Biological evaluation of scaffold materials for external skeletal fixation / 医疗卫生装备

ABSTRACT

Objective To provide integral biological assessment on carbon fiber,aluminum alloy (6061)and stainless steel (05Cr17Ni4Cu4Nb)for external skeletal fixation.Methods According to biological evaluation criterion of medical devices, four tests in vitro and vivo were selected on the basis of the GB/T 14233.2—2005 and GB/T 16886 serial standards. The cytotoxicity test determined with MTT method. Acute general toxicity test, tests for irritation and delayed -type hypersensitivity were to evaluate biological safety by two leaching media of polar solvent (sodium chloride) and nonpolar solvent (cottonseed oil).Results The scaffold materials of external skeletal fixation had no cell toxicity in vitro.The three materials had none of acute general toxicity, skin irritation and sensitization in sodium chloride and cottonseed oil. Conclusion Carbon fiber,aluminum alloy (6061)and stainless steel (05Cr17Ni4Cu4Nb)are kinds of bone external scaffold materials with high biocompatibility and can be safely applied for clinical use.