医用电气设备 第2-74部分：呼吸加湿设备基本安全和基本性能的专用要求 (ISO 80601-2-74:2026)

[中文适用范围]： 本文件适用于加湿器的基本安全与基本性能（后文统称“医用电气设备”），及其配套附件（合称“医用电气系统”）。本文件亦适用于制造商指定连接至加湿器的附件，若该附件的特性可能影响加湿器的基本安全或基本性能。 示例1：加温呼吸管路（加温导线呼吸管路）或用于控制此类加温呼吸管路的医用电气设备（加温呼吸管路控制器）。 注2：加温呼吸管路及其控制器属于医用电气设备，须符合IEC 60601‑1的要求。 注3：ISO 5367规定了呼吸管路的其它安全与性能要求。 本文件涵盖加湿的不同医疗用途的相关要求，包括侵入性通气、非侵入性通气、鼻部高流量治疗及阻塞性睡眠呼吸暂停治疗，以及气管切开术患者的湿化治疗。 注4：加湿器可集成于其他设备中；此时，其他设备的相关要求亦适用于该加湿器。 示例2：集成于危重症呼吸机中的加温加湿器，此时亦适用ISO 80601‑2‑12。 示例3：集成于依赖患者家用呼吸机中的加温加湿器，此时亦适用ISO 80601‑2‑72。 示例4：集成于睡眠呼吸暂停治疗设备中的加温加湿器，此时亦适用ISO 80601‑2‑70。 示例5：集成于通气支持设备中的加温加湿器，此时亦适用ISO 80601‑2‑79或ISO 80601‑2‑80。 示例6：集成于呼吸高流量治疗设备中的加温加湿器，此时亦适用ISO 80601‑2‑90。 本文件亦包含对主动型热湿交换器（HME）的要求，即通过主动加热和加湿以提高从HME输送至患者的气体湿度的医用电气设备。 本文件不适用于被动型HME，后者仅在患者吸气时将部分呼出气体中的水分和热量返还至呼吸道，而不主动添加热量或水分。 注5：ISO 9360‑1和ISO 9360‑2规定了被动型HME的安全与性能要求。 注6：若某条款或子条款明确仅适用于医用电气设备或仅适用于医用电气系统，则该条款或子条款的标题及内容将予以说明；否则，该条款或子条款同时适用于医用电气设备及医用电气系统（视情况而定）。 本文件涵盖范围内，医用电气设备或医用电气系统因其预期生理功能而固有危害，除IEC 60601‑1:2005+AMD1:2012+AMD2:2020中第7.2.13条和第8.4.1条另有规定外，本文件未作具体要求。 注7：更多信息可参见IEC 60601‑1:2005+AMD1:2012+AMD2:2020第4.2条。 本文件未规定冷式旁路或冷式鼓泡式湿化装置的要求，相关要求见ISO 20789。 本文件不适用于通常所称的“房间加湿器”、暖通空调系统中使用的加湿器，或集成于婴儿培养箱中用于对培养箱内部加湿的加湿器。 [外文原描述]： 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 2 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601 ‑ 1 . NOTE 3 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 4 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 also applies. EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑ 2‑72 also applies. EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑ 2‑70 also applies. EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79 or ISO 80601-2-80 also apply. EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑ 2‑90 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 5 ISO 9360 ‑ 1 and ISO 9360 ‑ 2 specify safety and performance requirements for a passive HME. NOTE 6 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 7 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. 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 to humidify the chamber air (i.e., are not directly connected to the patient). This document is not applicable to nebulizers used for the delivery of a drug to patients. NOTE 8 ISO 27427 specifies the safety and performance requirements for nebulizers.