AAMI TIR56-2013
Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices

Standard No.

AAMI TIR56-2013

Release Date

2013

Published By

US-AAMI

Latest

AAMI TIR56-2013

Scope

This AAMI Technical Information Report (TIR) provides information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas diffusion within individually sealed flexible sterilization bags.

AAMI TIR56-2013 history

• 2013 AAMI TIR56-2013 Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices