EN 60601-2-29:2008

Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

IEC 60601-2-29:2008 establishes requirements to be complied with by manufacturers in the design and construction of radiotherapy simulators; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an interlock then operates to prevent continued operation of the medical electrical equipment. This third edition cancels and replaces the second edition published in 1999. This edition constitutes a technical revision, which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

Medizinische elektrische Geräte - Teil 2-29: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Strahlentherapiesimulatoren

Appareils électromédicaux - Partie 2-29: Exigences particulières pour la sécurité de base et les performances essentielles des simulateurs de radiothérapie

La CEI 60601-2-29:2008 décrit les exigences auxquelles les fabricants doivent se conformer lors de la conception et de la construction des simulateurs de radiothérapie; elle ne vise pas à définir des exigences de performances optimales. Son objet est d'identifier les caractéristiques de conception reconnues actuellement comme essentielles pour la sécurité de fonctionnement de tels appareils électromédicaux. Elle fixe des limites de détérioration des performances des appareils électromédicaux qui seraient la conséquence d'une condition de défaut, telle que la défaillance d'un composant, pour lesquelles un verrouillage doit entrer en action pour empêcher l'appareil électromédical de continuer à fonctionner. Cette troisième édition annule et remplace la deuxième édition parue en 1999, dont elle constitue une révision technique, qui représente un alignement de cette norme avec la troisième édition de la CEI 60601-1 et ses normes collatérales.

Medicinska električna oprema - 2-29. del: Posebne zahteve za osnovno varnost in bistvene lastnosti radioterapevtskih simulatorjev (IEC 60601-2-29:2008)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI RADIOTERAPEVTSKIH SIMULATORJEV, v nadaljevanju ME OPREMA. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda.

General Information

• Status: Published
• Publication Date: 27-Nov-2008
• Withdrawal Date: 31-Oct-2011
• 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: 28-Nov-2008
• Completion Date: 28-Nov-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-29:2009 - Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008)

Relations

• Replaces: EN 60601-2-29:1999 - Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators
• Effective Date: 29-Jan-2023
• Amended By: EN 60601-2-29:2008/A11:2011 - Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-29:2009
01-februar-2009
1DGRPHãþD
SIST EN 60601-2-29:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUDGLRWHUDSHYWVNLKVLPXODWRUMHY,(&
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and
essential performance of radiotherapy simulators (IEC 60601-2-29:2008)
Medizinische elektrische Geräte - Teil 2-29: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Strahlentherapiesimulatoren
(IEC 60601-2-29:2008)
Appareils électromédicaux - Partie 2-29: Exigences particulières pour la sécurité de base
et performances essentielles des simulateurs de radiothérapie (CEI 60601-2-29:2008)
Ta slovenski standard je istoveten z: EN 60601-2-29:2008
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-29:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-2-29:2009

---------------------- Page: 2 ----------------------

SIST EN 60601-2-29:2009

EUROPEAN STANDARD
EN 60601-2-29

NORME EUROPÉENNE
November 2008
EUROPÄISCHE NORM

ICS 11.040.60 Supersedes EN 60601-2-29:1999


English version


Medical electrical equipment -
Part 2-29: Particular requirements for the basic safety and essential
performance of radiotherapy simulators
(IEC 60601-2-29:2008)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-29: Exigences particulières Teil 2-29: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des simulateurs de radiothérapie von Strahlentherapiesimulatoren
(CEI 60601-2-29:2008) (IEC 60601-2-29:2008)




This European Standard was approved by CENELEC on 2008-11-01. 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: rue de Stassart 35, B - 1050 Brussels


© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-29:2008 E

---------------------- Page: 3 ----------------------

SIST EN 60601-2-29:2009
EN 60601-2-29:2008 - 2 -
Foreword
The text of document 62C/423/CDV, future edition 3 of IEC 60601-2-29, 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 Unique Acceptance Procedure and was approved
by CENELEC as EN 60601-2-29 on 2008-11-01.
This European Standard supersedes EN 60601-2-29:1999.
EN 60601-2-29:2008 constitutes a technical revision, which brings EN 60601-2-29 in line with
EN 60601-1:2006 and its collateral standards.
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) 2009-08-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2011-11-01
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 93/42/EEC. See Annex ZZ.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
–
tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTE
...