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Medical electrical equipment - Safety of radiotherapy record and verify systems
STANDARD published on 27.5.2005
Designation standards: IEC 62274-ed.1.0
Publication date standards: 27.5.2005
SKU: NS-414406
The number of pages: 35
Approximate weight : 105 g (0.23 lbs)
Country: International technical standard
Category: Technical standards IEC
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. Sapplique a la conception et a la fabrication ainsi qua certains aspects dinstallation dun systeme denregistrement et de verification (SEV) utilise en radiotherapie dans la pratique medicale chez lhomme a) qui fournit, definit, ou affiche des donnees concernant la configuration des parametres de la machine de traitement; qui importe des donnees, soit par entrees de la part de loperateur, soit directement a partir dautres dispositifs, b) qui peut controler la capacite de fonctionnement de cet equipement; c) qui enregistre des donnees de toutes les seances de traitement; et d) qui est prevu: 1) pour une utilisation normale, sous lautorite de personnes qualifiees ou munies de la licence appropriee, par des operateurs possedant les competences et la formation necessaires; 2) pour etre entretenu conformement aux recommandations donnees dans les instructions dutilisation; et 3) pour etre utilise dans les conditions denvironnement et dalimentation electrique specifiees dans la description technique.
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