OBJECTIVETo improve our comprehensions to complement activation by biomaterial and lay the foundation for biosafety evaluation of solid biomaterials together with the corresponding blood contacting medical devices.

METHODSAnalyzed new requirements of current standards on complement activation by solid biomaterial as well as the mechanism of complement activation by solid biomaterial and how to select the related standards for inspection.

RESULTS AND CONCLUSIONThe new edition of international standards has enhanced types of blood contacting medical devices which are appropriate to complement activation test. It is badly in need of establishing the corresponding industry standards to regulate these requirements, since there have no uniform and admissive methods for inspection of complement activation by solid biomaterial.