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.  

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. 

FILAB can assist you with the following services: 

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...  

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.

Thank you !

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