摘要
柔性电子是将有机或无机材料电子器件制作在柔性或可延性基底上的新兴电子技术,该技术的兴起使研制新一代可穿戴和植入式有源医疗器械成为可能。柔性电子技术应用于医疗器械前应验证其在预期用途中的安全性和有效性。通过阐述柔性电子技术在医疗健康领域的最新研究进展,从监管科学角度探索柔性电子技术在医疗器械中应用所需的安全性和有效性,初步建立适合柔性电子技术特点的评价体系,探讨使用柔性电子技术的可穿戴和植入式医疗器械机械性能、电子性能与其生物相容性间的关系,促进我国新一代可穿戴和植入式医疗器械的研发及上市,使患者从先进医疗技术的发展中获益。
Flexible electronic technology is a newly-developing electronic technique which made the electron device of organic or inorganic material in flexible or stretchable materials.With the emergence of this technology,it is possible to develop a new generation of wearable and implantable active medical devices.The safety and effectiveness of flexible electronic technique in anticipated use should be verified before it is applied in medical device.This research explored the necessary safety and effectiveness of flexible electronic technique that were applied in medical device from the science point of supervision,and primarily established an evaluation system that suited to the characteristics of flexible electronic technique through elaborated the latest research progress of flexible electronic technique in the field of medical health.This paper also discussed the relations between the mechanical property and electric property of wearable and implantable medical device that adopted flexible electronic technique,and its biocompatibility.This research would promote the research&development and marketing of new generation of wearable and implantable medical devices in China,and the patients would benefit from the development of advanced medical technology timely.
作者
陈宽
许伟
张嵩
CHEN Kuan;XU Wei;ZHANG Song(Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081,China)
出处
《中国医学装备》
2020年第12期191-196,共6页
China Medical Equipment
基金
科技部国家重点研发计划(2018YFC2000801)“主动健康数据采集产品的安全性和有效性评价规范研究”。
关键词
柔性电子技术
穿戴式
植入
安全性
有效性
Flexible electronics technique
Wearable type
Implantation
Safety
Effectiveness
