Practical Navigation of the Approaches Contained in ISO 11137-2 and ISO 13004

This presentation will provide a brief outline of the microbiological aspects of the validation process under the ISO 11137-2 and ISO 13004 standards for radiation sterilization. We will review the approaches contained in these standards with practical working examples of how various product requirements (such as minimum dose, maximum dose, and bioburden levels) drive the selection of the appropriate approach within the ISO standards.