Abstract:
To address the lack of quality and safety evaluation standards and the non-uniformity 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 the risk points of 21 core indicators, such as leakage current and horizontal and vertical resolution, and combining with standards such as GB
9706.1 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 7 devices of different brands in 3 institutions. The 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 potential quality issues of the devices. This system fills the gap in the quality evaluation standards for laparoscopic surgical robots, providing standardized tools for hospital acceptance, daily quality control, and health supervision, and promoting the industrialization and standardization of domestic equipment.