ISO 80601-2-74:2017 医用电气设备 第2-74部分：呼吸加湿设备特定基本安全要求和重要性能

标准编号：ISO 80601-2-74:2017

中文名称：医用电气设备 第2-74部分：呼吸加湿设备特定基本安全要求和重要性能

英文名称：Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

发布日期：2017-05

标准范围

ISO 80601-2-74:2017适用于加湿器（以下简称me设备）及其附件（以下简称me系统）的基本安全和基本性能。ISO 80601-2-74:2017也适用于制造商计划连接到加湿器的附件，这些附件的特性可能会影响加湿器的基本安全或基本性能。示例1加热型呼吸管（加热型钢丝呼吸管）或医用电气设备，用于控制这些加热型呼吸管（加热型呼吸管控制器）。注1:加热式呼吸管及其控制器是医用电气设备，符合IEC 60601-1的要求。注2:ISO 5367规定了呼吸管的其他安全和性能要求。ISO 80601-2-74:2017包括湿化的不同医疗用途的要求，如有创通气、无创通气、鼻腔高流量治疗、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。注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2将加热型加湿器并入重症监护呼吸机中，ISO 80601？2-12[12]也适用。例3:ISO 80601-2规定的家庭护理呼吸机中的加热加湿器-72[14]也适用。例4将加热型加湿器并入睡眠呼吸暂停治疗设备中，ISO 80601？2-70[13]也适用。ISO 80601-2-74:2017还包括对主动hme（热湿交换器）的要求，即主动添加热量和水分以增加从hme输送至患者的气体湿度水平的医用电气设备。本文件不适用于被动hme，被动hme在吸气期间将患者的一部分过期水分和热量返回呼吸道，而不增加热量或水分。注4:ISO 9360-1[5]和ISO 9360-2[6]规定了被动hme的安全和性能要求。如果某一条款或子条款明确规定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和内容应如此说明。如果情况并非如此，则本条款或子条款适用于医用电气设备和医用电气系统（视情况而定）。除IEC 60601-1:2005+AMD1:2012、7.2.13和8.4.1外，本文件的具体要求未涵盖本文件范围内医用电气设备或医用电气系统预期生理功能中固有的危险。注5:更多信息见IEC 60601-1:2005+AMD1:2012，4.2。ISO 80601-2-74:2017未规定冷传递或冷气泡通过加湿装置的要求，其要求见ISO 20789:？。[8]本文件不适用于通常称为“房间加湿器”的设备，或用于供暖、通风和空调系统的加湿器，或并入婴儿孵化器的加湿器。ISO 80601-2-74:2017不适用于用于向患者输送药物的雾化器。注6:ISO 27427[10]规定了雾化器的安全和性能要求。ISO 80601-2-74:2017是IEC 60601-1和ISO/IEC 80601系列中的特殊标准。

ISO 80601-2-74:2017 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.ISO 80601-2-74:2017 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.ISO 80601-2-74:2017 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[12] also applies.EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601？2-72[14] also applies.EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601？2-70[13] also applies.ISO 80601-2-74:2017 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[5] and ISO 9360？2[6] specify the safety and performance requirements for a passive hme.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, 7.2.13 and 8.4.1.NOTE 5 Additional information can be found in IEC 60601？1:2005+AMD1:2012, 4.2.ISO 80601-2-74:2017 does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789:?.[8]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.ISO 80601-2-74:2017 is not applicable to nebulizers used for the delivery of drugs to patients.NOTE 6 ISO 27427[10] specifies the safety and performance requirements for nebulizers.ISO 80601-2-74:2017 is a particular standard in the IEC 60601？1 and the ISO/IEC 80601 series.

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