Standard No.:	DB32/T 5123-2025
English Name:	General technical specification for usability test of medical device
Chinese Name:	医疗器械可用性测试通用技术规范
Chinese Classification:	C37    General requirements on medical devices
Professional Classification:	DB    Provincial Standard
ICS Classification:	11.040.60 11.040.60    Therapy equipment 11.040.60
Source Content Issued by:	Jiangsu Adminstration of Market Regulation
Issued on:	2025-04-16
Implemented on:	2025-5-16
Status:	valid
Target Language:	English
File Format:	PDF

本文件规定了医疗器械可用性测试的基本要求,分别描述了形成性测试和总结性测试。
本文件适用于以医疗器械人因工程设计验证与确认为目的、以用户测试为主要手段的可用性测试。
注:人因工程设计是指对人类行为、能力、局限性和其他特性知识的应用来设计医疗器械(包括软件)、系统、任务,以获得足够的可用性。