IEC 62083:2000 ED1

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

Scope

Applies to the design, manufacture and some installation aspects of an RTPS

- for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice;

- that imports data either through input by the OPERATOR or direct
from other devices;

- that outputs data either in printed form for review or direct 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 descriptions.

An RTPS is principally a software application, and the object of this standard is to establish the requirements for features, associated documentation, and testing of the software.