角膜移植显微手术机器人系统的安全分析

Safety Analysis of Cornea Grafting Microsurgery Robot System

为了保证显微手术机器人系统的可靠性和安全性,提出了将危险识别、安全保证控制的系统分析法及故障树分析法用于系统的设计过程中.研究了如何针对机器人手术过程、手术环境和医生的手术动作的要求,通过系统需求分析、危险识别、安全保证控制、安全临域界定、安全监控、安全确认、制定系统日志和文档7个有序步骤指导系统的设计,并通过故障树和故障函数对设计结果做全面的分析.样机实验表明,这两种方法的结合为角膜移植手术机器人的可靠性和安全性提供了可靠的保证.

In order to guarantee the reliability and security of the microsurgery robot system, the idea of applying the HISIC (hazard identification and safety insurance control) and FTA (fault tree analysis) safety analysis methods to the system design is put forward. According to the demand of surgery environment and surgical operation, the authors make the research on how to use the following sequence: system demand analysis, hazard identification, safety insurance control, safety critical limits, satety monitoring control, verification and validation, system log and documents as the guide of the system design, and also make the research on how to use the fault tree and fault function to analyze the conclusion of design. The experiment of the prototype machine manifests that the two method' s integration can guarantee the reliability and security of the cornea grafting microsurgery robot system.