EN 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.

Medizinische elektrische Geräte — Festlegungen für die Sicherheit von Bestrahlungsplanungssystemen

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.

Medicinska električna oprema - Zahteve za varnost sistemov za načrtovanje radioterapevtske obravnave (IEC 62083:2009)

Ta evropski standard velja za načrtovanje, proizvodnjo in nekatere vidike nameščanja sistemov za načrtovanje radioterapevtske obravnave(RTPS)
- za uporabo pri NAČRTOVANJU RADIOTERAPEVTSKE OBRAVNAVE v človeških medicinski praksi;
- ki uvažajo podatke bodisi skozi vnos OPERATERJA ali neposredno skozi druge naprave;
- ki podajajo izhodne podatke bodisi v tiskani obliki za pregled ali naravnost v druge naprave;
- in ki so namenjeni
- OBIČAJNI UPORABI pod pristojnostjo primerno registrirane ali KVALIFICIRANE OSEBE s strani
OPERATERJEV, ki imajo potrebne veščine in usposabljanje;
- ki so vzdrževani v skladu s priporočili, podanimi v NAVODILIH ZA
UPORABO in
- ki se uporabljajo v okviru okoljskih pogojev in pogojev in preskrbo z elektriko, NAVEDENIH v tehničnem opisu.

General Information

• Status: Published
• Publication Date: 10-Dec-2009
• Withdrawal Date: 31-Oct-2012
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 11-Dec-2009
• Completion Date: 11-Dec-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 62083:2010 - Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009)

Relations

• Replaces: EN 62083:2001 - Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
• Effective Date: 29-Jan-2023
• Revised: prEN IEC 62083:2024 - Medical device software - Requirements for the safety of radiotherapy treatment planning systems
• Effective Date: 05-Feb-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2010
1DGRPHãþD
SIST EN 62083:2002
0HGLFLQVNDHOHNWULþQDRSUHPD=DKWHYH]DYDUQRVWVLVWHPRY]DQDþUWRYDQMH
UDGLRWHUDSHYWVNHREUDYQDYH,(&
Medical electrical equipment - Requirements for the safety of radiotherapy treatment
planning systems (IEC 62083:2009)
Medizinische elektrische Geräte - Festlegungen für die Sicherheit von
Bestrahlungsplanungssystemen (IEC 62083:2009)
Appareils électromédicaux - Règles particulières de sécurité pour les systèmes de
planification de traitement en radiothérapie (CEI 62083:2009)
Ta slovenski standard je istoveten z: EN 62083:2009
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 62083
NORME EUROPÉENNE
December 2009
EUROPÄISCHE NORM
ICS 11.040.60 Supersedes EN 62083:2001

English version
Medical electrical equipment -
Requirements for the safety of radiotherapy treatment planning systems
(IEC 62083:2009)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Exigences de sécurité Festlegungen für die Sicherheit
pour les systèmes de planification von Bestrahlungsplanungssystemen
de traitement en radiothérapie (IEC 62083:2009)
(CEI 62083:2009)
This European Standard was approved by CENELEC on 2009-11-01. 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, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels

© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62083:2009 E
Foreword
The text of document 62C/473/FDIS, future edition 2 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 2009-11-01.
This European Standard supersedes EN 62083:2001.
other standards referred to in this standard.
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) 2010-08-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-11-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– explanations, advice, general statements, exceptions and notes: in small roman type;
– test specifications: in italic type;
– TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED TERMS AND
CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS.
DEFINED IN
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62083:2009 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 62083:2009
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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.

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

IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic safety
and essential performance
1) 2)
IEC 60601-1-2 - Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-2-1 2009 Medical electrical equipment - - -
Part 2-1: Particular requirements for the basic
safety and essential performance of electron
accelerators in the range 1 MeV to 50 MeV

IEC 60601-2-11 1997 Medical electrical equipment - EN 60601-2-11 1997
Part 2-11: Particular requirements for the
safety of gamma beam therapy equipment

IEC/TR 60788 2004 Medical electrical equipment - - -
Glossary of defined terms
1) 2)
IEC 60950-1 (mod) - Information technology equipment - Safety - EN 60950-1 2006
Part 1: General requirements + A11 2009

1) 2)
IEC 61000-4-1 - Electromagnetic compatibility (EMC) - EN 61000-4-1 2007
Part 4-1: Testing and measurement
techniques - Overview of IEC 61000-4 series

1) 2)
IEC 61000-4-2 - Electromagnetic compatibility (EMC) - EN 61000-4-2 2009
Part 4-2: Testing and measurement
techniques - Electrostatic discharge immunity
test
1) 2)
IEC 61000-4-3 - Electromagnetic compatibility (EMC) - EN 61000-4-3 2006
Part 4-3: Testing and measurement
techniques - Radiated, radio-frequency,
electromagnetic field immunity test

1) 2)
IEC 61000-4-4 - Electromagnetic compatibility (EMC) - EN 61000-4-4 2004
Part 4-4: Testing and measurement
techniques - Electrical fast transient/burst
immunity test
1) 2)
IEC 61217 - Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
1) 2)
IEC 62304 - Medical device software - Software life-cycle EN 62304 2006
processes + corr. November 2008

1)
Undated reference.
2)
Valid edition at date of issue.

Publication Year Title EN/HD Year

IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices

ICRU Report 42 1987 Use of Computers in External Beam - -
Radiotherapy Procedures with High Energy
Photons and Electrons
- 5 - EN 62083:2009
Annex ZZ
(informative)
Coverage of Essential Requirements of EC 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 as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
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 2-8318-1062-2
– 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 .
...