Medical Device characterization 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 :