15 – Testing the in vivo biocompatibility of biocomposites

The evaluation of the biocompatibility of a material prior to its clinical use is a long trial that requires a well-planned sequence of steps. These procedures are now standardised 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. First of all, they are required to comply with the ethical and international legal rules on animal experimentation. The biocompatibility tests must be performed on the final product or the material, taking into account the nature, duration, and human exposure conditions; the physical and chemical features of the product; the toxicological activity of the chemical elements or compounds; and the presence of degradable materials. The tests should be applied with interpretation and judgement by professionals qualified by training and experience taking into consideration the factor relevant to the device/material, its intended use, and the current knowledge of the device/material provided by scientific literature and previous clinical experience. In the last years, researchers are prompted to find effective alternative methods or longitudinal techniques to reduce the number of animals applying the principles of reduction, refinement, and replacement.