[Research on Quality Control Testing Methods for Laparoscopic Surgical Robots]

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.