Biological safety evaluation of medical devices

There are many instruments or components in medical device products that come into direct or indirect contact with the human body, and during the process of contact with organisms, there may be a series of biological reactions and device (or material) reactions that do not correspond to the purpose of application, and the results of these reactions may jeopardize the health of users and may also affect the normal function of medical devices, so medical devices, before clinical application, need to carry out systematic biological evaluation.