ISO 11137-1 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. This standard describes the requirements for ensuring that the activities associated with the process of radiation sterilization are performed properly. Although the scope is limited to medical devices, ISO 11137-1 can be applied to other products and equipment.
ISO 11137-1 covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs,
b) a beam from an electron generator or
c) a beam from an X-ray generator.
ISO 11137-1 cannot be applied to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
ISO 11137-1 does not:
— specify requirements for designating a medical device as sterile,
— specify a quality management system for the control of all stages of production of medical devices,
— require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release,
— specify requirements for occupational safety associated with the design and operation of irradiation facilities,
— specify requirements for the sterilization of used or reprocessed devices.
ISO 11137-1:2025 text has been approved in Europe as EN ISO 11137-1:2026 without any changes.
