Publications

ISO 11137-2 is a standard that covers dose establishment requirements relating to radiation sterilization processing. The Microbiology Working Group of the Panel on Gamma and Electron Irradiation has summarised selected areas from ISO 11137-2 for clarification. The information below is the result of an analysis by the Microbiology Working Group based on their direct experiences of implementing the standard. The amount of information in ISO11137-2 is significant for anyone new to radiation sterilization processing. Whilst not written exclusively for the inexperienced, this overview has been compiled to assist those new to the field. Some insight into the rationale of dose establishment methods in the standard has therefore been included in this overview. There is an extensive bibliography at the end of ISO 11137-2 should more detail be required.