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

	Leonard Harris Senior Scientific Advisor Eurofins Medical Device Services
As a Senior Scientific Advisor at Eurofins Medical Device Services, Mr. Harris evaluates new technology and testing techniques for the medical device industry. This includes keeping abreast of industry trends as well as working to determine the impact of changes in regulations on the industry. With 25 years of industry experience in pharmaceuticals and medical device chemical testing, Mr. Harris is experienced in GMP and ISO test methods and validations, investigations, protocol validations, and data analysis. Mr. Harris holds a B.S. degree in chemistry from Shippensburg University.
	Danielle Anderson Sterilization Engineer IV Eurofins Medical Device Services
As Sterilization Engineer for Eurofins Medical Device Services, Ms. Anderson is responsible for sterilization validations performed at the Ethylene Oxide (EO) Sterilization site in San Jose. She oversees full validations, product adoptions, batch releases, comparative resistance studies, chamber equivalences, and bi-annual requalification. Ms. Anderson began her career with Eurofins as a sterilization operator, executing routine production and R&D sterilization cycles. She earned a B.S in biology from California State University Monterey Bay and is currently working towards her master’s in biology from Harvard University.