中国药物评价2024，Vol.41Issue(3)：177-179,3.
GB 9706.1-2020标准实施技术审评关注点
Technical Review Focus on GB 9706.1-2020
郑晨 1赵扬 2杨鹏飞1
作者信息
- 1. 国家药品监督管理局医疗器械技术审评中心,北京 100081
- 2. 上海市医疗器械检验研究院,上海 200120
- 折叠
摘要
Abstract
New edition of GB 9706.1-2020 Medical electrical equipment-Part 1:General requirements for basic safety and essential performance implemented on May 1,2023.Comparing with GB 9706.1-2007,GB 9706.1-2020 adds requirements for risk management,basic performance,lifetime,and availability,integrates safety requirements for medical electrical systems and requirements for program-mable medical electrical systems,and adds content to distinguish between operator protection and patient protection.This article analyzes the technical evaluation focus based on the main changes in GB 9706.1-2020,in order to help technical reviewer of regulatory authorities and applicant of enterprise in preparing application materials during registration process.关键词
医用电气设备/GB9706.1-2020/技术审评/风险管理/注册申报Key words
Medical electrical equipment/GB9706.1-2020/Technical evaluation/Risk management/Medical-Device-Registration分类
医药卫生引用本文复制引用
郑晨,赵扬,杨鹏飞..GB 9706.1-2020标准实施技术审评关注点[J].中国药物评价,2024,41(3):177-179,3.
