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IEC 60601-2-11:2013

(Main)

Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

IEC 60601-2-11:2013 applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition. Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. It does not attempt to define the optimum performance requirements for a gamma beam therapy equipment for use in radiotherapy. Its purpose is to identify those features of design which are regarded at the present time as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance at which it can be presumed that a fault condition applies, e.g. a component failure, and where an interlock then operates to prevent continued operation. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

Appareils électromédicaux - Partie 2-11: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de gammathérapie

La CEI 60601-2-11:2013 s'applique à la sécurité de base et aux performances essentielles des appareils de gammathérapie, y compris les appareils de radiothérapie stéréotaxique multi-sources. La présente norme particulière, partie de la série 60601, définit des exigences que les fabricants sont tenus de respecter dans la conception et la construction des appareils de gammathérapie. Elle indique les limites de tolérance au-delà desquelles des verrouillages doivent empêcher, interrompre ou terminer l'irradiation de manière à éviter une situation dangereuse. Les essais de type effectués par le fabricant ou les essais sur le site qui ne sont pas nécessairement effectués par le fabricant, sont spécifiés pour chacune des exigences. Cette Norme ne vise pas à définir des exigences de performances optimales pour les appareils de gammathérapie utilisés en radiothérapie. Il a pour objet d'identifier les caractéristiques de conception reconnues actuellement comme essentielles pour la sécurité de fonctionnement de tels appareils. Il fixe des limites de détérioration des performances des appareils, auxquelles il peut être présumé qu'une condition de défaut existe, par exemple, la défaillance d'un composant, et pour laquelle un verrouillage entre alors en action pour arrêter le fonctionnement. Cette troisième édition annule et remplace la deuxième édition de la CEI 60601-2-11 parue en 1997 et l'amendement 1:2004. La présente édition constitue une révision technique qui met la présente norme en conformité avec la troisième édition de la CEI 60601-1 et ses normes collatérales.

General Information

Status
Published
Publication Date
15-Jan-2013
ICS
01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
11.040.60 - Therapy equipment
Technical Committee
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
Drafting Committee
WG 1 - TC 62/SC 62C/WG 1
Current Stage
PPUB - Publication issued
Start Date
31-Jan-2013
Completion Date
16-Jan-2013
Ref Project

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IEC 60601-2-11:2013 - Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipmentIEC 60601-2-11:2013 - Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
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IEC 60601-2-11:2013 - Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
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IEC 60601-2-11
®

Edition 3.0 2013-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE


Medical electrical equipment –
Part 2-11: Particular requirements for the basic safety and essential performance
of gamma beam therapy equipment

Appareils électromédicaux –
Partie 2-11: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de gammathérapie


IEC 60601-2-11:2013

---------------------- Page: 1 ----------------------
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IEC 60601-2-11

®


Edition 3.0 2013-01




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Medical e
...

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