EO Sterilization at a Crossroads: Preparing for Stricter Residue Limits and Regulatory Shifts

Ethylene oxide (EO or EtO) remains the cornerstone of medical device sterilization, accounting for approximately 50% of all sterilized devices globally. Despite its unmatched efficacy for heat- and moisture-sensitive products, EO’s classification as a carcinogen and its association with neurological and reproductive risks have prompted decades of scrutiny. As scientific advancements are made, the regulatory landscape changes and we as an industry must evolve as well. As regulatory pressure intensifies, the industry faces a pivotal moment.

Join Eurofins experts to explore the evolving landscape of EO sterilization through the lens of regulatory changes, including the foundational standard guiding residual safety. With ISO 10993-7 undergoing reassessment using toxicological frameworks from ISO 10993-17, stakeholders must prepare for stricter residue limits and enhanced risk-based evaluations.

During this webinar you will learn:

Scientific and regulatory drivers behind EO reassessment
Key challenges in ISO 10993-7 and their practical implications
Changes to ISO 11135 and other regulations designed to reduce EO in sterilization cycles
Eurofins ability to support small scale sterilization needs