New EU harmonized standard update for sterilization of health care products

The Commission Implementing Decision (EU) 2026/2481 updates the list of harmonized standards supporting compliance with the IVDR by publishing the reference of the revised standard EN ISO 11137-1:2026 on radiation sterilization of health care products.

Key takeaways:

• Publication of the new harmonized standard EN ISO 11137-1:2026, covering requirements for the development, validation, and routine control of radiation sterilization processes for medical devices.
• EN ISO 11137-1:2026 supersedes the previous EN ISO 11137-1:2015 and its amendment A2:2019, whose references will remain applicable during the transitional period until 10 May 2028.

The decision reflects the latest technical and scientific developments and reinforces the framework supporting conformity with the requirements of the IVDR.

DOWNLOAD THE DECISION EU 2026/2481