可穿戴康复助行机器人安全性有效性评价要点分析  

Analysis on Key Points of Safety and Effectiveness Evaluation of Wearable Rehabilitation Walking Aid Robot

作　　者：蒋硕 张克 陈一依 张在爱 付丽 郝鹏飞 JIANG Shuo;ZHANG Ke;CHEN Yiyi;ZHANG Zaiai;FU Li;HAO Pengfei(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan,250101;NMPA Key Laboratory for Quality Evaluation of Medical Materials and Biological Protective Devices,Jinan,250101)

机构地区：[1]山东省医疗器械和药品包装检验研究院,济南市250101 [2]国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,济南市250101

出　　处：《中国医疗器械杂志》2023年第2期207-210,共4页Chinese Journal of Medical Instrumentation

基　　金：山东省重大科技创新工程项目(2019JZZY021010)。

摘　　要：目的 分析可穿戴康复助行机器人的安全性有效性评价要点,促进可穿戴康复助行机器人质量控制。方法 结合可穿戴康复助行机器人的功能、结构特点,分别从电气安全、主要性能方面分析质量评价的要点,并对机器人设计开发提出合理化建议。结果 可穿戴康复助行机器人的安全性有效性评价要重点关注电池、保护装置、运行参数、静载强度、网络安全与环境适应性等方面。结论 通过对可穿戴康复助行机器人的安全性有效性评价要点进行分析,为此类产品设计开发提供一定的思路,为完善产品质量评价体系提供参考。Objective To analyze the key points of evaluation on the safety and effectiveness of wearable rehabilitation walking aid robot,then improve its quality control ability.Methods Combined with the functional and structural characteristics of the wearable rehabilitation walking aid robot,the key points of quality evaluation were analyzed from the aspects of electrical safety and main performance.Some reasonable suggestions were put forward for the design and development of the robot.Results The key points of safety and effectiveness evaluation of wearable rehabilitation aid walking robot focused on battery,protection device,operation parameters,static load strength,network security,environmental adaptability and other aspects.Conclusion By analyzing the key points of safety and effectiveness evaluation of wearable rehabilitation walking aid robot,certain ideas are provided for the design and development of such products,and reference is provided for the improvement of product quality evaluation system.

关 键 词：可穿戴 康复机器人 安全性 有效性 质量评价 

分 类 号：F203[经济管理—国民经济]