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    Regulatory Landscape for EO Residue Levels in Medical Devices

    On-demand webinar

    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

    Register to view the on-demand webinar