ISO 11137-1 Sterilization of Health Care Products - Radiation - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

ISO 11137-1 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. While the scope of ISO 11137-1 is limited to medical devices, it specifies requirements and provides guidance that can be applied to other products and equipment.

ISO 11137-1 covers radiation treatments using irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator, or a beam from an X-ray generator.

ISO 11137-1 does not specify requirements for the development, validation, and routine control of a process for inactivating agents that cause spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease.

This part of ISO 11137 does not require the use of biological indicators to verify or monitor radiation sterilization or a pharmacopoeial test for sterility for product release.

This part of ISO 11137 does not specify occupational safety requirements for the design and operation of irradiation facilities.

This part of ISO 11137 does not specify requirements for sterilization of used or reprocessed devices.

EUROLAB assists manufacturers with ISO 11137-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.