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

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

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1   Scope

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.