腔镜手术机器人的质量控制检测方法研究

      Research on Quality Control Testing Methods for Laparoscopic Surgical Robots

      • 摘要: 为解决腔镜手术机器人临床应用中质量安全评价标准缺失、检测方法不统一的问题,该研究基于“设备外观及功能-电气安全-图像质量-机械臂和手术器械”四维框架,制定科学可操作的测试方法体系。通过梳理21项核心指标的风险点,如漏电流、水平垂直分辨率等,结合YY/T 1712—2021等标准确定测试原理,明确各指标测试工具、操作步骤及限值,并在3家机构、不同品牌的7台设备上开展多中心验证。结果显示,测试方法在不同设备间的可操作性超过90%,指标合格率>77%,能有效识别设备质量隐患。该体系填补了腔镜手术机器人应用质量评价的标准空白,可为医院验收、日常质量控制及卫生监督提供标准化工具,助力国产设备产业化与行业规范化发展。

         

        Abstract: To address the lack of quality and safety evaluation criteria and the inconsistency of testing methods in the clinical application of laparoscopic surgical robots, this study developed a scientific and operable testing method system based on a four-dimensional framework of "device appearance and function-electrical safety-image quality-robotic arm and surgical instruments". By identifying risk points of 21 core indicators, such as leakage current and horizontal/vertical resolution, and referencing standards such as YY/T 1712—2021 to determine the testing principles, the testing tools, operation steps, and limit values for each indicator were clearly defined. Multi-center validation was conducted on seven devices of different brands in three institutions. The validation results showed that the operability of the testing methods across different devices exceeded 90%, and the qualification rate of indicators was over 77%, effectively identifying latent device quality deficiencies. This system addresses a critical gap in the applied quality evaluation of laparoscopic surgical robots, providing standardized tools for hospital acceptance, daily quality control, and health supervision, and promoting the industrialization of medical devices and the standardization of the industry.

         

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