适用于机器人辅助手术设备（RASE）和机器人辅助手术系统（RASS）的基本安全和基本性能，称为医用电气设备和医用电气系统及其接口条件。本特殊标准不适用于基于X射线的图像引导放射治疗设备。本标准的具体要求不包括本标准范围内医用电气设备预期生理功能所固有的危险。

Applies to the basic safety and essential performance of robotically assisted surgical equipment (RASE) and robotically assisted surgical systems (RASS), referred to as ME equipment and ME systems together with their interface conditions. This particular standard does not apply to X-ray-based image-guided radiotherapy equipment. Hazards inherent in the intended physiological function of ME equipment within the scope of this standard are not covered by specific requirements in this standard.