Webinars: Medical

Regulatory Landscape for EO Residue Levels in Medical Devices



The global regulatory landscape around Ethylene Oxide (EO) residues is a topic of increasing interest.

This webinar will provide:

  • An overview of EO sterilization
  • The status of ISO standard 10993-7:2008, which serves as an international authoritative document for medical device manufacturers. The following topics will be covered:
    • Testing according to product category and product use
    • Concomitant EO exposure
    • Topical contact
    • Special product categories (intraocular lenses, blood oxygenators etc.)
    • Test method and validation
    • ISO 10993-7 revision for products intended for neonates and children /recomendation by ANSM – French Regulator
    • Fugitive EO emission from EO treated products must be monitored throughout the supply chain to safeguard minimum worker exposure.
    • Legislation regarding EO emissions in the supply chain will also be addressed.

An audience Q&A follows the live presentation.

Speaker:

Dr. Stefan Reisbacher, SteriPro Consultant, Sterigenics