ABSTRACT
Perfluorocarbon-based ‘‘blood substitutes’’ are more closely related to devices than to pharmaceuticals in the sense that they perform a function that is primarily physical. These blood substitutes are intended to promote a rapid and reversible exchange of blood gases without impairing the functions of
blood elements, the flow of fluids, or the performance of organs. To be acceptable for injection, a perfluorocarbon emulsion must meet specific requirements of hemocompatibility and biocompatibility (1). These requirements include the following:
Be miscible with blood in all proportions without undergoing phase changes, precipitation, flocculation, or coalescence.
