生物医用材料的生物相容性评价

Studies on Biocompatibility of Biomedical Materials

目的评价四大类生物医用材料的生物相容性。方法依据ISO 10993系列标准,采用细胞毒性试验、致敏试验、皮内刺激试验、急性毒性试验、溶血试验、植入试验、染色体畸变试验、微核试验、Ames试验、热原试验对生物医用材料的生物相容性进行评估。结果生物医用金属材料、生物医用高分子材料、医用敷料类和其他类的合格率分别为98.63%、89.40%、99.91%和99.63%。结论四大类生物医用材料均有良好的生物相容性。

Objective To evaluate the biocompatibilities of four species of biomedical materials.Methods According to the standard of the ISO 10993,the biocompatibilities of the biomedical materials were evaluated by using the cell cytotoxic test,sensitization test,intracutaneous stimulation tests,acute toxicity test,hemolysis test,implantation test,chromosomal aberration tests,micronucleus tests,Ames tests and pyrogen tests.Results The qualification rate of the biomedical metals,biomedical polymers,medical dressings and other materials was 98.63%,89.40%,99.91% and 99.63% respectively.Conclusion Four species of biomedical materials all have good biocompatibility.