Medical electrical equipment. Safety of radiotherapy record and verify systems

Medical electrical equipment. Safety of radiotherapy record and verify systems

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1   Scope and object

1.1   Scope

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
  1. a) provides, defines, or displays treatment machine set up data; imports data either through input by the operator or directly from other devices,
  2. b) may control the ability of that equipment to operate;
  3. c) records data of all treatment sessions; and
  4. d) is intended to be:
    1. 1) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training;
    2. 2) maintained in accordance with the recommendations given in the instructions for use; and
    3. 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.