dnaSRPS EN IEC 62083:2025

Medical device software - Requirements for the safety of radiotherapy treatment planning systems

Scope

IEC 62083:2025, 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.

IEC 62083:2025 cancels and replaces the second edition published in 2009. This edition constitutes a technical revision.

This edition includes the following significant technical changes with respect to the previous edition:

– modification of the title from Medical electrical system - Requirements for the safety of radiotherapy treatment planning systems, to Medical device software - Requirements for the safety of radiotherapy treatment planning systems;

– Adaptive radiotherapy is added with Clause 16;

– The title reflects different implementations of radiotherapy treatment planning systems.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.