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Toxicological evaluation of leachable substances according to ISO 10993-17
You wish to perform a toxicological evaluation of the releasable substances of your medical devices according to ISO 10993-17
The ISO 10993-17 standard applies only to medical devices with which patients come into contact. This standard enables hazardous toxic substances to be identified and quantified by determining a systematic procedure. Â
With the support of a partner laboratory, FILAB assists you in carrying out the toxicological evaluation of substances that can be released from your medical devices in accordance with the ISO 10993-17 standard in addition to chemical characterization tests (ISO 10993-18).
In France, FILAB is one of the few laboratories in the medical device sector to offer you a complete analytical facility of 2100 m² for physicochemical analyses as part of the biological evaluation of your medical devices.Â
FILAB can assist you with the following services:Â
Our services
Chemical characterization according to ISO 10993-18
Cytotoxicity test according to ISO 10993-5
Degradation study according to ISO 10993-13 / -14 / -15
We can also offer, with the support of a partner laboratory, the following services
- Cytotoxicity test according to ISO 10993-5
- Toxicological evaluation of leachable substances according to ISO 10993-17
- Skin irritation and sensitization test according to ISO 10993-10
But also for...
R&D support: custom chemical analysis, material and surface characterization, analytical development
Process validation: Cleaning (ISO 19227), surface treatment
Problem solving: non-conformity, breakage, adhesion, corrosion... Â
Our human size, our permanent investments and our knowledge of the medical devices sector guarantee to our customers a reliability of the results, a fast treatment of the requests and a tailor-made support of their needs.
How to contact us ?
For more information, contact us at contact@filab.fr or 03 80 52 32 05.
Caroline KURZAWA
R&D Project Engineer
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