标准摘要
[中文适用范围]: IEC 60601-2-2:2017 RLV 包含官方 IEC 国际标准及其红线版本。 Redline 版本仅提供英文版本,为您提供了一种快速、简单的方法来比较官方 IEC 标准与其先前版本之间的所有更改。 IEC 60601-2-2:2017 适用于高频手术设备和高频手术配件的基本安全和基本性能。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)不受此特定标准的某些要求的约束。这些豁免在相关要求中有所说明。该特定标准的目的是为高频手术设备和高频手术配件制定特定的基本安全和基本性能要求。本第六版取消并取代了 2009 年发布的第五版。本版本构成了技术修订。相对于前一版本,本版本包括以下重大技术变更: - 定义术语的细化和补充; - 对高频手术设备和高频手术配件的要求进行了额外的区分; ——成人中性电极的新要求为接触质量监测中性电极; - 对具有或使用高电流模式的设备的新要求。 [外文原描述]: IEC 60601-2-2:2017 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 60601-2-2:2017 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.
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