Medical devices - assessment of implanted materials

For the assessment of the safety of medical devices according to ISO 10993, the materials of which they are made need to be toxicologically assessed.

If some of the materials are embedded under a coating of other materials the exposure will not be directly evident. Yet in case of leakage the assessor should assure that even those materials are having as low a toxicity as possible from a safe-by-design perspective.

When assessing the toxicity of the materials the assessor can choose to look at the whole literature regardless of exposure pathway. However, sometimes sufficient studies on the correct exposure pathways may be available.

Relevant pathways of exposure are often dermal exposure, mucosal surface exposure or implantation - even the oral pathway is likely not the correct one to consider for devices that are swallowed - here mucosal surface exposure seems most relevant.

We have collected the literature on silver regarding all three pathways.

Implanted silver

Dermal and mucosal surface silver