 35
10 TREATMENT PLANNING. 35
10.1 General requirements. 35
REATMENT PLAN
10.2 T preparation . 35
10.3 TREATMENT PLAN identification . 37
10.4 TREATMENT PLAN deletion. 37
10.5 Electronic signatures. 37
62083 © IEC:2000 – 5 –
Clause Page
11 ABSORBED DOSE distribution calculation. 37
11.1 Algorithms used . 37
11.2 Accuracy of algorithms . 39
12 TREATMENT PLAN report. 41
12.1 Incomplete TREATMENT PLAN report . 41
12.2 Information on the TREATMENT PLAN report . 41
12.3 Transmitted TREATMENT PLAN information. 43
13 General hardware diagnostics . 43
14 Arithmetic processor . 43
15 Data and code. 43
16 Human errors in software design . 45
17 Change in software versions. 45
18 Human errors in use. 47
Annex A (normative) Hardware safety . 49
A.1 General requirements. 49
A.2 Completeness of hardware SAFETY . 51
A.3 Completeness of ACCOMPANYING DOCUMENTS . 51
Annex B (informative) Imported and exported data. 53
Annex C (normative) Terminology – Index of defined terms. 55
Bibliography . 59
Table 1 – Clauses and subclauses in this standard that require the provision of information
in the ACCOMPANYING DOCUMENTS and the technical description . 19
Table A.1 – Table indicating correlat
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