ISO 80601-2-90:2021 医用电气设备 第2-90部分：呼吸高流量治疗设备基本安全和基本性能的特殊要求

标准编号：ISO 80601-2-90:2021

中文名称：医用电气设备 第2-90部分：呼吸高流量治疗设备基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment — Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment

发布日期：2021-08

标准范围

本文件适用于201.3.220中定义的呼吸高流量治疗设备（以下也称为ME设备或ME系统）及其附件的基本安全性和基本性能:-拟用于可自主呼吸的患者；和-预期用于将受益于改善的肺泡气体交换的患者；以及谁将受益于接受高流量加湿呼吸气体，这可以包括其上气道被旁路的患者。实施例1表现出动脉血氧合减少的1型呼吸衰竭患者。实施例2根据动脉二氧化碳高的2型呼吸衰竭的需要，将受益于减少呼吸功的患者。实施例3需要湿化以改善粘膜纤毛清除的患者。呼吸高流量治疗设备可以预期用于家庭保健环境或预期用于专业保健设施。注1在家庭医疗保健环境中，电源通常不可靠。呼吸高流量治疗设备可以是:-完全集成的ME设备；或-形成ME系统的单独项目的组合。本标准也适用于其他类型的呼吸设备，当该设备包括呼吸高流量治疗模式时。注2本标准和ISO 80601-2-12[14]适用于具有高流量治疗模式的重症监护呼吸机。呼吸高流量治疗设备可以是可运输操作的。本文件也适用于制造商打算连接到呼吸高-流量治疗设备，其中这些附件的特性会影响呼吸高流量治疗设备的基本安全性或基本性能。实施例4呼吸器、连接器、加湿器、呼吸系统过滤器、外部电源、分布式报警系统、高流量鼻插管、气管导管、气管造口术导管、面罩和喉上气道。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，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。本文件范围内的医用电气设备或医用电气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，通用标准7除外。2.13和8.4.1。注3其他信息见通用标准4.2。本文件未规定以下方面的要求:-ISO 80601中给出的用于危重护理应用的依赖呼吸机的患者的呼吸机或附件？2？12[14];-ISO 80601中规定的用于麻醉应用的呼吸机或附件？2？13[15];-ISO 80601中规定的用于紧急医疗服务环境的呼吸机或附件？2？84[20];-ISO 80601中规定的用于家庭医疗环境中依赖呼吸机的患者的呼吸机或附件？2？72[17];-ISO 80601中给出的用于通气障碍患者的通气支持设备或附件？2？79[18];-ISO 80601中给出的用于通气功能不全患者的通气支持设备或附件？2？80[19];-睡眠呼吸暂停治疗ME设备，ISO 80601？2？70[16];-持续气道正压通气(CPAP)ME设备；-高频喷射通风机（HFJV）[31]，ISO 80601？2？87[21];-医用气体混合器，其在ISO 11195[9]中给出；-流量计，其在ISO 15002[11]中给出；-高频振荡呼吸机（HFOV），ISO 80601？2？87[21];和-胸甲或“铁肺”通气设备。本文件是IEC 60601系列、IEC 80601系列和ISO 80601系列中的特定标准。

This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories:
- intended for use with patients who can breathe spontaneously; and
- intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed.
EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.
EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance.
Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities.
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
Respiratory high-flow therapy equipment can be:
- fully integrated ME equipment; or
- a combination of separate items forming a ME system.
This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.
NOTE 2 This standard and ISO 80601-2-12[14] are applicable to a critical care ventilator with a high-flow therapy mode.
Respiratory high-flow therapy equipment can be transit-operable.
This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.
EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway.
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 the general standard, 7.2.13 and 8.4.1.
NOTE 3 Additional information can be found in the general standard, 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[14];
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601？2？13[15];
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601？2？84[20];
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601？2？72[17];
- ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601？2？79[18];
- ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601？2？80[19];
- sleep apnoea therapy ME equipment, which are given in ISO 80601？2？70[16];
- continuous positive airway pressure (CPAP) ME equipment;
- high-frequency jet ventilators (HFJVs)[31], which are given in ISO 80601？2？87[21];
- gas mixers for medical use, which are given in ISO 11195[9];
- flowmeters, which are given in ISO 15002[11];
- high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601？2？87[21]; and
- cuirass or “iron-lung” ventilation equipment.
This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.

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