【摘要】 目的 研究甲壳胺-生物止血愈合海绵潜在的皮肤致敏性。方法 按照GB/T16886.12-2005《医疗器械生物学评价第12部分：样品制备与参照样品》的规定制备甲壳胺-生物止血愈合海绵检验液，将检验液按照GB/T16886.10-2005《医疗器械生物学评价 第10部分：刺激与致敏试验》中的规定进行皮肤致敏试验。结果 本项试验中，甲壳胺-生物止血愈合海绵皮肤致敏性为1级(与阴性对照相同)。结论 本产品无潜在的皮肤致敏性。

    【关键词】 甲壳胺-生物止血愈合海绵；皮肤致敏；生物学评价

    Study on potential sensitiveness of chitosan bio-sponge for healing of skin

    HAO Shu-bin，ZHU Xue-tao，HUANG Jing-chun，et al.School of Public Health，Shandong University，Jinan 250012，China

    【Abstract】 Objective To study the potential sensitiveness of chitosan bio-sponge for healing. Methods Testing extractions was prepared according to biological evaluation of medical devices-Part 12-2005: sample preparation and reference materials and then tested according to biological evaluation of medical devices-Part 10-2005: tests for irritation and sensitization.Results The sensitization potential of the test article in this study was classified as grade 1(no difference with negative control). Conclusion No potential sensitiveness on skin was showed. ......