Ethylene Oxide (EO) At A Crossroads

Medical devices sterilised using Ethylene Oxide (EtO) gas must undergo residual testing to verify that any remaining sterilant or degradation by-products are within acceptable limits and do not present a toxicological risk to end users. Residual EtO levels can be influenced by a range of factors, including packaging configuration, component materials, sterilisation cycle parameters, and load density. As a result, determining when a product is safe for release can be complex.

Regulatory standards therefore, require that medical devices are not released until residual testing has been completed and compliance with allowable limits has been confirmed. Failure to provide documented evidence of testing can delay product launch timelines and disrupt manufacturing supply chains.

Eurofins Medical Device Testing offers comprehensive Ethylene Oxide Residuals Testing through its global network of laboratories, providing clients with a single source for both residual and sterility testing requirements. Our experienced team supports clients in meeting the requirements of the International Organization for Standardization ISO 10993-7 and has extensive expertise in Ethylene Oxide Residuals Testing for medical devices.

Clients benefit from direct communication with our laboratory teams, ensuring testing is performed efficiently and in accordance with the appropriate regulatory and industry standards.