Publications

Change of Irradiation Modalities in Radiation Sterilization of Medical Devices – Normative Requirements and Aspects in EN ISO 11137-1

2020 / IRPN14-2020

This paper has been proposed by the X-ray Working Group of the Irradiation Panel in order to summarize normative requirements in EN ISO 11137-1 when changing of radiation sterilization modalities, especially from gamma to X-ray, for radiation sterilization of medical devices.

Discussion paperGammaISO 11137 GuidanceRadiation ProcessingX-ray