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
Current Stage
6060 - Document made available - Publishing
Start Date
11-Dec-2009
Completion Date
11-Dec-2009

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 62083:2010
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
SIST EN 62083:2010 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 62083:2010

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SIST EN 62083:2010

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

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SIST EN 62083:2010
EN 62083:2009 - 2 -
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.
EN 62083:2009 constitutes a technical revision, which brings this standard in line with changes to the
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.
__________

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SIST EN 62083:2010
- 3 - EN 62083:2009
Annex ZA
(normative)

Normative references to international publications
...

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