IEC 60601-2-2:2017 RLV
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
发布时间:2017-03-31 实施时间:


高频手术设备和高频手术附件是医疗电气设备中的一类,主要用于手术中的切割、凝固和切割凝固等操作。这些设备在手术中起到至关重要的作用,因此其安全性和性能要求非常高。IEC 60601-2-2:2017 RLV就是为了规范这些设备的基本安全和基本性能而制定的。

该标准规定了高频手术设备和高频手术附件的基本安全和基本性能的特殊要求。其中,基本安全包括电气安全、机械安全、火灾安全、化学安全、生物安全和环境安全等方面;基本性能包括输出功率、输出频率、输出波形、输出模式、输出控制、输出监测、输出指示和输出保护等方面。这些要求旨在确保高频手术设备和高频手术附件在使用过程中不会对患者和医护人员造成伤害,并能够正常、稳定地工作。

除了基本安全和基本性能的要求外,IEC 60601-2-2:2017 RLV还规定了高频手术设备和高频手术附件的其他要求,如标识、说明书、维护和保养、环境适应性、电磁兼容性等。这些要求也是为了确保高频手术设备和高频手术附件能够在各种环境下正常工作,并且能够被正确地使用和维护。

总之,IEC 60601-2-2:2017 RLV是一项非常重要的医疗电气设备标准,它规定了高频手术设备和高频手术附件的基本安全和基本性能的特殊要求,为这些设备的设计、制造和测试提供了指导和规范。

相关标准
- IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of oscopic equipment
- IEC 60601-2-41:2010 Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
- IEC 60601-2-46:2017 Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
- IEC 60601-2-49:2014 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment