标准摘要
[中文适用范围]: 本专用标准规定了医疗实践中使用的高频手术设备和高频手术配件(如 2.1.110 中定义,以下简称高频手术设备)的安全要求。额定输出功率不超过 50 W 的高频手术设备(例如用于微凝固,或用于牙科或眼科)不受本专用标准的某些要求的约束。这些豁免在相关要求中有所说明。 [外文原描述]: This Particular Standard specifies requirements for the safety of high frequency surgical equipment and hf surgical accessories used in medical practice. hf surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this Particular Standard. These exemptions are indicated in the relevant requirements.
英文名称Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment