Publications

This publication highlights the key differences between the 2006 first edition and the 2025 second edition of ISO 11137-1, which covers requirements for developing, validating, and controlling radiation sterilization processes for medical devices. The document provides a general overview of significant technical changes between the two versions, excluding detailed discussion of the Annex updates. It is not meant to replace reading the actual standard or to offer additional guidance beyond identifying areas where the versions differ.