医疗器械的免疫毒性评价

Evaluation of Immunological Toxicity of Medical Devices

随着对生物材料生物相容性研究工作的不断深入,以及医疗器械在临床使用过程中所出现的一些问题,人们开始认识到医疗器械与人体免疫系统之间相互作用的重要性。单独致敏试验不能全面地评价生物材料类医疗器械免疫学的各个方面,不能为生物材料的临床使用提供安全有效的试验资料,不能为管理机构的决策提供可靠的技术数据。本文着重介绍了医疗器械免疫毒性试验原理和方法。

There has been increasing attention over the past few years on the potential for the medical devices to cause changes in the immune systems, and it was necessary to provide guidance on how to address the adverse effects of medical devices on the immune system. Here we introduce the principles and methods for immunotoxicology testing of medical devices.