本文件适用于加湿器的基本安全和基本性能，以下也称为我？设备，连同其附件，该组合在下文中也称为我？系统。 本文件也适用于制造商打算连接到加湿器的附件，其中这些附件的特性会影响加湿器的基本安全性或基本性能。 例子？1？加热呼吸管（热线呼吸管）还是我？用于控制这些加热呼吸管的设备（加热呼吸管控制器）。 笔记？1？加热呼吸管和它们的控制器是我吗？设备，并符合IEC的要求？60601？1. 笔记？2？伊索？5367规定了呼吸管的其他安全和性能要求。本文件包括湿化的不同医疗用途的要求，如有创通气、无创通气、鼻高流量治疗和阻塞性睡眠呼吸暂停治疗，以及气管造口术患者的湿化治疗。 笔记？3？加湿器可以集成到其他设备中。在这种情况下，其他设备的要求也适用于加湿器。 例子？2？加热加湿器集成到重症监护呼吸机中。80601？图2-12[10]也适用。 例子？3？加热加湿器集成到家庭护理呼吸机中，用于依赖患者。80601？2-72[12]也适用。 例子？4？加热加湿器并入睡眠呼吸暂停治疗设备。80601？2？70[11]也适用。 例子？5？加热加湿器结合到通风支持设备中。80601-2-79[13]还是ISO？80601-2-80[14]也适用。 例子？6？加热加湿器结合到呼吸高流量治疗设备中。80601？2？90[15]也适用。 本文档还包括对主动？HME（热湿交换器），我？主动增加热量和水分以增加从HME输送到患者的气体的湿度水平的设备。本文件不适用于被动HME，该被动HME在吸气期间将患者呼出的水分和热量的一部分返回呼吸道，而不增加热量或水分。 笔记？4？伊索？9360？1和ISO？9360？2[4]规定了被动HME的安全和性能要求。 笔记？5？如果某个条款或子条款专门适用于我？只是设备，还是对我来说？仅系统，该条款或子条款的标题和内容会这么说。如果不是这样，该条款或子条款是否同时适用于我？设备和我？相关的系统。 ME预期生理功能中固有的危害？设备还是我？除了IEC？60601？1:20 05+AMD1:2012+AMD2:2020、7.2.13和8.4.1。 笔记？6？更多信息可在IEC？60601？1:2005+AMD1:2012+AMD2:2020，4.2。 本文件没有规定冷通过或冷气泡通过加湿装置的要求，ISO？20789[6]. 本文件不适用于通常称为“室内加湿器”的设备或用于供暖、通风和空调系统的加湿器，或并入婴儿保温箱的加湿器。本文件不适用于用于向患者输送药物的雾化器。 笔记？7？伊索？27427[7]规定了雾化器的安全和性能要求。

This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME？equipment, in combination with its accessories, the combination also hereafter referred to as ME？system. This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier. EXAMPLE？1？Heated breathing tubes (heated-wire breathing tubes) or ME？equipment intended to control these heated breathing tubes (heated breathing tube controllers). NOTE？1？Heated breathing tubes and their controllers are ME？equipment and are subject to the requirements of IEC？60601？1. NOTE？2？ISO？5367 specifies other safety and performance requirements for breathing tubes. This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients. NOTE？3？A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier. EXAMPLE？2？Heated humidifier incorporated into a critical care ventilator where ISO？80601？2-12^[10] also applies. EXAMPLE？3？Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO？80601？2-72^[12] also applies. EXAMPLE？4？Heated humidifier incorporated into sleep apnoea therapy equipment where ISO？80601？2？70^[11] also applies. EXAMPLE？5？Heated humidifier incorporated into ventilatory support equipment where either ISO？80601-2-79^[13] or ISO？80601-2-80^[14] also apply. EXAMPLE？6？Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO？80601？2？90^[15] also applies. This document also includes requirements for an active？HME (heat and moisture exchanger), ME？equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture. NOTE？4？ISO？9360？1 and ISO？9360？2^[4] specify safety and performance requirements for a passive HME. NOTE？5？If a clause or subclause is specifically intended to be applicable to ME？equipment only, or to ME？systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME？equipment and to ME？systems, as relevant. Hazards inherent in the intended physiological function of ME？equipment or ME？systems within the scope of this document are not covered by specific requirements in this document except in IEC？60601？1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE？6？Additional information can be found in IEC？60601？1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO？20789^[6]. This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators. This document is not applicable to nebulizers used for the delivery of a drug to patients. NOTE？7？ISO？27427^[7] specifies the safety and performance requirements for nebulizers.