4.2 Biocompatibility and the Relationship to Standards: Meaning and Scope of Biomaterials Testing

Abstract

This chapter presents biocompatibility (safety) evaluation of biomaterials, medical devices, and prostheses in the context of current standards and guidelines. The goal of this chapter is to provide an overview for the biological response evaluation, that is, biocompatibility evaluation, of end-stage ‘as-used’ medical devices, prostheses, and biomaterials. The chapter contains eight sections: biocompatibility; materials for medical devices; in vitro tests for biocompatibility; in vivo tests for biocompatibility; inflammation, wound healing, and the foreign body reaction; hemocompatibility; immune responses; and summary. It must be emphasized that standards, tests, and guidelines are constantly evolving and changing, and it can be anticipated that new information will provide new perspectives on immune response evaluation in the areas of tissue engineering and regenerative medicine.