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.