1 Scope

This document, with the inclusion of type tests and site tests, applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system.

This document applies to the communication of the radiotherapy treatment planning system with other devices

• used in medical practice,

• that imports data either through input by the operator or from other devices,

• that outputs data to other devices, and

• that is intended to be

  • for normal use, under the authority of appropriately qualified persons, by operators having the required skills and training,

  • used and maintained in accordance with the recommendations given in the instructions for use, and

  • used within the environmental conditions specified in the technical description.

This document applies to any software application that is used for the development, evaluation, or approval of a treatment plan, whether stand-alone or part of another system.