Extractables & Leachables (E&L) Testing

We provide chemical characterisation testing in accordance with ISO 10993 18, using extractables and leachables testing to identify and characterise chemical substances that may be released from medical devices throughout their intended life cycle.

Our Accreditations

ISO 10993-18: Medical Device Extractables Leachables (E&L) Testing Using Chemical Characterisation

Chemical characterisation testing in accordance with ISO 10993‑18 is performed by using extractables and leachables methodologies to identify and characterise chemical substances associated with a medical device.

Testing begins with selection of appropriate extraction conditions, including solvents, temperatures, and durations, designed to represent worst‑case and clinically relevant exposure scenarios across the device life cycle.

Device materials, components, or finished devices are then extracted and analysed using a range of analytical techniques (such as chromatographic and spectrometric methods) to detect and identify organic and inorganic compounds.

The resulting chemical profile is evaluated to determine which substances require further toxicological assessment, providing a robust, standard‑aligned data set to support ISO 10993‑17 risk assessment and the overall biological evaluation.

Testing strategies are tailored to the medical device and the resulting data provides meaningful outcomes that strengthen biological safety justifications and guide efficient testing strategies.

Identify extractable and leachable substances. Use extractables and leachables testing to generate a comprehensive chemical profile of substances that may migrate from the device under defined use and processing conditions.
Support toxicological risk assessment. Provide robust chemical characterisation data suitable for ISO 10993 17 toxicological evaluations, including establishment of margins of safety.
Strengthen biological safety justifications. Deliver standard aligned chemical data that supports biological risk assessments and overall device safety conclusions.
Inform efficient testing strategies. Use chemical characterisation results to guide the need for further biological testing, helping to avoid unnecessary studies while fully addressing chemical related risks.

E&L Testing Capabilities

Custom Extractables Study Design

We perform worst‑case extractables testing in accordance with ISO 10993‑18 to support robust chemical characterisation of medical devices.
Our studies are designed to identify chemical substances that could potentially be released from device materials under exhaustive or exaggerated conditions, providing a conservative assessment of chemical risk.
Testing is carried out using extraction conditions selected to represent worst‑case scenarios based on the device’s materials, manufacturing processes, sterilisation method, surface area, and intended clinical use.
This may include the use of multiple solvents of differing polarity, elevated temperatures, extended extraction durations, and high surface‑area‑to‑volume ratios to maximise substance release.
The resulting extracts are analysed using appropriate analytical techniques to generate a comprehensive chemical profile.
This data forms a critical input to toxicological risk assessment and biological evaluation, helping to support clear, scientifically justified conclusions on device safety.

Leachables Simulation and Analysis

We perform leachables studies in accordance with ISO 10993‑18 to assess chemical substances that may be released from a medical device under clinically relevant conditions of use.
Leachables testing is designed to evaluate substances that migrate from the device during normal storage, processing, and clinical use, providing realistic exposure data to support biological safety assessment.
Our leachables studies use simulated‑use or real‑use conditions selected to reflect the device’s intended clinical application, materials, contact duration, and environmental exposure.
Testing may incorporate relevant media, temperatures, and time points to represent patient exposure throughout the device life cycle.
Resulting samples are analysed using appropriate analytical techniques to generate a clinically relevant chemical profile, which is used to support toxicological risk assessment and the overall biological evaluation.

State-of-the-Art Analytical Methods

As part of our ISO 10993‑18 chemical characterisation services, we use a range of advanced analytical techniques to identify and characterise chemical substances associated with medical devices.
These techniques allow us to build a comprehensive understanding of the device’s chemical profile and potential biological relevance.
Methods such as gas chromatography–mass spectrometry (GC‑MS) are used to detect volatile and semi‑volatile organic compounds, while liquid chromatography–mass spectrometry (LC‑MS) is applied to non‑volatile and polar substances.
Inductively coupled plasma–mass spectrometry (ICP‑MS) is used to assess elemental and inorganic components, including metals.
The selection of techniques is tailored to the device materials and extraction or leaching conditions, ensuring appropriate chemical coverage and robust, regulator‑ready data to support biological evaluation and toxicological risk assessment.

Regulatory Alignment

Testing is conducted in accordance with ISO 10993, MDR (EU), and FDA guidance - helping you build a robust chemical characterisation package that holds up to scrutiny.

Frequently Asked Questions

What are extractables and leachables?

Extractables are chemical substances that can be released from a medical device when it is exposed to exaggerated or worst‑case conditions, such as aggressive solvents, elevated temperatures, or extended contact times.
Leachables are substances that migrate from a device under normal or simulated conditions of clinical use, storage, or processing. Together, extractables and leachables testing supports chemical characterisation in accordance with ISO 10993‑18.

Who is chemical characterisation testing for?

Chemical characterisation testing is relevant for any medical device that has patient or user contact, particularly devices with polymeric materials, coatings, inks, adhesives, or complex manufacturing processes. It is commonly required for implantable devices, long‑term contact devices, and products sterilised using methods such as ethylene oxide, where chemical residues may be present.

How are extractables and leachables results used?

Results from extractables and leachables studies are used to support toxicological risk assessment in accordance with ISO 10993‑17. Identified substances are evaluated to determine whether patient or user exposure is within acceptable limits, and the outcomes are documented within the Biological Evaluation Report (BER).

When should chemical characterisation testing be performed during development?

Chemical characterisation testing should be planned early in the development process, once the materials, manufacturing processes, sterilisation method, and intended use are sufficiently defined. Early planning helps identify potential chemical risks, informs the biological evaluation strategy, and reduces the risk of late‑stage testing or regulatory delays. Confirmatory testing is typically performed once the final device configuration is established.

Are ISO 10993‑18 chemical characterisation studies tailored to each device?

Yes, ISO 10993‑18 chemical characterisation studies are tailored to the specific medical device rather than using a one‑size‑fits‑all approach. Study design is based on factors such as the device’s materials, manufacturing processes, sterilisation method, packaging, surface area, contact type, contact duration, and intended clinical use. These factors are used to define appropriate extraction or leaching conditions, analytical techniques, and reporting thresholds, ensuring the study is scientifically justified, clinically relevant, and aligned with regulatory expectations.

No two projects are the same — and that’s exactly how we treat them.

At Test Labs, we’ve been in your shoes.

Before building this laboratory, we spent decades developing products ourselves — designing, iterating, and battling through the pressures of tight timelines, limited resources, and unpredictable testing support. We’ve stood on the other side of the lab wall, waiting for reports that offered little more than a “pass/fail” and no insight. We know that frustration. It’s why we built something different.

Our approach

Early Testing, Real Insights, Better Devices.

Engage us early. That’s when we can make the biggest difference.

Whether you’re testing a first prototype, validating performance claims, or derisking a design decision, we’re here to support you. We’re invested in the same outcome: a better product that performs, protects, and improves lives.

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