When extracts of a medical device are required for a biocompatibility test protocol, a current practice is to follow the guidance in ISO 10993 Biological evaluation of medical devices–Part 12: Sample ...

Intramuscular implantation assesses local tissue response to an implanted material for the ISO 10996-6 implantation test. However, manufacturers are on their own when it comes to how best to fulfill ...

The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that may not be biocompatible for use in ...