ISO 11137‑1:2025 Explained | Key Radiation Sterilization Updates with Brian McEvoy
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Join Our Mailing ListStay ahead of regulatory and industry changes with STERIS as Brian McEvoy, Chief Technology Officer, walks you through the key updates in the 2025 revision of ISO 11137‑1, the international standard for radiation sterilization of healthcare products.
Whether you work in sterilization, quality assurance, regulatory affairs, or medical device manufacturing, this video will help you understand what’s new in ISO 11137‑1:2025 and how these revisions may influence your sterilization processes and compliance strategies.
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In this short overview, you’ll learn about the most significant changes impacting sterilization validation and routine control, including:
- New and updated normative references
- Expanded guidance for low bioburden determination
- Updated activation energy limits
- Clarification of the “dose is dose” principle
- How mathematical modeling and process‑variable measurements now support dose mapping
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