ISO Certifications

All gamma and EO facilities are in compliance with FDA 21 CFR part 820 requirements, ISO 13485 registered, and AAMI/ANSI/ISO 11135-1:2007, AAMI/ANSI/ISO 11137-1:2006, and EN 550 compliant for product acceptance in U.S. and international markets.

Download the ISO certificate for all processing locations.

Contact Us
Contact a STERIS Isomedix Services representative to learn more about our gamma and ethylene oxide sterilization services.