The Current Regulatory Landscape for EO Residue Levels in Medical Devices: What Manufacturers Need To Know Now, and What May Be on the Horizon
Download this whitepaper to learn the latest updates on European regulations and guidelines for residual ethylene oxide in medical devices.
Ethylene-oxide (EO) gas sterilization remains one of the most efficient and effective ways of deactivating bacteria and other potentially dangerous living microbes from critical plastic-based and heat-sensitive medical devices; however, manufacturers must take care to control and minimize ethylene-oxide residuals remaining in devices after sterilization has taken place.
The goal for medical-device manufacturers, then, is to minimize patient exposures to EO residues (and EO derivatives) from their devices during normal product use. Additionally, testing for ethylene-oxide residue on finished devices must be validated and the results documented by manufacturers per current regulations, particularly ISO 10993-7, in order to earn regulatory approval to market those devices.
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