08 April, 2025
New revision of ISO 11137-1:2025 published
A new revision of ISO 11137-1:2025 Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices has been released.
The 2025 edition of ISO 11137-1, which specifies the requirements for radiation sterilization of healthcare products, introduces several important updates:
- Expanded Normative References: ISO 13004 and ASTM 52628 have been added to the list of normative references, promoting greater consistency in terminology and validation methods across related standards.
- Higher Energy Limits: The allowable energy levels have been increased—from 10 MeV to 11 MeV for electron beams (E-Beam), and from 5 MeV to 7.5 MeV for X-rays—enabling deeper penetration and more effective sterilization of a wider range of product types and packaging.
- Simplified Dosimetry Requirements: The language around dosimetry has been clarified to remove the implication that it is required for every batch release. This change opens the door for parametric or machine-based release in facilities with adequate control systems.
- More Flexible Dose Audit Scheduling: The frequency of dose audits has shifted from every three months to every four months, as long as four audits are completed annually. This adjustment allows for improved scheduling flexibility and aligns with industry feedback.
- Additional VDmax Dose Options: The standard now recognizes VDmax doses in 2.5 kGy increments, as outlined in ISO 11137-2 and ISO 13004. This expansion supports lower dose options, helping reduce costs, increase throughput, and improve material compatibility
Overall, these changes enhance the standard’s adaptability, operational efficiency, and applicability across diverse sterilization scenarios.