IEC 60601-2-11-ed.3.0

Detail information

Designation: IEC 60601-2-11-ed.3.0

Publication date: 16/01/2013

Pages: 100

Country: International technical standard

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Anotation

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. La CEI 60601-2-11:2013 sapplique a la securite de base et aux performances essentielles des appareils de gammatherapie, y compris les appareils de radiotherapie stereotaxique multi-sources. La presente norme particuliere, partie de la serie 60601, definit des exigences que les fabricants sont tenus de respecter dans la conception et la construction des appareils de gammatherapie. Elle indique les limites de tolerance au-dela desquelles des verrouillages doivent empecher, interrompre ou terminer lirradiation de maniere a eviter une situation dangereuse. Les essais de type effectues par le fabricant ou les essais sur le site qui ne sont pas necessairement effectues par le fabricant, sont specifies pour chacune des exigences. Cette Norme ne vise pas a definir des exigences de performances optimales pour les appareils de gammatherapie utilises en radiotherapie. Il a pour objet didentifier les caracteristiques de conception reconnues actuellement comme essentielles pour la securite de fonctionnement de tels appareils. Il fixe des limites de deterioration des performances des appareils, auxquelles il peut etre presume quune condition de defaut existe, par exemple, la defaillance dun composant, et pour laquelle un verrouillage entre alors en action pour arreter le fonctionnement. Cette troisieme edition annule et remplace la deuxieme edition de la CEI 60601-2-11 parue en 1997 et lamendement 1:2004. La presente edition constitue une revision technique qui met la presente norme en conformite avec la troisieme edition de la CEI 60601-1 et ses normes collaterales.