With regard to the materials used in the manufacture of medical devices, they can generate degradation products when exposed to their biological environment.
In this context, it is important to ensure their level of tolerability for the safety of certain medical devices. To do this, investigations must be carried out to identify and quantify them.
The ISO 10993-15 standard gathers the different general principles for the evaluation and design of degradation studies of materials used in Medical Devices. “Degradation” here means “decomposition of the material”. It deals only with degradation products from metals and alloys.
The method of evaluating degradation varies according to several elements:
the nature of the material studied,
the medical device
its anatomical location