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Publications

Our publications have been developed and authored by Irradiation Panel officers and members.

They include guidance documents, reports, technical papers, and other resources that share the Panel’s expertise and support knowledge sharing and best practices across the irradiation industry.

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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

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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

ISO 11137-1 “Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices” : Note on differences between 2025 and 2006 versions

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ISO 11137-1 “Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices” : Note on differences between 2025 and 2006 versions

Release from an Electron Beam Irradiation Process Based on Irradiator Parameters (RBIP): Introductory Guidance

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Release from an Electron Beam Irradiation Process Based on Irradiator Parameters (RBIP): Introductory Guidance

Building a database of Sterilization Dose Audit positives to analyse trends seen across the industry

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Building a database of Sterilization Dose Audit positives to analyse trends seen across the industry

Guidance on the establishment of timeframes for testing associated with the requirements of ISO 11137, ISO 11737 and ISO 13004.

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Guidance on the establishment of timeframes for testing associated with the requirements of ISO 11137, ISO 11737 and ISO 13004.

Introduction and overview of methods for performance qualification (PQ) dose mapping based on ISO 11137-1 (ISO 2006).

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Introduction and overview of methods for performance qualification (PQ) dose mapping based on ISO 11137-1 (ISO 2006).