ISO 80601-2-79:2018 医用电气设备 第2-79部分： 呼吸障碍辅助设备的基本安全性和基本性能的特殊要求

标准编号：ISO 80601-2-79:2018

中文名称：医用电气设备 第2-79部分： 呼吸障碍辅助设备的基本安全性和基本性能的特殊要求

英文名称：Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

发布日期：2018-07

标准范围

本文件适用于201.3.205中定义的通气支持设备的基本安全和基本性能，以及201.3.202中定义的通气损伤，以下简称医用电气设备及其附件:-用于家庭医疗环境；-供非专业操作人员使用；和-用于有通气障碍的患者，这些患者中最脆弱的，不太可能因失去这种人工通气而受伤；和-不适用于依靠人工通气获得即时生命支持的患者。例1轻中度慢性阻塞性肺疾病（COPD）患者。注1:在家庭医疗环境中，供电干线通常不可靠。注2:此类通风支持设备也可用于非通风设备-专业医疗机构的重症监护应用。本文件也适用于制造商拟连接到通气障碍通气支持设备呼吸系统的附件，这些附件的特性可能会影响通气障碍通气支持设备的基本安全或基本性能。例2呼吸装置、连接器、存水弯、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3:更多信息见IEC 60601-1:2005+AMD1:2012，4.2。本文件未规定以下要求:-ISO 80601？2？12中给出的用于危重病护理应用的呼吸机依赖患者的呼吸机或附件；-ISO 80601？2？13[4]中给出的用于麻醉应用的呼吸机或附件；-用于紧急医疗服务环境的呼吸机或配件，如ISO 80601？2？84[5][1]所示，是ISO 10651？3[6]的未来替代品；-ISO 80601？2？72中给出的用于家庭医疗环境中依赖呼吸机的患者的呼吸机或配件；-ISO 80601？2？80[1]中给出的用于通气不足的通气支持设备或附件；-ISO 80601？2？70[7]中给出的睡眠呼吸暂停治疗医用电气设备；-持续气道正压通气（CPAP）医用设备；-高频喷射通风机（HFJV）；-高频振荡呼吸机（HFOV）[8]；-氧疗恒流医用电气设备；-铁甲或“铁肺”通风设备。本文件是IEC 60601和IEC/ISO 80601系列文件中的文件。[1] 正在准备中。出版时的阶段:ISO/DIS 80601-2-84:2017。

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories:— intended for use in the home healthcare environment;— intended for use by a lay operator; and— 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).NOTE 1 In the home healthcare environment, the supply mains is often not reliable.NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities.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, 7.2.13 and 8.4.1.NOTE 3 Additional information can be found in IEC 60601？1:2005+AMD1:2012, 4.2.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[4];— ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601？2？84 [5] [1], the future replacement for ISO 10651？3[6];— 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[1];— sleep apnoea therapy me equipment, which are given in ISO 80601？2？70[7];— continuous positive airway pressure (CPAP) me equipment;— high-frequency jet ventilators (HFJVs);— high-frequency oscillatory ventilators (HFOVs)[8];— oxygen therapy constant flow me equipment;— cuirass or "iron-lung" ventilation equipment.This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents.[1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

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