神经系统接触类器械的生物学评价要点和神经细胞培养技术简介  

The Key Items of Biological Evaluation of Medical Devices Contacted with Nerverous System and Introduction of Nerve Cell Culture Techniques

作　　者：段晓杰[1] 魏利娜[1] 邵安良[1] 陈亮[1] 徐丽明[1] Duan Xiaojie;Wei Lina;Shao Anliang;Chen Liang;Xu Liming(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2018年第9期1251-1256,共6页Chinese Pharmaceutical Affairs

基　　金：科技部重点研发计划"生物源性材料及产品的检测与评价关键技术和标准化研究"(编号2016YFC1103203)

摘　　要：目前,有关与人体神经系统直接或者间接接触的植入类医疗器械越来越多。这些植入类医疗器械可能会引起神经系统结构和/或功能的不利反应,导致广泛的副作用,这些副作用则被称为医疗器械产品的神经毒性。由于神经系统有限的修复能力,因此增加了临床前评价神经毒性的重要性。目前,还没有特定的标准或指南来规范医疗器械产品的神经毒性评价要求。本文结合国内外最新的相关标准和参考文献,给出植入类医疗器械神经毒性评价的要点,为相关产品的临床前安全性评价、质量控制及注册前技术审评提供技术参考。Currently, there are more and more implantable medical devices which directly or indirectly make contact with the human nervous system. These implantable medical devices may cause adverse reactions to the structure and/or function of the nervous system, leading to extensive side effects, which are known as neurotoxicity of medical device products. Due to the limited repair capacity of the nervous system, preclinical evaluation of neurotoxicity becomes important. At present, there are no distinct standards or guidelines to regulate the neurotoxicity evaluation for medical devices. In this paper, based on the latest relevant standards and references at home and abroad, the keypoints of neurotoxicity evaluation for implantable medical devices were introduced, and relevant nervous cells culture techniques were demonstrated in order to provide technical references for preclinical safety assessment, quality control and technical review of related products before registration.

关 键 词：植入类医疗器械 神经系统 神经毒性 神经毒性评价要点 安全性评价 质量控制 

分 类 号：R95[医药卫生—药学]