The final hurdle between product and market is often the highest one for many device developers. Residual ethylene oxide testing is full of uncertainty. What’s required? How long will it all take? At what stage of the process should a laboratory get involved? If it’s missed, performed too late, or carried out incorrectly, your device’s regulatory approval will be delayed.

Residual ethylene oxide testing is a critical step in device development. Upcoming revisions to ISO 10993-7 and heightened scrutiny from the EPA are making accuracy, clarity, and planning even more essential.

The Eurofins Medical Device Services network of laboratories delivers expert ethylene oxide residuals testing you can trust. With support across every step of the development process -from designing a suitable test protocol for your device, to executing ISO 10993-7-compliant testing, Eurofins Medical Device Testing experts  perform all testing with speed and precision.

Whether your device is surface contacting, implantable, or falls into a special category, Eurofins Medical Device Services ensures your ethylene oxide residual levels fall well within the required tolerable contact limits (TCLs), even as those thresholds become more stringent.

• 3-sample testing programmes designed for efficiency
• Clear guidance on material selection and test planning
• Fully compliant and scalable to your product type and risk classification
• Identification of ethylene oxide -holding materials that may delay release
• Support for annual validation and design/manufacturing changes
• Testing conducted under ISO 10993-7 standards

Eurofins Medical Device Services network of  laboratories isequipped to test a wide range of devices and material compositions, including complex medical device designs. With decades of experience and real-time access to a dedicated project manager, you will understand where your device’s ethylene oxide residuals may be retained, reduce your overall testing burden, and avoid unnecessary repeat cycles.

• Accelerated scheduling when planned early
• Custom-designed test protocols for complex devices
• Tailored reporting packages suitable for submission

Compressed timelines. Growing regulatory expectations. High stakes patient safety. Eurofins Medical Device Services understands the pressures and support both large and small device manufacturers faced with testing for ethylene oxide residuals. No matter the project size, Eurofins Medical Device Services’ focus is the same: clarity, consistency, and compliance. By starting testing early, you can:

• Avoid costly delays due to residual non-compliance
• Minimise test volume and cost through strategic material insights
• Reduce the need for rework by designing the right protocol upfront

At Eurofins Medical Device Services, we do more than test your device. We provide guidance, troubleshoot, and partner with you. When it comes to ethylene oxide residuals, testing correctly and accurately means everything.