White Paper: Medical

Regulatory Landscape for EO Residue Levels in Medical Devices

SPONSORED BY:

Ethylene oxide (EO) gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other potentially dangerous living microbes from medical devices; however, manufacturers must take care to control and minimize EO residuals remaining in devices after sterilization has taken place.

This white paper provides guidance on validating testing for EO residue on finished devices and documenting results per current regulations such as ISO 10993-7. Also highlighted are types of EO exposure, test methods and validation, and fugitive emissions.

Despite volumes of regulation devoted to residual EO and fugitive EO emissions, sterilization with this gas remains an excellent choice for critical, single-use medical devices to deactivate potentially dangerous microbes. The benefits of EO sterilization outweigh the drawbacks because of its effectiveness and its suitability for use with plastic and other heat-sensitive device materials.

Download this whitepaper to learn more.

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