We read the standard (and explain in medium form) so you don’t have to.
The ISO 11137 standard is an internationally recognized set of guidelines for the sterilization of healthcare products using radiation. It ensures that medical devices are consistently sterile, safe, and effective at scale.
- How to develop and validate a sterilization process (ISO 11137-1).
- How to determine and verify the correct sterilization dose (ISO 11137-2).
- How to measure and control radiation doses accurately (ISO 11137-3).
- How to establish and control processes for radiation sterilization (ISO 11137-4).
1. ISO 11137-1:2006 – Development, Validation, and Routine Control of a Radiation Sterilization Process
This section outlines the requirements for ensuring that medical devices sterilized by radiation remain safe and effective. Key aspects include:
- Sterilizing Agents: Covers gamma radiation (from Cobalt-60 or Cesium-137), electron beam, and X-ray sterilization.
- Process Validation: Establishes protocols for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Routine Monitoring: Describes procedures for ongoing control, including dose monitoring and recalibration.
- Quality System Requirements: Aligns with ISO 13485 (medical device quality management systems).
- Microbicidal Effectiveness & Product Considerations: Addresses how different materials respond to radiation and environmental impacts.
2. ISO 11137-2:2013 – Establishing the Sterilization Dose
This section focuses on methods to determine the minimum dose needed to achieve sterility, including:
- Dose Determination Methods:
- Method 1: Uses bioburden information to set sterilization doses based on microbial resistance.
- Method 2: Uses a statistical model (fraction positive) to extrapolate sterilization doses.
- VDmax Method: Validates preselected doses (e.g., 25 kGy or 15 kGy) using microbiological testing.
- Sterilization Dose Audits: Ensures that the established dose remains effective through periodic validation.
- Product Family Definition: Establishes criteria for grouping products based on bioburden characteristics.
3. ISO 11137-3:2017 – Guidance on Dosimetric Aspects
This section provides guidance on radiation dose measurement (dosimetry), including:
- Dosimetry Systems: Requirements for calibrating and validating dose measurement instruments.
- Dose Mapping: Techniques for assessing dose distribution in products during sterilization.
- Uncertainty Analysis: Evaluating measurement uncertainties in sterilization doses.
- Operational & Performance Qualification: Establishes detailed steps for dose testing across different irradiation methods (gamma, e-beam, X-ray).
4. ISO 11137-4:2020 – Guidance on Process Control
This section provides additional guidance on establishing and maintaining process control for radiation sterilization. Key aspects include:
- Process Target Doses: Describes specific doses set at monitoring locations to ensure that the sterilization process consistently delivers the required minimum dose without exceeding the maximum acceptable dose.
- Statistical Process Control (SPC): Emphasizes the application of SPC techniques to monitor and maintain the irradiation process in a state of control.
- Process Variability and Measurement Uncertainty: Addresses sources of variation in the sterilization process, including factors related to the irradiation equipment, product loading configurations, and dosimetry systems.
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Whether you’re developing a new sterilization process or optimizing an existing one, NextBeam ensures your products meet the highest standards for safety and reliability. Book a 1:1 call with a sterilization expert, instantly.
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