Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

This International Standard applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems(RTPS) – for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice; – that imports data either through input by the OPERATOR or directly from other devices; – that outputs data either in printed form for review or directly to other devices; – and which is intended to be – for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training; – maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and – used within the environmental and electrical supply conditions SPECIFIED in the technical description