医疗器械 第2-80部分：通气不足时通气支持设备的基本安全和主要性能特殊要求（ISO 80601-2-80:2024）

[中文适用范围]： 注1 本子条款的相关指导或理由包含在AA.2条中。本文件适用于201.3.302定义的通风支持设备的基本安全和基本性能，以及在此范围内的通气不足，在通气不足的情况下也称为ME设备，连同其附件：——旨在用于家庭医疗环境；注2 在家庭医疗环境中，驱动通风支持设备的供电线路通常不可靠。注3 这样的通风支持设备也可以在专业医疗机构中使用。——旨在由非专业人士操作；——旨在用于通气不足或失败的患者，其中最脆弱的患者可能会因为失去这种人工呼吸而受伤；——旨在用于转运操作；和——不适用于依赖人工呼吸进行即时生命支持的患者。示例1 中度至重度慢性阻塞性肺病（COPD）患者、中度肌萎缩侧索硬化症（ALS）患者、严重支气管肺发育不良或肌肉萎缩症患者。除非使用生理学患者变量来调整人工通气治疗设置，否则通风支持设备不被视为使用生理性闭环控制系统。本文件也适用于制造商旨在连接到通风支持设备的呼吸系统附件以用于通气不足的情况，其中这些附件的特点可能会影响通风支持设备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、分布式报警系统。如果某条款或子条款特别意图仅适用于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，该条款或子条款既适用于ME设备也适用于ME系统，具体适用情况而定。本文件未涵盖本文件范围内ME设备或ME系统的固有危险，除非在IEC 60601-1：2005+AMD1：2012+AMD2：2020, 7.2.13和8.4.1中特别要求。注4 另外的信息可以在IEC 60601-1：2005+AMD1：2012+AMD2：2020, 4.2中找到。注5 查阅ISO/TR 21954以获得针对特定患者选择合适呼吸机的指导。 本文件不规定以下要求：——旨在用于重症监护应用的人工呼吸或附件，这些要求在ISO 80601-2-12中给出；——旨在用于麻醉应用的人工呼吸或附件，这些要求在ISO 80601-2-13中给出；——旨在用于紧急医疗服务环境中的人工呼吸或附件，这些要求在ISO 80601-2-84中给出；——旨在用于家庭医疗环境中依赖人工呼吸的患者的人工呼吸或附件，这些要求在ISO 80601-2-72中给出；——旨在用于通气障碍的人工呼吸支持设备或附件，这些要求在ISO 80601-2-79中给出；——睡眠呼吸暂停疗法ME设备，这些要求在ISO 80601-2-70中给出；——高频喷射人工呼吸机 [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 insufficiency, as defined in 201.3.302, 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 insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; - intended for transit-operable use; and - not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy. 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 ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency. 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 impairment, which are given in ISO 80601‑2‑79; - 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.