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ISO 10993-18: Medical Device Extractables Leachables Testing Using Chemical Characterization
Why Companies Choose NAMSA
118K
Medical Device Tests Run Annually
95%
Test Results Delivered On-Time
2,200
Chemical Characterization Tests Conducted Last Year
3
Major Labs in the US and EU Performing ISO 10993 Testing
World Leader in ISO 10993-18 Lab Testing
Extractables and Leachables (E&L) testing is a crucial process in the evaluation of medical devices NAMSA was the first CRO to start performing chemical characterization on medical device materials and helped develop the standards in use today. NAMSA provides state of the art testing for chemical characterization of medical devices with two Centers of Excellence in the US and Germany. We will work closely with you through the entire journey including study design, testing, and regulatory support.
Numerous Techniques and Lab Equipment for Conducting Chemical Characterization
NAMSA labs in the US and Europe conduct thousands of chemical characterization tests on medical device materials each year. NAMSA test results are widely accepted by regulatory authorities worldwide. Our chemical characterization capabilities include, but are not limited to:
- Differential Scanning Calorimetry (DSC)
- Fourier Transform Infrared Spectroscopy (FTIR)
- Gas Chromatography-Mass Spectrometry (GC-MS) for Semi-Volatiles
- Headspace Gas Chromatography-Mass Spectrometry (HS-GC-MS) for Volatiles
- Inductively Coupled-Plasma Optical Emission Spectroscopy (ICP-OES) for Inorganics/Metals
- Inductively Coupled-Plasma Mass Spectroscopy (ICP-MS) for Inorganics/Metals
- Ion Chromatography (IC) for dissolved ions
- Liquid Chromatography-UV/VIS Spectroscopy for Non-Volatiles
What is the Difference Between Extractables and Leachables?
- Extractables are chemical substances that can be released from a medical device or its materials when exposed to solvents under laboratory conditions. This testing simulates the worst-case scenario to identify potential risks.
- Leachables are substances that may migrate from the device into the patient during normal use. Leachables testing is performed under conditions that mimic the clinical use of the device.
When and Why Chemical Characterization is Conducted
The purpose of chemical characterization is to ensure:
- Biocompatibility
- Patient safety
- Ongoing quality assurance
- Regulatory compliance
- Appropriate long-term material selection
ISO 10993-18 is the primary standard focused on chemical characterization and outlines the methods for identifying and quantifying chemical substances that can be extracted from medical device materials. This standard works in conjunction with other standards such as ISO 10993-17 (allowable limits for leachables) and ISO 10993-1 (biological evaluation). This testing is typically conducted during:
- Product development when materials are being selected
- Preclinical testing, before clinical trials
- Manufacturing validation to ensure no production methods introduce hazardous leachables into final product
- Supplier changes to evaluate new raw materials or finished components
- Post-market monitoring via PMCF studies
These test results are one step in the process of ensuring the ongoing safety of your device and become a vital part of your technical documentation, especially your risk management file.
Meet Our Chemical Characterization Testing Team
Explore the depth of our team’s expertise in E&L testing on medical device materials.
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Alexander Hermann, PhD
Supervisor, Study Director GroupView Bio -
Angela Sanchez
Associate Scientific Director, Analytical ServicesView Bio -
Darin R. Kent, PhD, DABT
Senior Principal ToxicologistView Bio -
Gabriele Bellandi, MSc
Director of German Laboratory OperationsView Bio -
Tim Petermann
Principal ChemistView Bio -
Andy J. Wyen, MS, DABT, LAT
Principal ToxicologistView Bio
Commonly Asked Questions About Our ISO 10993-18 Testing Capabilities
Yes. Instrument redundancy is available at both sites for all key analytical platforms to ensure there is ample capacity to reduce turnaround times. This also allows our clients to conduct their programs seamlessly at either of the two global sites. Expedited testing options are available at both sites to give clients the option to receive their testing results sooner if there is a need.
NAMSA has made significant improvements in reducing the “unknowns” identified during non volatile testing of extracts. Unknowns are less than 1% for all peaks. NAMSA has extensive experience in interpretation and identification of analytes with significant investments made in training and external tools to enhance our interpretation confidence. The lab has established an extensive library covering a wide range of compounds spanning a range of medical devices.
NAMSA has extensive experience working with regulatory bodies have have several team members who previously worked at the US FDA. We will work closely with you after your program is complete to answer questions after submission of data to a regulatory body. This includes joining you in direct discussions with regulatory authorities.
In 2024, the US FDA unveiled a Chemicals List for Analytical Performance (CLAP) dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. The CLAP data set was specific to semi-volatile organic compound (SVOC) extractables data. NAMSA has evaluated FDA CLAP dataset and determined that there is a significant overlap of recommended compounds between CLAP and our internal database. We have been working on building our internal RRF database for all techniques over the past 5 years with chemical compounds covering a variety of chemicals.
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