The term Biocompatibility is described for the specific property of a material being compatible with living tissue. Biocompatible materials do not produce a toxic or immunological response when exposed to the body or bodily fluids.
|The ISO 10993-1:2018 standard defines Biocompatibility as the ability of a medical device or material to perform with an appropriate host response in a specific application.
Which means the compatibility of a device to a biological system. That is in simple words a state in which Biological system (living thing) and a medical device or material are able to exist or occur together without any toxicological or undesirable problems or conflict.
ISO 10993-1:2020. Is it Harmonized?
A harmonized standard is a European standard developed by a recognized European Standards Organization such as CEN, CENELEC, or ETSI.
EN ISO 10993-1:2020 is know as Biological evaluation of medical devices. Evaluation and testing within a risk management process