What is Biocompatibility?
What is Biocompatibility? – “Medical devices that come into direct or indirect contact with the body” are assessed “for the possibility for an unacceptable adverse biological reaction caused by contact of the device’s component materials with the body.”
The term Biocompatibility is described for the specific property of 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 preceding discussion is about individual (bio)materials. It is reasonable to extend the biocompatibility idea to encompass devices that are made up of many materials, including implants, pacemakers, and drug delivery systems, and to discuss their biocompatibility. In a device made up of two materials, for example, both materials must be biocompatible in the tissue(s) where they are used. Furthermore, there must be no negative crosstalk between the materials or the tissue reactions they elicit. Then we may discuss a biocompatible gadget.
|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 a 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 known as the Biological evaluation of medical devices. Evaluation and testing within a risk management process.