Ethylene oxide (EO) sterilization

EO sterilization validation ANSI, AAMI, ISO 11135, EN550

There is an inherit risk of product damage during sterilization due to excess moisture and/or possible temperature spikes during steam addition. It is the responsibility of the sponsor to assess this risk and determine the suitability of their product. NLI does not assume responsibility for this risk.

This study outline follows international and U.S. standards for ethylene oxide (EO) sterilization validations.

ISO (International Organization for Standardization) is a worldwide federation of national standards bodies.  The United States was one of the ISO members that took an active role in the development of ISO 11135 as a new ethylene oxide sterilization standard.

ISO 11135 was prepared by Technical Committee ISO/TC 198, Sterilization of Health Care Products.

Approved 7 February 1994 by AAMI, approved 24 March 1994 by the American National Standards Institute, Inc. as:

ANSI/AAMI/ISO 11135-1994 (Revision of ANSI/AAMI ST27-1988)

Note: This document is currently undergoing revision and will be merged with EN550.  Please contact the lab for details.

EO sterilization validation, on-site

On-site ethylene oxide sterilization.