植入性医疗器械的临床前免疫毒性评价

Preclinical immunotoxicity evaluation of implantable medical devices

阐述了植入性医疗器械的临床前免疫毒性评价工作。介绍了医疗器械免疫毒性评价的发展历程,概述了相关法律法规及其对相关评价做出的指导。讨论了植入性医疗器械免疫毒性评价的具体实施,包括降解产物潜在危害、医疗器械风险评估、与血液相互作用试验、体外细胞毒性试验、植入后局部反应试验、刺激与迟发型过敏反应试验以及全身毒性试验等。分析了植入性医疗器械免疫毒性评价的主要免疫毒性反应及其检测,提出了在研究实验时存在的不足,对植入性医疗器械的下一步研究及未来发展进行了展望。

The preclinical immunotoxicity evaluation of implantable medical devices was described. Firstly, the guidelines and regulations about the immunotoxicity evaluation of medical devices were summarized. These documents directed the immunotoxicity evaluation of implantable medical devices. Secondly, various aspects concerning the design of the immunotoxicity evaluation experiments were discussed here, including the hazardous effect of potential degradation products,the risk management of medical devices, the tests for interactions, the tests for in vitro cytotoxicity, the tests for local effects after implantation, the tests for irritation and delayed-type hypersensitivity, the tests for systemic toxicity. Thirdly, different types of immune responses with regard to immunotoxicity evaluation were listed and introduced here. In the end, the evaluation of implantable medical devices was expected to be more rigorous in the future.