Sterilization of health care products. Radiation - Requirements for the development, validation and routine control of a sterilization process for medical devices

What does BS EN ISO 11137-1:2026 - Requirements for development, validation and routine control of a sterilization process for medical devices cover?

1. the radionuclide 60Co or 137Cs;
2. a beam from an electron generator; or
3. x-rays from an x-ray generator.

Why should you use BS EN ISO 11137-1:2026 - Requirements for development, validation and routine control of a sterilization process for medical devices?

• Compliance: BS EN ISO 11137-1:2026 supplies a state-of-the-art means to validate and control a radiation sterilization process that meets international regulatory requirements.
• Quality assurance: it provides a framework that manufacturers can use to assure global customers that their devices consistently undergo a recognized and effective radiation sterilization process.
• Safety: since maintaining a high standard of sterility is key to preventing infections, BS EN ISO 37111:2024 plays a crucial role in ensuring patient safety and the effectiveness of medical devices.
• Contemporary: it aligns with current practices and the industry's commitment to evolving technologies and methodologies.
• Alignment: it aligns with the broader framework of quality management systems for medical devices production, reinforcing the principle that certain processes, like sterilization, require validation, routine monitoring and maintenance.
• Consistency: it contributes to the overall reliability and reproducibility of sterilization processes in the production of medical devices.
• Cost effectiveness: it helps manufacturers avoid the costs and time of developing their own protocols, and reduces the likelihood of errors, rework and costly recalls.
• Simplification: it includes guidance that helps manufacturers navigate complicated international regulatory requirements.
• Efficacy: the updated content in BS EN ISO 11137-1:2026 ensures the standard remains current and effective at tackling the challenges of radiation sterilization of healthcare products.

What has changed?

BS EN ISO 11137-1:2026 cancels and replaces BS ISO 11137-1:2006 as part of the standard's routine maintenance. The main changes compared to the previous edition are as follows: 

• addition of BS ISO 13004 as a normative reference;
• addition of BS ISO/ASTM 52628 standard practice for dosimetry in radiation
• processing as a normative reference and alignment of terminology across the
• document to ASTM standards terminology;
• replacement of Clause 4 with the updated common Clause 4 for BS ISO/TC 198 documents;
• increase of the allowable limits above which the potential induced radioactivity shall
• be assessed to 11 MeV for electrons and 7.5 MeV for X-rays;
• addition of a requirement to ensure that failure of a control function does not lead to a failure in recording process parameters such that an ineffective process appears effective;
• simplification of content on transference of verification dose or sterilization dose based on published data that demonstrates that differences in operating conditions of the two radiation sources have no effect on microbicidal effectiveness for product that does not support microbial growth;
• the use of dose measurements and the recording of process variables for process control has been clarified;
• clarification has been provided on the allowable interval of time for quarterly dose audits, allowing for an interval of four months provided there are four dose audits per year;
• addition of references for all VDmaxSD dose levels contained in both BS ISO 11137-2 and BS ISO 13004;
• additional information has been included on bioburden determination for product with very low bioburden;
  addition of guidance related to new or modified normative content.