Evaluation of Biomaterials: Histopathology Techniques Used in the Screening of Biomaterials to Ensure Biocompatibility

Biocompatibility testing is a major pre-clinical safety screening process used to examine or anticipate the nature of any biomaterial intended for medical use. The chemical nature and physical qualities of the substance, the contact tissue, the duration of contact, and the site/tissue of implantation all influence biocompatibility. The International Organization for Standardization provides global regulatory venues for evaluating biocompatibility. The gold standard for determining tissue biocompatibility is the micromorphological examination of tissue response following implantation in an animal model at an acceptable site. Along with the ongoing development of the concept of biomaterials, biocompatibility assessment standards and regulations are also evolving, albeit at a considerably slower rate. Even if new standards for each type of biomedical device are published over time, many of the standard documents require revolutionary changes. This chapter provides a brief overview of the biocompatibility evaluation concept as well as the techniques/procedures used to screen biomaterials for tissue compatibility.