行业标准《采用机器人技术的腹腔内窥镜手术系统》解读

Interpretation of the Industry Standard Robotically-assisted Laparoscopic Surgical System

  • 摘要: 随着机器人技术在手术中的广泛应用,多款采用机器人技术的腹腔内窥镜手术系统正处于研发阶段,亟需建立科学规范的质量评价体系。国家药品监督管理局于2024年发布的YY/T 1941-2024《采用机器人技术的腹腔内窥镜手术系统》标准,明确了该类系统的性能要求与测试方法,为该类创新产品的研发、技术推进及监管工作提供了重要依据。该标准对相关术语进行了统一界定,并从手动控制器性能、器械操作臂性能、系统操作性能、安全保护功能、机器人手术器械及软件6个方面规范了该类产品的质量评价方法。本文将对标准中的核心指标进行解读,旨在帮助临床医生深入理解该类产品的各项性能参数,并助力企业更好地开展产品开发阶段的质量评价与风险分析,促进该类产品及行业的高质量发展。

     

    Abstract: With the widespread application of robotic technology in surgery, multiple robot-assisted laparoscopic endoscopic surgical systems are currently in the R&D phase, highlighting an urgent need for establishing a scientific and standardized quality evaluation framework. In 2024, the National Medical Products Administration issued the standard YY/T 1941-2024, entitled Robotically-assisted Laparoscopic Surgical System, which specifies performance requirements and test methods for such systems. This standard provides critical guidance for the development of innovative products, technological advancement, and regulatory oversight. The standard offers clear definitions of relevant terminology and systematically standardizes the quality evaluation methods for these products across six key aspects: manual controller performance, instrument arm performance, system operational performance, safety protection functions, robotic surgical instruments, and software. This article interprets the core indicators outlined in the standard, aiming to assist clinicians in gaining a deeper understanding of the performance parameters of these systems and to support manufacturers in conducting quality assessments and risk analyses during product development, thereby promoting high-quality progress in the industry and related products.

     

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