ISO 80601-2-74:2021 医用电气设备 第2-74部分：呼吸增湿设备基本安全和基本性能的特殊要求

标准编号：ISO 80601-2-74:2021

中文名称：医用电气设备 第2-74部分：呼吸增湿设备基本安全和基本性能的特殊要求

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：2021-07

标准范围

本文件适用于加湿器（以下也称为ME设备）及其附件（以下也称为ME系统）的基本安全和基本性能。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。实施例1加热呼吸管（热线呼吸管）或用于控制这些加热呼吸管的ME设备（加热呼吸管控制器）。注1加热呼吸管及其控制器属于ME设备，应符合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。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。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。实施例2结合到重症监护呼吸机中的加热加湿器，其中ISO 80601-2-12[10]也适用。实施例3结合到用于依赖患者的家庭护理呼吸机中的加热加湿器，其中ISO 80601-2-72[12]也适用。实施例4结合到睡眠呼吸暂停治疗设备中的加热加湿器，其中ISO 80601-2-70[11]也适用。实施例5结合到通风支持设备中的加热加湿器，其中ISO 80601-2-79[13]或ISO 80601-2-80[14]也适用。实施例6结合到呼吸高流量治疗设备中的加热加湿器，其中ISO 80601-2-90[15]也适用。本文件还包括对主动HME（热湿交换器）的要求，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ME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。注4 ISO 9360-1和ISO 9360-2[4]规定了被动HME的安全和性能要求。注5:如果某条款或子条款特别打算仅适用于ME设备，或仅适用于ME系统，则该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。除IEC 60601-1:20 05+AMD1:2012+AMD2:2020、7.2.13和8.4.1中的规定外，本文件范围内的ME设备或ME系统预期生理功能中固有的危害不在本文件的具体要求范围内。注6其他信息见IEC 60601-1:20 05+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]给出了这些要求。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。注7 ISO 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.

标准预览图