Over deze norm
|Commissie||Medische elektrische toestellen|
This International Standard 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. This standard does not address dynamic beam deliveries. NOTE This may be addressed in a future version of this standard. It does, however, address certain specific aspects of the connection of the RVS to a network or to other radiotherapy equipment, and the communication protocol to be used.
|Nederlandse titel||Medische elektrische toestellen - Veiligheid van radiotherapiedossiers en onderzoeksystemen|
|Engelse titel||Medical electrical equipment - Safety of radiotherapy record and verify systems|