What is ISO/TS 11137-4 about?
ISO/TS 11137 discusses the process of radiation sterilization of health care products. ISO/TS 11137-4 outlines additional guidance to that given in ISO 111373 on meeting the requirements specified in ISO 111371, ISO 111372, and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation. This helps in the sterilization of health care products and monitoring an irradiation process using statistical techniques.
ISO/TS 11137-4 addresses the establishment of methods to set process target doses and verify the process is in a state of control. Dosimetry is used during the validation of a radiation sterilization process to measure doses, and the interpretation of dosimetry results from operational and performance qualification studies.
Who is ISO/TS 11137-4 for?
ISO/TS 11137-4 on radiation sterilization of health care products is useful for:
- Healthcare products manufacturers
- Test centres for health care products
- Regulatory authorities
Why should you use ISO/TS 11137-4?
The purpose of ISO/TS 11137-4 is to provide additional guidance on the establishment and control of the irradiation process, including setting process target doses and verifying that the process is in a state of control.
ISO/TS 11137-4 provides you with best practices and guidance on principles applied to validating, controlling an irradiation process, establishing process target doses, performance qualification outputs, routine monitoring and control, the release of product from the irradiation process, and maintaining process effectiveness for radiation sterilization of health care products.
This helps in the process control and meeting the requirements specified for minimum and maximum dose as outlined in ISO 11137-1, ISO 11137-2, and ISO/TS 13004.