羟基磷灰石-胶原人工骨材料潜在皮肤致敏性研究
健康九九网 www.health99.org 更新时间:2006-9-20 5:56:02
朱雪涛 黄经春 王 昕 郝树彬 2005-12-13 13:07:03 中华中西医杂志 2003年9月第4卷第17期 关键词 羟基磷灰石-胶原人工骨材料 皮肤致敏 生物学评价 Study on potential sensitiveness of hydroxyapatite-collagen artificial bone materials Zhu Xuetao，Huang Jingchun，Wang Xin，et al. School of Public Health，Shandong University，Jinan250012. 【Abstract】 Objective To study the potential sensitiveness of hydroxyapatite-collagen artificial bone.Methˉods Test extractions was prepared according to Biological evaluation of medical devices-Part12-2000:sample preparation and reference materials are then tested according to Biological evaluation of medical devices-Part10-2000:tests for irritation and sensitization.Results The sensitization potential of the test article in this study was clasˉsified as Grade1（no difference with negative control）.Conclusion No potential sensitiveness was showed. Key words Hydroxyapatite-collagen artificial bone sensitization biological evaluation
【摘要】 目的 研究羟基磷灰石-胶原人工骨材料潜在的皮肤致敏性。方法 按照GB/T16886.12-2000《医疗器械生物学评价第12部分:样品制备与参照样品》的规定制备羟基磷灰石-胶原人工骨材料检验液，然后将检验液按照GB/T16886.10-2000《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，羟基磷灰石-胶原人工骨材料皮肤致敏性为1级（与阴性对照相同）。结论 羟基磷灰石-胶原人工骨材料，无潜在的皮肤致敏性。