This document updates a 2020 paper by the Irradiation Panel to reflect the April 2025 second edition of ISO 11137-1, focusing on normative requirements when changing radiation types (especially from gamma to X-ray) for sterilizing medical devices. The paper discusses and summarizes three key areas that must be evaluated during such changes: requirements for the radiation source, establishing or transferring the sterilization dose, and establishing or transferring the maximum acceptable dose along with Performance Qualification (PQ) dose mapping in the new irradiator.

