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Change of type of radiation in Radiation Sterilization of Medical Devices – Normative Requirements and Aspects in EN ISO 11137-1:2025

2026 / IRPN23-2026

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.

Discussion paperElectron BeamGammaISO 11137 GuidanceMicrobiologyX-ray