Biological safety evaluation of polymers

Abstract

During the last several years, a variety of degradable polymeric materials and medical devices have been developed, and their biological safety evaluation has evolved from screening assays. However, the clinical application of these materials and medical devices is still a critical issue due to the host responses resulting from inflammatory reactions and foreign-body response in their presence or their degraded toxic components in the body. Therefore, every degradable polymeric material and medical device used in biomedical applications needs to be screened for its biological safety. This chapter focuses on the biological response following implantation of degradable biomaterials and some methods for biological safety evaluation of degradable biomaterials recommended by the International Organization for Standardization (ISO) 10993 standard and US Food and Drug Administration (FDA) agency.