The word biocompatibility refers to the interaction between a medical device and the tissues and physiological systems of the patient treated with the device. An evaluation of biocompatibility is one part of the overall safety assessment of a device. Biocompatibility of devices is investigated using analytical chemistry, in vitro tests, and animal models. The biocompatibility of a device depends on several factors, including:
the chemical and physical nature of its component materials
the types of patient tissue that will be exposed to the device
the duration of that exposure
Of course, the primary purpose of a device biocompatibility assessment is to protect patient safety. Manufacturers will also want to consider corporate regulatory goals and compliance risks in planning a biocompatibility testing program. Inevitably, evaluating the biocompatibility of a device is a risk assessment exercise. There is no risk-free device or device material. The goal of device designers is to minimize risk while maximizing benefit to patients.