EN 62274:2005

Medical electrical equipment - Safety of radiotherapy record and verify systems

Applies to the design and manufacture and some installation aspects of a record and verify system (RVS) for use in radiotherapy in human medical practice that a) provides, defines, or displays treatment machine set up data; imports data either through input by the operator or directly from other devices, b) may control the ability of that equipment to operate; c) records data of all treatment sessions; and d) is intended to be: 1) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training; 2) maintained in accordance with the recommendations given in the instructions for use; and 3) used within the environmental and electrical supply conditions specified in the technical description.

Medizinische elektrische Geräte - Sicherheit von Aufzeichnungs- und Verifikationssystemen für die Strahlentherapie

Appareils électromédicaux - Sécurité des systèmes d'enregistrement et de vérification de radiothérapie

S'applique à la conception et à la fabrication ainsi qu'à certains aspects d'installation d'un système d'enregistrement et de vérification (SEV) utilisé en radiothérapie dans la pratique médicale chez l'homme a) qui fournit, définit, ou affiche des données concernant la configuration des paramètres de la machine de traitement; qui importe des données, soit par entrées de la part de l'opérateur, soit directement à partir d'autres dispositifs, b) qui peut contrôler la capacité de fonctionnement de cet équipement; c) qui enregistre des données de toutes les séances de traitement; et d) qui est prévu: 1) pour une utilisation normale, sous l'autorité de personnes qualifiées ou munies de la licence appropriée, par des opérateurs possédant les compétences et la formation nécessaires; 2) pour être entretenu conformément aux recommandations données dans les instructions d'utilisation; et 3) pour être utilisé dans les conditions d'environnement et d'alimentation électrique spécifiées dans la description technique.

Medicinska električna oprema – Varnost radioterapevtskih zapisovalno-preverjalnih sistemov (IEC 62274:2005)

General Information

• Status: Published
• Publication Date: 14-Jun-2005
• Withdrawal Date: 31-May-2008
• 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: 15-Jun-2005
• Completion Date: 15-Jun-2005
• Ref Project: SIST EN 62274:2006 - Medical electrical equipment - Safety of radiotherapy record and verify systems

Standards Content (Sample)

SLOVENSKI SIST EN 62274:2006
STANDARD
januar 2006
Medicinska električna oprema – Varnost radioterapevtskih zapisovalno-
preverjalnih sistemov (IEC 62274:2005)
(istoveten EN 62274:2005)
Medical electrical equipment - Safety of radiotherapy record and verify systems IEC
62274:2005)
ICS 11.040.50; 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 62274
NORME EUROPÉENNE
EUROPÄISCHE NORM June 2005
ICS 11.040.60
English version
Medical electrical equipment –
Safety of radiotherapy record and verify systems
(IEC 62274:2005)
Appareils électromédicaux –  Medizinische elektrische Geräte –
Sécurité des systèmes d'enregistrement Sicherheit von Aufzeichnungs-
et de vérification de radiothérapie und Verifikationssystemen
(CEI 62274:2005) für die Strahlentherapie
(IEC 62274:2005)
This European Standard was approved by CENELEC on 2005-06-01. 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, 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

© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 62274:2005 E
Foreword
The text of document 62C/381/FDIS, future edition 1 of IEC 62274, prepared by SC 62C "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry" des IEC TC 62 "Electrical equipment in
medical practice", was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC
as EN 62274 on 2005-06-01.
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) 2006-03-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2008-06-01
In this standard, the following print types are used:
- requirements proper: roman type;
- test specifications: italic type;
- notes and explanatory matter: small roman type;
- TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT ARE DEFINED IN CLAUSE 3, OR IN OTHER
STANDARDS: SMALL CAPITALS.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62274:2005 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 60601-1-6 NOTE Harmonized as EN 60601-1-6:2004 (not modified).
IEC 60601-2-11 NOTE Harmonized as EN 60601-2-11:1997 (not modified).
IEC 60601-2-17 NOTE Harmonized as EN 60601-2-17:2004 (not modified).
IEC 62083 NOTE Harmonized as EN 62083:2001 (not modified).
__________
- 3 - EN 62274:2005
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 Where 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 1988 Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
A1 1993
+ corr. July 1994
A2 1995
A13 1996
IEC 60601-1-2 2001 Medical electrical equipment EN 60601-1-2 2001
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic
compatibility - Requirements and tests

IEC 60601-1-4 1996 Medical electrical equipment EN 60601-1-4 1996
Part 1-4: General requirements for safety -
Collateral standard: Programmable
electrical medical systems
A1 1999 A1 1999
IEC 60601-2-29 1999 Part 2-29: Particular requirements for the EN 60601-2-29 1999
safety of radiotherapy simulators

IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60950-1 2001 Information technology equipment - Safety EN 60950-1 2001
(mod) Part 1: General requirements + corr. April 2004
+ A11 2004
IEC 61000-2-4 2002 Electromagnetic compatibility (EMC) EN 61000-2-4 2002
Part 2-4: Environment - Compatibility
levels in industrial plants for low-frequency
conducted disturbances
IEC 61217 1996 Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
NORME CEI
INTERNATIONALE
IEC
INTERNATIONAL
Première édition
STANDARD
First edition
2005-05
Appareils électromédicaux –
Sécurité des systèmes d'enregistrement
et de vérification de radiothérapie

Medical electrical equipment –
Safety of radiotherapy record
and verify systems
 IEC 2005 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 any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
CODE PRIX
Q
PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue

62274  IEC:2005 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9
1 Scope and object.11
1.1 Scope.11
1.2 Object .11
1.3 Relationship to other standards .13
2 Normative references .13
3 Terms and definitions .15
4 General requirements for tests .15
4.1 Testing during development .15
4.2 Testing during installation.15
5 ACCOMPANYING DOCUMENTS .15
6 Requirements for safety .17
6.1 RADIATION quantities .17
6.2 Date and time.17
6.3 Coordinate systems and scales .19
6.4 Protection against unauthorized use.19
6.5 Correctness of data transfer .21
6.6 Data acceptance .21
6.7 Deleting and editing data.21
6.8 Backing up data .21
6.9 Archiving data .23
7 TREATMENT machine set-up verification.23
7.1 Prevention of TREATMENT .23
7.2 Override .23
7.3 Transfer of prescribed TREATMENT data.23
7.4 Accompanying information .23
8 TREATMENT recording and reporting .25
9 Accuracy .25
10 Abnormal operation and fault conditions .25
10.1 General hardware diagnostics .25
10.2 Data and code.25
11 Human errors in software design .25
12 Change in software versions.27
13 Human errors in use .27

Annex A (normative) Hardware safety.29

Bibliography.33
Index of defined terms .35

Table 1 – Clauses and subclauses in this standard that require the provision of
information in the ACCOMPANYING DOCUMENTS and the technical description.17

62274  IEC:2005 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
SAFETY OF RADIOTHERAPY RECORD
AND VERIFY SYSTEMS
FOREWORD
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