The global regulatory landscape around Ethylene Oxide (EO) residues is a topic of increasing interest. This webinar will provide 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 in order to know how to set your company up for the future. The following topics will be covered:
- Testing according to product category and product use
- Concomitant EO exposure
- Topical contact
- Special situations (e.g., intra ocular lenses, cardiopulmonary bypass devices, …)
- Test method and validation
- ISO 10993-7 revision for products intended for neonates and children /recommendation by ANSM – French Regulator
- Fugitive EO emission from EO treated products, which must be monitored throughout the supply chain to safeguard worker exposure
- Legislation regarding EO emissions in the supply chain
