摘要
软组织穿刺手术机器人是精准医疗的关键载体,但其技术复杂性、人机交互依赖性及动态环境适应性使其成为高风险医疗设备。开展DFMEA分析不仅是满足医疗器械安全标准的合规要求,更是预防术中失效、保障患者安全的必由之路。为了在产品设计研发阶段明确系统性风险管控需求,本文依次开展了手术机器人的结构分析、功能分析、失效分析,识别了从硬件到软件的全链条失效。通过建立评价准则实现了风险分析,为制定新的预防性措施、探测性措施提供了依据,对提升产品质量,控制研发成本具有重要实际价值。
Surgical robots for soft tissue puncture are key carriers of precision medicine,but their technical complexity,human-machine interaction dependence,and dynamic environmental adaptability make them high-risk medical equipment.Conducting DFMEA analysis is not only to meet the compliance requirements of medical device safety standards,but also a necessary path to prevent operative failures and ensure patient safety.In order to clarify the systematic risk management requirements during the product design and development phase,the paper conducted structural analysis,functional analysis,and failure analysis of surgical robots in sequence,identifying the full chain failures from hardware to software.By establishing evaluation criteria,risk analysis has been achieved,providing a basis for developing new preventive and exploratory measures,which is of great practical significance for improving product quality and controlling research and development costs.
作者
张鑫
孙振
白艳梅
朱旭营
Zhang Xin;Sun Zhen;Bai Yanmei;Zhu Xuying(Instrumentation Technology and Economy Institute,Beijing 100055)
出处
《仪器仪表标准化与计量》
2025年第4期8-10,共3页
Instrument Standardization & Metrology
基金
国家重点研发计划项目:肺部等软组织穿刺手术机器人的工程化开发(编号:2022YFB4702604)。
关键词
穿刺
手术机器人
导航定位系统
失效
可靠性
Puncture
Surgical Robot
Navigation and Positioning System
Failure
Reliability
