关于医疗设备安全设计思维的探讨  

Discussion on Safe Design Thinking of Medical Devices

作　　者：黄煜 乔峰 官辉 兰婉玲 李云鹤 石盛东 HUANG Yu;QIAO Feng;GUAN Hui;LAN Wan-ling;LI Yun-he;SHI Sheng-dong(Sichuan Provincial Institute of Drug Control(Sichuan Provincial Medical Device Testing Center),Sichuan Chengdu 610045)

机构地区：[1]四川省药品检验研究院(四川省医疗器械检测中心),四川成都610045

出　　处：《中国医疗器械信息》2024年第1期1-4,共4页China Medical Device Information

基　　金：四川省科技计划项目(重点研发项目)(项目编号:2023YFS0017)。

摘　　要：随着我国人民生活水平的提高和医疗保健意识的增强,医疗设备产业也随之蓬勃发展,医疗设备日新月异,加之新技术在医疗设备上的应用,安全性一直都是医疗设备设计、生产和使用的核心与重点。结合GB9706.1-2020标准的具体内容,从风险控制的角度分析医疗设备的安全设计思维,并阐述安全设计中需要考虑的因素与方法。With the improvement of people’s living and the enhancement of medical care awareness,the development of medical equipment industry is also booming,a wide variety of medical equipment is changing with each passing day,coupled with the application of new technologies in medical equipment,safety has always been a core and focus in the design,production and use of medical devices.This paper analyzes the thinking of medical device safe design from the risk control combines the specific content of standard GB9706.1-2020,and expounds the methods and factors that need to be considered in the safety design of medical equipment.

关 键 词：医疗设备 安全设计等级 风险控制 安全设计思维 

分 类 号：R197.39[医药卫生—卫生事业管理]