Standards Development

Scope

This International Standard, with the inclusion of type tests and site tests, applies to the design, manufacture, installation, and maintenance of the software in a radiotherapy treatment planning system (rtps) as well as communication of the RTPS to other devices– in human medical practice;– that imports data either through input by the operator or from other devices;– that outputs data to other devices; and– which 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 standard applies to any software application that is used for the development, evaluation, or approval of a treatment plan, whether standalone or part of another system.NOTE Such software applications include prescribing systems, contouring systems, quality assurance systems, plan analysis systems, or plan review systems.