ISO 11137-1:2025 has officially been published, marking the first update since 2006. The changes are far-reaching and impactful, reflecting the evolving needs of the medical device industry—while also paving the way for broader use across industries like food, cannabis, and non-medical material modification.
Key Takeaways from the ISO 11137-1:2025 Update:
1. Expanded Normative References
ASTM 52628 has been added as a normative reference for dosimetry, along with informative references to other ASTM standards to clarify definitions related to dosimeter calibration. This change is intended to enhance harmonization and improve precision in sterilization validation processes. As a normative reference, radiation processors should be prepared to show compliance with ASTM 52628 as part of audits or inspections to ISO 11137-1, including a description of the dosimetry system used as well as evidence used to support dosimetry system calibration and analysis of influence quantities that are relevant to the dosimetry system being used.
2. Greater Industry Flexibility
References to ISO 13485 has been removed, opening the door for ISO 11137-1:2025 to be more readily used beyond the medical device industry. Non-medical industries such as food, cannabis, lab equipment, and others already use the concepts contained in the ISO 11137 series of standards. This change reduces the quality systems and regulatory burden for products that do not require a quality system used for medical device processing.
3. Raised Energy Limits
Energy thresholds have increased from 10 to 11 MeV for E-Beam and from 5 to 7.5 MeV for X-ray. Increased energy improves depth of penetration widening the range of products that can be effectively treated by irradiation (E-Beam/X-Ray), and improves throughput by allowing products to be treated in larger configurations. This could for example include treating individual boxes by shooting through a longer beam path, or treating products at pallet level that previously had to be depalletized and run as individual boxes.
4. Dosimetry Language Simplified
Language implying that dosimetry is required for batch release has been removed—allowing for the possibility of parametric or machine-based release, for facilities with sufficient integration between treatment control and monitoring systems.
5. More Flexible Dose Audit Schedules
The dose audit interval has shifted from every 3 months to every 4 months with 4 audits per year. This provides more flexibility for manufacturers and should help resolve a common and non-value added audit observation.
6. Support for More VDmax Dose Options
By incorporating VDmax doses from ISO 11137-2 and ISO 13004, the 2025 version officially supports VDmax doses in 2.5 kGy increments other than 15 and 25 kGy. While this was already possible with ISO/TS 13004, many auditors, notified bodies, and regulatory authorities did not recognize ISO/TS 13004. By incorporating the doses into ISO 11137-1, any uncertainty on the acceptance of the change should be resolved. For manufacturers, lower VDmax doses can boost throughput, lower costs, and improve material compatibility by allowing products to be assigned to doses lower than the historically common 25 kGy.
7. New Product Adoption Guidance
A dedicated section now outlines criteria for evaluating whether a product is a good fit for radiation sterilization, helping manufacturers make informed decisions earlier during product development and change control.
What Happens Next?
Various countries will undergo review and adoption of ISO 11137-1:2025 as a consensus standard. In the U.S. this is led by, AAMI Sterilization Working Group 02.As for FDA recognition, we don’t anticipate delays due to recent staffing changes, and we expect the process to move forward on normal timelines.
Supporting Your Transition
Whether you’re currently using radiation sterilization or exploring it as an alternative to ethylene oxide or steam, NextBeam can help you adapt to the new standard with:
- Expert-led validation support
- Flexible dose selection strategies
- Real-time dosimetry capabilities
- Guidance through regulatory transitions
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