As part of the biological assessment of medical devices, we offer standardized analytical methods and customized studies for chemical characterization of medical devices according to ISO 10993-18.
Our services
- Chemical characterization of materials (ISO 10993-18)
- Physical/chemical, mechanical and morphological characterization (ISO 10993-19)
- Qualitative and quantitative detection of degradation products in medical devices made of polymers (ISO 10993-13)
- Qualitative and quantitative detection of ceramic degradation products (ISO 10993-14)
- Qualitative and quantitative detection of degradation products from metals and alloys (ISO 10993-15)
- Detection of permissible limits for leachable components (ISO 10993-17)
Eurofins will support your needs during the entire E&L flow
Analytical methods and concepts are in line with Extractables and Leachables studies for packaging materials and end products. In addition, rapid and cost-effective solutions are needed to compare medical devices after design and material changes, as well as after changes in starting materials, production batch or aging.
To achieve this, we use GC / HPLC / ICP fingerprinting, standardized analytical procedures taking into account existing material and manufacturing data, which leads to a complete chemical characterization of medical devices.
In certain cases, a tailored study is recommended for a complete characterization and safety assessment. Thanks to our expertise in both medical devices and pharmaceutical packaging, we are able to assist you in designing such a tailored study protocol (extraction temperature and duration, simulants used, etc.), which is required for the analytical evaluation of the extractables and their toxicological assessment.
We can support you with:
- 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
Risk assessment and Toxicological evaluation
To better understand the safety profile of your medical devices, Eurofins Medical Device Testing network performs risk assessments and toxicological evaluations for you.
With the help of such a safety profile, additional analytical testing and biocompatibility testing can be scheduled. Furthermore, the safety profiles can be used in conjunction with the preclinical data for a comprehensive risk assessment.
These assessments are based on ISO 10993-17 and are used to identify and critically evaluate potential toxicities and exposures to humans. Both the final medical product and individual chemical compounds, additives, colorants, processing aids and potential extracts are considered.
If you want to discuss your project with our Business Development Manager Anja Kroon 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/
