Bio-compatibility Matrix

What is bio-compatibility?

Bio-compatibility refers to the behaviour of the materials that are used in developing the device under various circumstances. It tells us about how a material behaves and responds in front of a host substance. The IUPAC defines it as "the ability of a material to perform with an appropriate host response in a specific application¹. General definition would be “the ability to be in contact with a living system without producing an adverse effect².” Biocompatibility is the ability of a material or device to remain biologically inactive during the implantation period⁴.

Hence all products that are used for human use need to have biocompatibility. This is specially required for all medical devices that enter into the human system in any part from any portion.

ISO 10993-1 provides details of the criteria that the medical devices should meet based upon their contact with the body and extent or duration of contact.

* P indicate data end points that can be necessary for a biological safety evaluation, based on a risk analysis. Where existing data is adequate, additional testing is not required.

For further information on biocompatibility requirements of medical devices please refer ISO 10993 set of standards.

References:

1.     Wikipedia

2.     Pure Appl. Chem., Vol. 84, No. 2, pp. 377–410, 2012.

3.     ISO 10993-1:2009; © ISO 2009
4.   Encyclopedia of Medical Devices and Instrumentation, 2nd Edition, Jon G Webster, Vol.1, page 8.