scope:

Parametric release is the declaration of adequacy of routine processing for a validated sterilization process based solely on measurement and documentation of physical process parameters rather than results of biological indicator or product sterility evaluation.

This technical information report (TIR) presents the rationale and approach necessary for the implementation of parametric release for product sterilized by ethylene oxide (EO). Additionally, this report highlights the importance and inter-relationship of other process factors (i.e., load configuration and equipment performance) that ultimately influence EO sterilization reproducibility.

Product adoption and process equivalency are not addressed in this document but will be addressed in a separate Association for the Advancement of Medical Instrumentation (AAMI) TIR.