For medical devices, toxicology relates to the abilities of the materials to exert unwanted effects on the human body.
This can be due to the material itself, its leachables , degradation products or processing agents used in manufacturing.
Numerous toxicological endpoints are of high importance in the development of medical devices. For skin contacting devices skin irritation and skin sensitisation are e.g. of high importance. For medical devices being in contact with the interior of the body or even implanted such endpoints as compatibility with the blood need to be investigated.
The toxicity of medical devices is mainly regulated through the ISO 10993 guideline. SAXOCON has employees that are specialists in this guideline.