ISO 11137: An overview of the process standard

Main components of ISO 11137

The standard describes procedures for development, validation and control of sterilization with ionizing radiation, for example through beta (E-Beam) or gamma rays. Methods for determining the required radiation dose and for checking the effectiveness and reproducibility of the process are specified. The standard also provides guidelines to ensure that sterilization does not impair the material properties or functionality of the medical devices. The standard consists of 4 parts:

ISO 11137-1

Part 1 of the standard specifies requirements for development, validation and control of the sterilization process and deals with:

• Validation: Proof that the process consistently achieves the required sterility assurance level (SAL). This includes microbiological, dosimetric and application validation.
• Process and quality control: Ensuring process stability through regular inprocess controls, calibrations and tests.
• Documentation: Detailed recording of all process steps for traceability and regulatory compliance.

ISO 11137-2

Part 2 describes the procedures for determining minimum radiation dose required to achieve the desired sterility assurance level (SAL). Various aspects are taken into account:

• Dose determination: Several methods are described to determine the required sterilization dose, e.g. using bioburden determinations.
• Dose confirmation: The established dose must be verified through further testing to ensure that the desired SAL is achieved and maintained.
• Definition of product families: Where applicable, products can be grouped into product families and validated. This is done with particular attention to the associated risks (e.g. different production sites).

ISO 11137-3

Dosimetry requirements are defined here in order to precisely measure and control the applied radiation dose:

• Dosimeter selection and calibration: Selection of suitable dosimeters and calibration procedures to ensure accurate measurements.
• Determination of the dose distribution: Determination of the dose distribution to identify areas with the lowest and the maximum radiation dose.
• Monitoring the radiation conditions: Continuous measurement and documentation of the radiation parameters to ensure a stable process.

ISO 11137-4

This part contains practical recommendations for process monitoring and control:

• Process monitoring: Methods for continuous monitoring of the sterilization process, including radiation monitoring and dosimetry testing.
• Quality management: Requirements for documentation, training and internal audits to ensure consistent process quality.
• Risk management: Strategies for identifying and minimizing potential risks, including contingency plans and corrective actions.

DIN EN ISO 11137 is the basis for quality assurance in radiation sterilization and contributes to the safety and effectiveness of medical devices. Compliance with this standard makes a decisive contribution to patient protection and to ensuring the highest standards in medical device technology.

Radiation sterilization as an outsourced process according to ISO 11137: What must manufacturers pay attention to?

Radiation sterilization is an essential process for the manufacture of safe medical devices and is subject to the requirements of DIN EN ISO 11137. Manufacturers of medical devices must ensure that sterilization is correctly validated, monitored and documented in order to meet regulatory requirements. The following points must be observed:

• Validation of the process: Proof that radiation sterilization reliably achieves the required dose range.
• Dose determination: Determining the minimum required radiation dose for reliable bioburden reduction without damaging the material, as well as determining the maximum permissible dose to ensure that the irradiated products remain fully functional.
• Dosimetry and monitoring: Continuous measurement and control of the applied radiation dose in the routine irradiation process.
• Material and packaging compatibility: Ensure that radiation sterilization does not adversely affect material properties and packaging integrity.
• Documentation and quality control: Seamless recording of all process steps for traceability and regulatory compliance.

By working closely with a specialist service provider for radiation sterilization, such as BGS, ensures efficient and standard-compliant sterilization . Early planning and regular communication with the external sterilization provider ensure a smooth process.

FAQ: Frequently asked questions about DIN EN ISO 11137

1. What types of radiation are covered by DIN EN ISO 11137?
   The standard covers gamma radiation, E-Beam and X-Ray for the sterilization of medical devices.
2. Where can the standard be viewed?
   DIN EN ISO 11137 is subject to a charge and can be purchased online from various providers (e.g. DIN MEDIA).
3. Does DIN EN ISO 11137 only apply to medical devices?
   Yes, the standard is primarily tailored to medical devices, but can serve as a guideline for other products as well.
4. When is revalidation of the sterilization process necessary?
   Revalidation is required in the event of changes to the product, the process or the environment, as well as in the event of abnormalities in microbiological tests. Regular inspections and new scientific findings may also require a reassessment.