YY/T 9706.106-2021《医用电气设备第1-6部分:基本安全和基本性能的通用要求并列标准:可用性》标准要求分析与探讨  

Analysis and Discussion on Standard Requirements of YY/T 9706.106-2021 Medical Electrical Equipment-Part 1-6:General Requirements for Basic Safety and Essential Performance-Collateral Standard:Usability

作　　者：樊琳 FAN Lin(Shanghai Institute of Medical Device Testing,Shanghai 201318;NMPA Key Laboratory for Medical Electrical Equipment,Shanghai 201318)

机构地区：[1]上海市医疗器械检验研究院,上海201318 [2]国家药品监督管理局医用电气设备重点实验室,上海201318

出　　处：《中国医疗器械信息》2024年第21期35-37,47,共4页China Medical Device Information

摘　　要：YY/T 9706.106-2021对制造商实施医用电气设备的可用性过程进行了规定。文章深入分析检测中常见的可用性资料问题及其原因,介绍标准的要求和内容,旨在帮助制造商更好地理解和应用标准,为制造商提供正确、完整的可用性工程资料文档提供指导,希望促进医疗器械可用性的高质量发展。YY/T 9706.106-2021 sets requirements for manufacturers to analyse,specify,design,verify and validate usability related to basic safety and basic performance of medical electrical equipment.This paper deeply analyzes the common problems found in usability engineering documents during testing and their causes,and introduces the requirements and contents of standards.The purpose of this paper is to help manufacturers better understand and apply the standards,and to provide guidance for manufacturers to provide correct and complete usability engineering documentation,hoping to promote the high-quality development of medical device usability.

关 键 词：医疗器械 医用电气设备 可用性工程资料 人因工程 标准 

分 类 号：TH772[机械工程—仪器科学与技术]