范围:本国际标准适用于伽玛射线治疗设备的基本安全和基本性能，包括多源立体定向放射治疗设备，以下简称ME设备。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）。除通用标准第7.2.13条和第8.4.1条外，本标准的具体要求不包括本标准范围内医用电气设备或医用电气系统预期生理功能的固有危险。本特定标准的目的是为伽玛射线治疗设备制定特定的基本安全和基本性能要求。

Scope:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of GAMMA BEAM THERAPY EQUIPMENT, including MULTI-SOURCE STEREOTACTIC RADIOTHERAPY equipment, hereafter referred to as ME EQUIPMENT.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.HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for GAMMA BEAM THERAPY EQUIPMENT.