家用射频美容设备可用性测试方法浅析

Analysis of the Usability Test Method of Home Radiofrequency Beauty Equipment

本文主要根据国家药品监督管理局医疗器械技术审评中心2024年3月19日发布的《医疗器械可用性工程注册审查指导原则》内容对射频美容设备展开可用性评估,描述家用射频美容设备的可用性工程过程以及人机交互的过程,主要包括可用性分析活动、可用性设计活动、可用性实现活动、可用性验证活动、可用性确认活动、可用性更改活动等过程,重点描述家用射频美容设备的可用性评估基本要素。

This paper mainly conducts usability analysis of radiofrequency beauty equipment according to the content of the Guidelines for the Registration and Review of Medical Device Usability Engineering,describes the usability engineering process and human-computer interaction process of household radiofrequency beauty equipment,which mainly include usability analysis activities,usability design activities,usability realization activities,usability verification activities,usability confirmation activities,usability change activities and other processes,and focuses on the basic elements of the usability evaluation of home radiofrequency beauty equipment.