Testing the in vivo biocompatibility of biocomposites

The evaluation of the biocompatibility of a material before clinical use is a long trial that requires a well planned sequence of steps. These procedures are now standardized at an international level. In particular, in the European Community, the rules of EN ISO 10993 are the guideline for each investigation in this field. The in vivo tests of biocompatibility are complementary to those performed in vitro and require compliance to the ethical and legal rules on animal experimentation. Biocompatibility tests must be performed on the final product or material, taking into account the nature, duration and conditions of the exposure in the human body, the physical and chemical features of the product, the toxicological activity of the chemical elements or compounds, and the presence of leachable materials. The tests should be applied with interpretation and judgement by the appropriate professionals qualified by training and experience taking into consideration factors relevant to the device/material, its intended use, and the current knowledge of the device/material provided by scientific reports and previous clinical experience.