Biocompatibility and Norms

Biomaterials lead to various and numerous biological reactions and interactions that have to be controlled to be qualified as biocompatible. “Biocompatibility” groups a set of performances that a biomaterial has to assure to be used in therapeutic purposes and to improve the quality and duration of the life of a patient. In research laboratories, “biocompatibility” is evaluated through “specific” in vitro and in vivo tests to conclude on a mechanism of the observed biocompatibility. The initial product is a laboratory “product”, the biological properties of which are to be evaluated. When the biomaterials are intended to be implanted in a patient, the biocompatibility has to be validated and this is done by the series of tests imposed by Norms–ISO EN NORMS 10993 in Europe. Some biomaterials were successfully used for one or several applications such as poly(methyl methacrylate) used in 1937 in dentistry then in ophthalmology.