ISO 10993-18: Medical Device Extractables Leachables (E&L) Testing Using Chemical Characterization
The materials used in medical devices don’t exist in isolation — they interact with the real world, with patients, and with substances like fluids, medications, and sterilants. Over time, these interactions can cause certain chemical compounds to migrate from device components into the body, potentially compromising patient safety.
We provide Extractables and Leachables (E&L) testing to help you identify and quantify those compounds — ensuring your device remains safe, compliant, and ready for market.
E&L Testing Capabilities
What Are Extractables and Leachables?
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Extractables are chemical compounds that can be forced out of a material when exposed to aggressive solvents or conditions (e.g., high temperature, prolonged exposure). These studies simulate worst-case scenarios and reveal the full range of compounds that could be released.
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Leachables are compounds that actually migrate from the material into a patient or surrounding environment during normal use. These are assessed under realistic conditions to evaluate long-term exposure risks.
Both types of data are essential for demonstrating the chemical safety of medical devices, as outlined in ISO 10993-18, which supports chemical characterization within a biological risk management framework.
Who Is E&L Testing For?
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Medical device manufacturers preparing for CE marking or FDA submission
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Developers of drug-device combination products
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Manufacturers of packaging or fluid-contact systems (e.g. tubing, syringes, catheters)
If your device contains polymers, adhesives, elastomers, coatings, or printing inks — E&L testing is a critical step in proving its biocompatibility.
Whether you’re early in development or nearing submission, Extractables and Leachables testing can be a turning point — helping you uncover risks, strengthen your data package, and reduce costly surprises.
We won’t keep you waiting
We respond to all enquiries within minutes of receiving them.
Our lead times match the urgency and demand in the market – we offer industry-leading turnaround times because we know how critical reliable data is for your project. While what you’ve seen is our typical lead time, the final timeline will depend on your specific study requirements. But rest assured, we’ll do everything we can to deliver even faster.
Think of it like a relay race – we’ll hand over the data baton as quickly as possible, so you can keep moving forward on your medical device journey.
