现行 YY/T 1843-2022
医用电气设备网络安全基本要求 医用电气设备网络安全基本要求 Basic requirements of cybersecurity for medical electrical equipment
发布日期：2022-05-18
实施日期：2023-06-01
分类信息
发布单位或类别： 中国 行业标准-医药
CCS分类： C30医药、卫生、劳动保护 - 医疗器械 - 医疗器械综合
ICS分类： 11.040.01医疗设备 - 医疗设备综合
研制信息

归口单位： 全国医用电器标准化技术委员会(SAC/TC 10)

起草单位： 上海市医疗器械检测所、 国家药品监督管理局医疗器械技术审评中心、 国家计算机网络应急技术处理协调中心、 中国食品药品检定研究院、 江苏省医疗器械检测所、 苏州UL美华认证有限公司、 深圳迈瑞生物医疗电子股份有限公司、 东软医疗系统股份有限公司、 深圳市理邦精密仪器股份有限公司、 北京怡和嘉业医疗科技股份有限公司、 飞利浦(中国)投资有限公司、 上海西门子医疗器械有限公司、 通用电气医疗系统贸易发展(上海)有限公司、 美敦力(上海)管理有限公司

起草人： 刘重生、 彭亮、 邢潇、 王晨希、 刘茹、 张波、 陶华、 马锐兵、 陈勇强、 陈蓓、 谌达宇、 曹景泰、 秦川、 夏伟杰

标准简介

本文件规定了医用电气设备、医用电气系统及医疗器械软件的网络安全基本要求。本文件适用于有用户访问、电子数据交换或远程控制功能的医用电气设备、医用电气系统及医疗器械软件

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最后更新时间 2025-09-02