GB 9706.1-2020及系列标准的实施对家庭护理环境中使用的特定电磁波治疗器的设计要求  

The Design Requirements of Enforcement of GB 9706.1-2020 and Its Series Standards to Specific Electromagnetic Wave Therapy Devices Used in the Home Care Environment

作　　者：陈卫 周平[1] CHEN Wei;ZHOU Ping(Chongqing Centre for Medical Device Control,Chongqing 400799)

机构地区：[1]重庆医疗器械质量检验中心,重庆400799

出　　处：《中国医疗器械信息》2023年第11期11-14,176,共5页China Medical Device Information

摘　　要：根据将于2023年5月1日强制实施的GB 9706.1-2020及其配套系列标准,家庭护理环境中使用的特定电磁波治疗器(别称TDP特定电磁波治疗仪,简称TDP)产品适用的医疗器械标准及其要求将会出现较大变化,导致绝大部分已上市的此类产品需要进行较大结构性的变化。文章主要以强制标准要求为原则,从性能指标、通用安全和专用安全要求三个方面,结合TDP的使用环境及其预期用途,对产品的设计变更要点进行分析,梳理总结出关键的设计要点,以供TDP产品设计变更和质量控制参考使用。According to GB 9706.1-2020 and its supporting series of standards,which will be enforced on May 1,2023,the applicable medical device standards and their requirements for specific electromagnetic wave therapy devices(TDP)used in home care environments will be significantly changed,resulting in most of such products already on the market have to change dramatically in their structures.Based on the principle of the requirements of mandatory standards and combined with the use environment of TDP and its intended use,this paper analyzes the key points for the modify of design from performance parameters,general safety and special safety requirements,and summarizes the key design points for reference of TDP product design changes and quality control.

关 键 词：特定电磁波治疗器 家庭护理环境 GB 9706.1-2020系列标准 设计要求 

分 类 号：TH772[机械工程—仪器科学与技术]