Why do medical products need to be evaluated for biocompatibility in advance?

Why do medical products need to be evaluated for biocompatibility in advance?

Evaluate whether medical equipment or biomedical materials (indirect or direct contact with the human body) are compatible with the human body and will not release toxic substances during use, causing short-term acute reactions to long-term chronic reactions, such as inducing gene mutations or causing carcinogenesis, etc.

Therefore, it is usually necessary to conduct biological evaluation and biocompatibility testing of medical devices to evaluate the interaction between the device and the patient's tissues, cells or body fluids. The main purpose of biocompatibility assessment is to protect patients from exposure to potential biological risks.