An animal study is one of the most important steps in the process of translating biomaterials to clinical applications. But before going further to clinical trials, ISO 10993 standard will be ran to find out the initial biocompatibility of the material. Biocompatibility of the device depends on some of these factors: the chemical and physical nature of its component material, patient tissue types that it will be exposed to the biomaterial and the life-time exposure of the biomaterial.
ISO 10993 includes the following tests Cytotoxicity, Genotoxicity, Irritation, Systemic Tox, Hemocompatibility, Implantation, Toxikokinetics Chronic toxicity and carcinogenicity that helps evaluate the biocompatibility of a material. For example, a skin surface device will require Cytotoxicity, Sensitization and Irritation evaluation testing, compare to a bone/tissue implant device that would require more testing evaluation as follow; Cytotoxicity, Sensitization, Irritation, Implantation, Chronic toxicity and carcinogenicity.