scope:

This TIR addresses medical devices that are processed by ethylene oxide (EO) sterilization using conventional or parametric product release. The document applies to the following situations for the sterilization of medical devices:

a) a new product is being added to the previously validated process,

b) changes to validated products are being evaluated,

c) a previously validated process is being moved to a different facility or to different equipment, and

d) equivalency of a sterilization process is being evaluated.

Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.