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.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.