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    Specific to Ethylene Oxide, ISO11135:2014 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices) transition period has expired and is now fully in effect. In this Webinar, consultants will address the upcoming Amendment to Annex E, the methodology for Single Batch Release. Also reviewed will be relevant ISO committee activities and the status of ISO10993/7 (Biological evaluation of medical devices -- Ethylene oxide sterilization residuals), and emerging regulations relating to personnel exposure to EO.

    Specific to Radiation, subject matter experts will discuss the changes for ISO 11137-3:2017 (Sterilization of health care products – Radiation – Part3: Guidance on dosimetric aspects of development, validation and routine control), present a high-level overview of the much anticipated draft ISO/WD 11137 Part 4 (Guidance on control of the irradiation process) and review the increased security requirements for Irradiators (10CFR37 in U.S.).




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