IEC 80601-2-49:2018 多参数病人监护设备委员会电子医疗 病人监护 诊断设备医用电气设备第2-49部分:多功能病人监护机基本安全和基本性能的特殊要求

标准编号：IEC 80601-2-49:2018

中文名称：多参数病人监护设备委员会电子医疗 病人监护 诊断设备医用电气设备第2-49部分:多功能病人监护机基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

发布日期：2018-03-08

标准范围

IEC 80601-2-49:2018适用于多功能患者监护仪（以下简称ME设备或医用电气系统）的基本安全和基本性能要求。本特定标准适用于用于专业医疗机构以及紧急医疗服务环境或家庭医疗环境的多功能患者监护仪。本文件的范围仅限于旨在连接到具有两个或更多生理监测单元的单个患者的ME设备或医疗电气系统。就本文件而言，孕妇及其胎儿被视为单个患者。本文件未规定单个生理监测单元的要求，如ECG、有创压力和脉搏血氧饱和度测定。与这些生理监测单元相关的特定标准从独立ME设备的角度规定了要求。该特定标准解决了与多功能患者监护仪相关的附加要求。多功能患者监护仪可以集成到其他ME设备或医疗电气系统中。在这种情况下，其他相关标准也适用。本文件不适用于多功能患者监护仪的植入部件。第一版取消并取代了2011年发布的IEC 60601-2-49的第二版。本版本为技术修订版，与IEC 60601-1的当前版本和修订版、附属标准的新版本及其修订版保持一致。主要变化在第208条中，因为许多以前的要求现在由IEC 60601-1-8解决。

IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment.
The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units.
For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient.
This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply.
This document does not apply to implantable parts of multifunction patient monitors.
This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8.

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