医用电气设备.第2-49部分:多功能病人监测设备的基本安全性和必要性能的详细要求

[中文适用范围]： 替换：本特定标准适用于 201.3.63@ 中定义的多功能患者监护设备（以下简称 ME 设备）的基本安全和基本性能要求。该特定标准适用于在医院环境以及在医院环境之外使用的 ME 设备，例如救护车和航空运输。用于医院环境@之外的极端或不受控制的环境条件下（例如救护车和航空运输@）的ME设备应符合此特定标准。附加标准可能适用于这些使用环境的 ME 设备。本标准的范围仅限于用于连接具有两个或多个应用部件或应用部件上具有多功能的单个患者的 ME 设备。该标准没有规定ECG@有创压力和脉搏血氧饱和度等单独监测功能的要求。与这些生理参数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设备@相关的差异，因为此类设备比该独立 ME 设备具有更广泛的预期用途。 [外文原描述]： IEC 60601-2-49:2011 applies to the basic safety and essential performance requirements of multifunction patient monitoring equipment. It applies to medical electrical equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Medical electrical equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to me equipment for those environments of use. The scope of this standard is restricted to medical electrical equipment intended for connection to a single patient that has either two or more applied parts or multiple functions on an applied part. This second edition cancels and replaces the first edition of IEC 60601-2-49, published in 2001. This edition constitutes a technical revision to the new structure of IEC 60601-1:2005 (third edition).