范围:IEC 80601的本部分适用于机器人辅助外科设备（RASE）和机器人辅助外科系统（RASS）的基本安全和基本性能，以下简称ME设备和ME系统及其交互条件和接口条件。如果某一条款或子条款明确规定仅适用于医用电气设备，或仅适用于医用电气系统，则该条款或子条款的标题和内容应如此说明。如果情况并非如此，则本条款或子条款适用于医用电气设备和医用电气系统（视情况而定）。如果RASE或RASS或其附件属于另一特定标准的范围，则该特定标准适用于本标准之外的其他标准。HF外科设备的IEC 60601-2-2[3]示例；内窥镜设备的IEC 60601-2-18[4]；激光设备的IEC 60601-2-22[5]；超声设备的IEC 60601-2-37[6]；IEC 60601-2-46[7]关于手术台等。 目标:本特定标准的目的是为机器人辅助手术设备和机器人辅助手术系统制定特定的基本安全和基本性能要求。

Scope:This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.If RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the particular standard applies in addition to this standard.EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT; IEC 60601-2-18[4] for ENDOSCOPIC EQUIPMENT; IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 60601-2-46[7] for operating tables, etc.Object: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ROBOTICALLY ASSISTED SURGICAL EQUIPMENT and ROBOTICALLY ASSISTED SURGICAL SYSTEMS.