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Valid from 05.07.2026

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This IEC 62083 2026 vs 2010 comparison helps manufacturers and regulatory teams quickly identify what has changed in the safety and design requirements for radiotherapy treatment planning systems. Our gap analysis breaks down clause-by-clause revisions, so your team can update technical documentation and validation processes without re-reading the entire standard. This standard, including type tests and site tests, applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system. It also covers the system's communication with other devices used in medical practice — including devices that import data (through operator input or from other devices) and those that output data to other devices. The standard applies where the system is intended for: Normal use, under the authority of appropriately qualified persons, by operators with the required skills and training Use and maintenance in accordance with the recommendations given in the instructions for use Operation within the environmental conditions specified in the technical description It also applies to any software application used for the development, evaluation, or approval of a treatment plan, whether stand-alone or part of another system. Whether you're updating a Design History File, preparing regulatory submissions, or responding to a notified body query, this IEC 62083 2026 vs 2010 report gives you a clear, audit-ready summary of exactly what's changed between the two revisions.