[Current status of the study on complement activation by solid biomaterial].
OBJECTIVE
To 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.


METHODS
Analyzed 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.


CONCLUSIONS
The 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.
Chenghu
Liu
L
Shandong Quality Inspection Center for Medical Devices, Jinan, 250101. liuchenghu510@163.com
Ping
Wu
W
Yanping
Shi
S
D001672:Biocompatible Materials / Q000494:pharmacology*; D003167:Complement Activation / Q000187:drug effects*
D001672:Biocompatible Materials