Medical Device characterization in accordance with the ISO 10993-19 standard

FILAB laboratory is able to assist you in characterizing your medical devices in accordance with the ISO 10993-19 standard

The ISO 10993-19 standard provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, physicochemical, morphological and topographical (PMT) properties of materials in finished medical devices. PMT parameters play an important role in evaluating the biocompatibility and the clinical efficiency of medical devices.

The ISO 10993-19 standard therefore states which properties are to be taken into consideration when characterizing the PMT parameters of materials containing polymers, metals, alloys, ceramics, and natural macromolecules.

With support from a partner laboratory, FILAB is able to assist you in evaluating the biocompatibility of your Medical Devices by conducting the following tests :

Our tests

  • Chemical characterization in accordance with the ISO 10993-19 standard

  • Degradation testing in accordance with the ISO 10993-13, ISO 10993-14 and ISO 10993-15 standards

  • Chemical characterization in accordance with the ISO 10993-18 standard

  • Nanomaterial characterization in accordance with the ISO 10993-22 standard 

We are also able to provide the following services :

Our services

  • Cytotoxicity testing in accordance with the ISO 10993-5 standard

  • Skin irritation testing in accordance with the ISO 10993-10 standard  

  • Toxicological evaluations of leachable substances in accordance with the ISO 10993-17 standard

The fact that we work on a human scale, our continuous investments and our extensive knowledge of the field of Medical Devices all ensure the reliability of our results, a quick turnaround for requests and tailored support suited to your needs.

How to contact us

For more information, feel free to contact us via email at contact@filab.fr or over the phone by calling +33 (0)3 80 52 32 05.

Thank you !

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