标准摘要
[中文适用范围]： 该部分标准是IEC 60601的一般标准的特殊要求，适用于基本安全和基本性能的高频手术设备和及其附件。它规定了在操作过程中获得实际安全程度的特殊要求。该标准适用于具有额定输出功率超过50W的高频手术设备（例如微型手术设备）。该标准的对象是基本安全和基本性能的高频手术设备和高频手术附件。 [外文原描述]： IEC 60601-2-2:2017+AMD1:2023 CSV applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories. 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. The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - refinement and additions to the defined terms; - additional separation of the requirements for HF surgical equipment and HF surgical accessories; - a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes; - new requirements for devices that have or use a high current mode. The content of the interpretation sheet 1 of the amendment 1 (2025-11) has been included in this copy.
英文名称Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories