chapter  7
16 Pages

Hemocompatibility (ISO 10993-4)

Hemocompatibility is a lack of signicant adverse interactions of a device with the formed elements of the blood, and it can be one of the most complex of the standard safety concerns in the evaluation of devices. When performed properly for a long-term cardiovascular implant device (such as a stent) as an independent entity, it could also be the most expensive of the standard short-term response endpoints to evaluate. The International Organization for Standardization ISO 10993 Part 4 (Selection of Tests for Interactions with Blood) presents 25 different categories of assays for such evaluations, and U.S. Food and Drug Administration (FDA) expectations have become yet more extensive. While in vitro methods (such as in vitro hemolysis) have historically been used for screening materials (Motlagh et al., 2006), they have severe limitations (as they are only able to evaluate a specic isolated aspect of the hematophoetic system, such as red blood cell membrane fragility).