Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
|Publication Date:||1 January 2009|
This technical information report (TIR) provides guidance for selecting the appropriate type of microbial challenge to use in a sterilization validation process, the selection of appropriate inoculation sites, and the methods for inoculation and recovery of inoculated microorganisms from these sites.
The recommendations in this TIR are addressed to manufacturers of medical devices for sterilization validation testing and are not intended as guidance for routine or field testing of device sterilization.
This TIR does not cover microbial challenges or inoculation processes used for validation of cleaning or disinfection of medical devices.