Medical electrical equipment Safety of radiotherapy record and verify systems
|Publication Date:||1 May 2005|
|ICS Code (Therapy equipment):||11.040.60|
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.