ISO 11135:2014 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices) was originally published in August 2014. As the end of the 3-year transition period approaches, the specifications in the previous edition will no longer apply.
This Webinar will address the significant changes in the most recent edition, with a focus on the additional parameters that are required to be included in the routine sterilization process specification, plus the expanded guidance relating to re-qualification review.
Grégory Grams, Senior SteriPro Consultant EMEAA, Sterigenics
Mike Padilla, Manager, SteriPro Consulting, Sterigenics