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Webinar

Regulatory Landscape for EO Residue Levels in Medical Devices

0 h 30 min

The global regulatory landscape around Ethylene Oxide (EO) residues is a topic of increasing interest. This webinar provides an overview of EO sterilization and the status of ISO standard 10993-7:2008, which serves as an international authoritative document for medical device manufacturers. The session covers topics such as testing according to product category and use, concomitant EO exposure, topical contact, and special situations like intraocular lenses and cardiopulmonary bypass devices.

Participants will learn about the test methods and validation processes for EO residues, the ISO 10993-7 revision for products intended for neonates and children, and the recommendations by ANSM (the French Regulator). The webinar also addresses the monitoring of fugitive EO emissions throughout the supply chain to safeguard worker exposure.

By understanding the regulatory requirements and best practices for managing EO residues, professionals involved in sterilization, quality assurance, and regulatory compliance can enhance their EO sterilization protocols. This knowledge will help them ensure that their products are safe, effective, and compliant with regulatory standards. The webinar provides practical guidance on navigating the complexities of EO residues and implementing effective monitoring and validation strategies.

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