Study Design and Methodologies for Study of Ocular Medical Devices

This chapter focuses on the test methods necessary to demonstrate the safety and “biocompatibility” of ocular medical devices. Biocompatibility has a variety of definitions, but in general it is the quality of the medical device or biomaterial to not have toxic, adverse, or injurious effects on biological systems. The test methods described in this chapter are the commonly used routine test methods for establishing biocompatibility.