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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 :
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 :
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.