Blood-contacting medical devices and the materials from which they are constructed must meet stringent safety criteria prior to regulatory approval for sale and distribution. Key among these requirements is the need for hemocompatibility testing, governed by the international standard ISO-10993-4 – recently updated to reflect some of the most recent advances in the science of blood compatibility.
One of the primary requirements for blood-contacting medical devices such as catheters, sheaths, introducers, wires and the whole family of implantables such as stents and valves is the ability of the intact device or the material from which it is constructed to offer resistance to platelet adhesion, activation and eventual blood clot formation. In other words, blood-contacting devices need to demonstrate materials-mediated thromboresistance.
