DAY 3 - Toxicological Considerations of VH2O2 Sterilization Residuals

VH2O2 sterilization may leave hydrogen peroxide residuals on the device materials after the sterilization process whose toxicological risk must be evaluated (in addition to evaluating the device’s biocompatibility). ISO 22441 simply states that these limits shall be based on a health-based risk assessment per ISO 10993-17, which outlines expectations for the toxicological risk assessment of medical device constituents. This session will break down the required information for setting limits in hydrogen peroxide residual exposures, including consideration of the specific device’s intended use for the proper evaluation of devices for all intended patient populations and appropriate selection of test articles for evaluating multiple devices in a product family.
Attend this webinar and learn:
- What inputs are needed to assess toxicological risk of hydrogen peroxide residuals from vaporized hydrogen peroxide sterilization
- How to clearly outline worst-case device intended use
- How a device’s intended use factors affect test article selection and hydrogen peroxide residual limits