摘要
对于直接或间接接触人体的医疗器械来说,生物相容性评价是风险管理过程中非常重要的方面,贯穿于产品全生命周期。该文介绍了医疗器械生物相容性评价的开展路径和方式,以及对评价结果的接受准则;分析了国内外医疗器械生物相容性评价发展历史和趋势。结果表明,综合利用各种已有信息与选择补充试验相结合的方式来提供医疗器械生物学风险可接受的科学证据,已成为各监管机构的共识。面对新材料、新技术的不断涌现,世界各国都在不断更新生物相容性评价理念和工具。我国也需要通过深入的医疗器械监管科学研究,进一步建立和完善医疗器械生物相容性评价体系。
Biocompatibility evaluation is a very important aspect in the process of risk management for medical devices that directly or indirectly contact with human body,which runs through the whole life cycle of products.This paper introduces the path and method of biocompatibility evaluation of medical devices,as well as the acceptance criteria of evaluation results;The development history and trend of biocompatibility evaluation of medical devices at home and abroad were analyzed.The results show that it has become the consensus of regulatory agencies to provide scientific evidence of biological risk acceptability of medical devices by combining various existing information and selecting supplementary tests.With the emergence of new materials and new technologies,the concept and tools of biocompatibility evaluation are constantly updated all over the world.China also needs to further establish and improve the biocompatibility evaluation system of medical devices through in-depth regulatory science research on medical devices.
作者
赵鹏
邢丽娜
刘文博
叶成红
ZHAO Peng;XING Li-na;LIU Wen-bo;YE Cheng-hong(Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081)
出处
《中国医疗器械信息》
2021年第11期1-4,共4页
China Medical Device Information
关键词
医疗器械
生物相容性
生物学评价
监管科学
medical device
biocompatibility
biological evaluation
regulatory science
