Dosimetry requirements derived from the sterilization standards

The main standards for radiation sterilization, ISO 11137 and EN 552, rest the documentation for the properly executed sterilization process on dosimetry. Both standards describe general requirements to the dosimetry system: The dose measurements must be traceable to national standards, the uncertainty of the dose measurement and the environmental influences must be known. This paper discusses how to obtain and maintain traceability and how to document measurement uncertainty. The implications of these requirements in the process control of radiation sterilization are further discussed. Known and documented uncertainty limits of the dose measurements can be used to specify process control limits. This is also useful, for example, when dose setting experiments are carried out according to the methods described in ISO 11137, where product samples shall be irradiated within narrow limits.