Biological Evaluation for Medical Devices Containing Nanomaterials

Currently, ISO 10993 Seires are applicable to nanomaterials in general. However, the test methods, sample preparation, selection of cell lines/animal strains, observation endpoints and interpretation of results for a specific medical device with nanomaterials may be different from those of conventional materials.

We can design and implement specific biological evaluation test methods for different medical devices based on their specific nanoexposure levels.