Extractables and Leachables
The physical and chemical characterization of materials has become the first stage of biocompatibility testing as per ISO 10993. These studies, also known as extractables and leachables studies, are important for patient safety and intended to identify and quantify harmful leachable impurities which could leach from Medical Devices and poses a health risk.
Eurofins Medical Device Testing has been assisting Medical Device customers with chemical characterization for over 30 years. Our analytical chemistry laboratories are equipped with more than 500 chromatography systems and our highly trained chemists performed over four hundred extractable studies in 2016 alone.
Eurofins will support your needs during the entire E&L flow:
- Setting up an extractable approach for your product and write your protocol
- Perform an extractable study
- Evaluate data through an toxicological assessment
- Implement a suitable Leachable strategy
Extractable studies are performed through semi-quantitative methods. We set-up proposals based on the client’s needs and the specific scenario (extraction conditions, solvents, time, and temperature).
The extraction solutions will be analyzed by different analytical techniques through quality-quantitative screening methods wherever applicable:
- HPLC-UV-MS for non-volatile organic compounds
- GC/MS for Organic Semi-volatile Compounds
- Headspace GC/MS for Volatile Organic Compounds
- ICP/OES for specific target metals
If you want to discuss your project or request a quotation, feel free to contact us.
If you would like more information about our Medical Device testing capabilities, please also visit our global Medical Device website using the following link: https://www.eurofins.com/medical-device/