+AMD1:2024 CSV 医用电气设备 第2-49部分：多功能病人监护仪基本安全和基本性能的特殊要求

[中文适用范围]： 本部分 IEC 80601 国际标准适用于作为医疗设备或医疗电气系统定义的多功能患者监护仪的基本安全和基本性能要求。本特定标准适用于旨在用于专业医疗保健设施、急救医疗服务环境以及家庭医疗保健环境的多功能患者监护仪。本文件的范围限于旨在连接单个患者的医疗设备或医疗电气系统，该患者具有两个或更多生理监测单元。注：就本文件而言，孕妇及其胎儿被视为单个患者。本文件未规定心电图、侵入式血压和脉搏血氧仪等各个生理监测单元的要求。与这些生理监测单元相关的特定标准从独立医疗设备的角度规定了要求。本特定标准解决了与多功能患者监护仪相关的额外要求。多功能患者监护仪可集成到其他医疗设备或医疗电气系统中。当这种情况发生时，其他相关标准也适用。 [外文原描述]： IEC 80601-2-49:2018+AMD1:2024 CSV 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.