White Paper about the current rational dose distribution (as of 2021)
White Paper: How to perform dose distribution measurements
The performance of dose distribution mapping serves (in addition to the microbiological establishing of the sterilization dose) the development and validation of radiation sterilization. The aim here is to demonstrate that the required sterilization dose is achieved and that the maximum acceptable (without compromising safety, quality or performance) dose is not exceeded.
Before performing a dose distribution measurement, both the required sterilization dose and the maximum acceptable dose must be determined and specified. Furthermore, the packing configuration of the products within the product carton and irradiation container must be determined.
The requirements and procedures are described in various ISO/ASTM/and AAMI standards. In our opinion, the three most important are ISO 11137-1, ISO 11137-3 and AAMI TIR29.