医用电气设备 第2-79部分：通气支持设备的基本安全和主要性能的特殊要求（ISO 80601-2-79:2024）

[中文适用范围]： 注1 此子条款的指导或理由包含在AA.2 条款中。本文件适用于201.3.302中定义的通气支持设备的基本安全和基本性能，以及201.3.300中定义的因通气受损的情况，在此之后也称为ME设备及其附件：—— 旨在用于家庭医疗保健环境；注2 在家庭医疗保健环境中，驱动通气支持设备的电源供应通常不可靠。注3 这样的通气支持设备也可以在专业医疗机构中使用。—— 由非专业人士操作；—— 用于有通气受损的患者，其中最脆弱的患者在这种人工通风丢失的情况下不太可能受到伤害；并且—— 不是依赖人工通风进行立即生命支持的患者的设备。示例1 轻度至中度慢性阻塞性肺病（COPD）患者。除非使用生理学患者变量来调整人工通气治疗设置，否则不认为通气支持设备使用生理闭合回路控制系统。本文件也适用于制造商旨在连接到通气支持设备的呼吸系统的附件，这些附件的特性可以影响通气受损情况下的通气支持设备的基本安全或基本性能。示例2 呼吸装置、连接器、水阱、呼气阀、加湿器、呼吸系统过滤器、外部电源、分布式警报系统。如果某条款或子条款仅旨在适用于ME设备或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，该条款或子条款同时适用于ME设备和ME系统，视具体情况而定。本文件未涵盖此文件范围内ME设备或ME系统的预期生理功能固有的危险，除非在IEC 60601-1:2005+AMD1:2012+AMD2:2020的7.2.13和8.4.1中。注4 可以在IEC 60601-1:2005+AMD1:2012+AMD2:2020的4.2中找到更多相关信息。注5 查阅ISO/TR 21954以获得为特定患者选择适当呼吸机的指导。本文件未规定以下要求：—— 用于重症监护应用的通气机或通气依赖患者的附件，其要求在ISO 80601-2-12中给出；—— 用于麻醉应用的通气机或附件，其要求在ISO 80601-2-13中给出；—— 用于紧急医疗服务环境的通气机或附件，其要求在ISO 80601-2-84中给出；—— 用于家庭医疗保健环境中通气依赖患者的通气支持设备或附件，其要求在ISO 80601-2-72中给出；—— 用于通气不足情况的通气支持设备或附件，其要求在ISO 80601-2-80中给出；—— 呼吸暂停疗法ME设备，其要求在ISO 80601-2-70中给出；—— 高频喷射通气机（HFJV），其要求在ISO 80601-2-87中给出；—— 高频振荡通气机（HFOV）；—— 呼吸高流量设备，其要求在 [外文原描述]： NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2. This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory impairment, as defined in 201.3.300, hereafter also referred to as ME equipment, in combination with its accessories: - intended for use in the home healthcare environment; NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable. NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities. - intended for use by a lay operator; - intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and - not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD). Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. 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 4 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2. NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. This document does not specify the requirements for: - ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; - ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13; - ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84; - ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72; - ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80; - sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70; - high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87; - high-frequency oscillatory ventilators (HFOVs); - respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. - user-powered resuscitators, which are given in ISO 10651-4; - gas-powered emergency resuscitators, which are given in ISO 10651-5; - oxygen therapy constant flow ME equipment; and - cuirass or “iron-lung” ventilation equipment.