AAMI has now issued TIR 56 providing guidance on EtO sterilization of medical devices using a flexible chamber system.
AAMI has recently issued TIR56 with the following title: “Guidance for development, validation, and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices”.
Validations of these systems have historically been done in line with ISO11135. However that standard is being revised and the new version, expected to be released later this year, will specifically exclude flexible chamber systems. Validations will therefore have to be done in line with ISO14937.
The release of this TIR will be very welcome to those companies currently using flexible chamber systems that were validated in line with ISO11135 and will now have to be validated in line with ISO14937. This document is complementary to the ISO Technical Specification entitled “Sterilization of health care products — Guidance on the application of ISO14937 to the sterilization of medical devices using Ethylene Oxide in a flexible sterilization chamber” that is currently under development.
A copy of the TIR may be purchased from the AAMI WebStore by clicking on the image on the left here.