更换范围:本特殊标准适用于201.3.63中定义的多功能患者监护设备（以下简称医用电气设备）的基本安全和基本性能要求。本特殊标准适用于医院环境中使用的医用电气设备，以及在医院环境外使用的医用电气设备，如救护车和空运设备。医用电气设备拟在医院环境以外的极端或非受控环境条件下使用，如救护车和航空运输中，应符合本特殊标准。 其他标准可能适用于这些使用环境中的医用电气设备。本标准的范围仅限于用于连接单个患者的医用电气设备，该患者具有两个或多个应用部件或应用部件上的多个功能。本标准未规定ECG、有创血压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殊标准从独立医用电气设备的角度规定了要求。由于多功能患者监护设备的预期用途比该支架更广泛，因此本特定标准阐述了与多功能患者监护设备相关的差异- 独自一人给我装备。

ScopeReplacement:This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63, hereafter referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport.ME 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 ME EQUIPMENT intended for connection to a single PATIENT that has either two or more APPLIED PARTS or MULTIPLE FUNCTIONS on an APPLIED PART.This standard does not specify requirements for individual monitoring functions such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological parameters specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the differences related to MULTIFUNCTION PATIENT MONITORING EQUIPMENT, since such equipment has a broader INTENDED USE than this stand-alone ME EQUIPMENT.