医用电气设备 第2-49部分：多功能病人监护设备基本安全和基本性能的特殊要求

[中文适用范围]： 80601 国际标准的这一部分适用于 201.3.201@ 中定义的多功能患者监护仪（以下称为 ME 设备或医疗电气系统）的基本安全和基本性能要求。该特定标准适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中使用的多功能患者监护仪。本文件的范围仅限于用于连接具有两个或多个生理监测单元的单个患者的 ME 设备或医疗电气系统。注：就本文件而言，怀孕的母亲及其胎儿被视为单个患者。本文件没有规定单独的生理监测装置的要求，例如 ECG@ 有创压力和脉搏血氧饱和度。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。示例 1 集成到重症监护呼吸机中的多功能患者监护仪，其中 ISO 80601-2-12 也适用。示例2 多功能患者监护仪并入用于受抚养患者的家庭护理呼吸机，其中ISO 80601-2-72也适用。示例3 并入麻醉工作站的多功能患者监视器，其中ISO 80601-2-13也适用。实施例4 合并到血液透析设备中的多功能患者监视器@ IEC 60601-2-16也适用。本文件不适用于多功能患者监护仪的植入部件。 [外文原描述]： 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.