Why choose this package?

This package provides the foundational requirements (Part 1), specific methods for establishing the sterilization dose (Part 2), essential guidance on accurate dose measurement (Part 3), and practical advice on process control (Part 4), offering a holistic approach from development to routine monitoring. 

• ISO 11137-1:2025 establishes the fundamental requirements for implementing and maintaining a validated radiation sterilization process for healthcare products.
• ISO 11137-2:2013 provides detailed methods (e.g., VDmax, Method 1/2) for determining the appropriate radiation dose to achieve the required Sterility Assurance Level (SAL).
• ISO 11137-3:2017 offers guidance on accurate radiation dose measurement, including dosimetry system selection, calibration, measurement uncertainty, and dose mapping.
• ISO/TS 11137-4:2020 provides practical guidance on controlling the radiation sterilization process, focusing on irradiator qualification, ongoing monitoring, and maintaining process effectiveness.

Key benefits

• Complete framework for radiation sterilization: Access an integrated set of documents covering the entire lifecycle of radiation sterilization process management.
• Facilitate global regulatory compliance: Streamline submissions and demonstrate adherence to internationally recognized best practices accepted by major regulatory bodies (e.g., FDA, EU MDR/IVDR notified bodies).
• Includes the latest foundational requirements (ISO 11137-1:2025): Ensure your processes align with the most current internationally agreed-upon requirements and expectations.
• Robust sterilization dose establishment & substantiation: Implement scientifically sound methods for determining and verifying the appropriate sterilization dose for your products.
• Enhanced dosimetric accuracy and control: Improve the reliability and accuracy of radiation dose measurements critical for process validation and routine monitoring.
• Practical guidance on process control: Gain actionable insights into maintaining consistent process effectiveness beyond dose measurement alone