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医用手术机器人可用性测试现状调研

郑勇 孟祥峰 李澍 张超 王浩

中国医疗设备2025,Vol.40Issue(6):1-6,6.
中国医疗设备2025,Vol.40Issue(6):1-6,6.DOI:10.3969/j.issn.1674-1633.20240869

医用手术机器人可用性测试现状调研

Research on the Current Situation of Usability Testing for Medical Surgical Robots

郑勇 1孟祥峰 2李澍 2张超 2王浩2

作者信息

  • 1. 沈阳药科大学 医疗器械学院,辽宁 沈阳 117004||中国食品药品检定研究院 医疗器械检定所,北京 102629
  • 2. 中国食品药品检定研究院 医疗器械检定所,北京 102629
  • 折叠

摘要

Abstract

Objective Based on current status of usability testing of medical surgical robots in China,to explore the common perceptions of enterprises,clinical practitioners and testing agencies regarding the usability testing of surgical robots,and to compare the differences in their needs and concerns regarding usability testing,aiming to provide reference for the formulation of usability testing standards.Methods According to the general requirements of medical device regulation on usability,questionnaires were designed based on factors such as usability testing needs and experimental processes.Data were analyzed to explore on the differences and consensus revealed by common questions among different respondents regarding the usability of different types of surgical robots.Results Analysis of the 60 collected questionnaires revealed that all respondents emphasized the fundamental role of surgical instruments and the necessity of simulating the surgical environment,identifying the completion rate of surgical tasks as a key objective indicator.There were significant differences in the usability testing of different types of surgical robots in terms of auxiliary equipment needs,the role of auxiliary equipment and key objective indicators,with variations in experimental design.Conclusion This study investigated the current status of usability testing of medical surgical robots in China and revealed the common perceptions of different respondents and the specific needs of various types of surgical robots in testing through multi-level analysis.It provides scientific evidence for the formulation of unified testing standards and helps promote the application and development of surgical robots in the medical field.

关键词

医用手术机器人/可用性测试/医疗器械监管/人因工程

Key words

medical surgical robot/usability testing/medical device regulation/human factors engineering

分类

预防医学

引用本文复制引用

郑勇,孟祥峰,李澍,张超,王浩..医用手术机器人可用性测试现状调研[J].中国医疗设备,2025,40(6):1-6,6.

基金项目

国家重点研发计划(2022YFC2409601). (2022YFC2409601)

中国医疗设备

1674-1633

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