本文件适用于高频呼吸机（HFV）及其附件（以下简称ME？设备: 旨在为病情可能危及生命且可能需要在专业医疗机构进行全面护理和持续监测的患者提供专业护理的环境中使用； 笔记？1？出于本文件的目的，这种环境被称为重症监护环境。用于这种环境的高频呼吸机被认为是维持生命的。 笔记？2？出于本文的目的，这种高频呼吸机可以在专业医疗机构内提供运输(即，是可运输操作的呼吸机)。 笔记？3？预期用于专业医疗机构内运输的高频呼吸机不被视为预期用于紧急医疗服务环境的呼吸机。拟由医疗保健专业运营商运营； 适用于需要不同程度人工通气支持的患者，包括依赖呼吸机的患者；和 能够提供超过150次/分钟的充气。 HFV有三种主要名称: 高频冲击通气【HFPV，典型的HFV频率为（60至1？000）HFV充气/分钟】；？ 高频喷射通气[HFJV，典型的HFV频率为（100至1？500）HFV充气/分钟]；和 高频振荡通气【HFOV，典型HFV频率为（180至1200）HFV充气/分钟，通常具有活跃的呼气期】。？ 此外，HFV名称可以组合在一起或与通风率低于150？通货膨胀/分钟。*？高频呼吸机不被认为是生理闭环控制系统，除非它使用生理患者变量来调整通气治疗设置。 本文件也适用于制造商打算连接到HFV呼吸系统或高频呼吸机的附件，其中这些附件的特性会影响高频呼吸机的基本安全性或基本性能。 如果某个条款或子条款专门适用于我？只是设备，还是对我来说？仅系统，该条款或子条款的标题和内容会这么说。如果不是这样，该条款或子条款是否同时适用于我？设备和我？相关的系统。 ME预期生理功能中固有的危害？设备还是我？本文件范围内的系统不在本文件中的具体要求范围内，第7条除外。IEC的2.13和8.4.1？60601-1:2005. 笔记？4？更多信息见IEC的4.2？60601-1:2005+AMD1:2012。 这份文件不适用于我？仅用于增强专业医疗机构内自主呼吸患者通气的设备。 本文件未规定以下方面的要求: ISO？80601-2-12？[23];. 笔记？5？HFV可以结合传统的重症监护呼吸机操作模式，在这种情况下，ISO？80601-2-12适用于这些模式。 ISO中规定的用于麻醉应用的呼吸机或附件？80601-2-13？[24]; ISO中规定的用于紧急医疗服务环境的呼吸机或附件？80601-2-84，ISO的替代品？10651-3？[13]; 笔记？6？HFV可以结合EMS呼吸机功能。 ISO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附件？80601？2-72？[26]; ISO中规定的用于家庭护理通气支持设备的呼吸机或附件？80601-2-79？[27]和ISO？80601-2-80？[28]，ISO的替代品？10651-6？[15]; 睡眠呼吸暂停呼吸疗法我？ISO中给出的设备？80601-2-70？[25]; 双水平气道正压通气（双水平PAP）ME？设备； 持续气道正压通气（CPAP）我？设备； 呼吸高流量ME设备，其在ISO 80601-2-90中给出:-1；和 胸甲或“铁肺”通气 这份文件是IEC的一个特殊标准？60601系列，IEC？80601系列和ISO 80601系列。 ？ 1正在准备中。出版时的阶段:ISO/DIS？80601-2-90:2020.

This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME？equipment:

• intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;

NOTE？1？For the purposes of this document, such an environment is referred to as a critical care environment. High-frequency ventilators for this environment are considered life-sustaining. NOTE？2？For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator). NOTE？3？A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment.

• intended to be operated by a healthcare professional operator;
• intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and
• capable of providing more than 150 inflations/min.

There are three principal designations of HFV:

• high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1？000) HFV inflations/min];？
• high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1？500) HFV inflations/min]; and
• high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase].？

Additionally, HFV designations can be combined together or with ventilation at rates less than 150？inflations/min. *？A high-frequency ventilator is not considered a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to an HFV breathing system, or to a high-frequency ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the high-frequency ventilator. 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 7.2.13 and 8.4.1 of IEC？60601-1:2005. NOTE？4？Additional information can be found in 4.2 of IEC？60601-1:2005+AMD1:2012. This document is not applicable to ME？equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for:

• non-high-frequency ventilators or accessories which provide conventional ventilation for use in critical care environments, which are given in ISO？80601-2-12？^[23];.

NOTE？5？An HFV can incorporate conventional critical care ventilator operational modes, in which case ISO？80601-2-12 is applicable to those modes.

• ventilators or accessories intended for anaesthetic applications, which are given in ISO？80601-2-13？^[24];
• ventilators or accessories intended for the emergency medical services environment, which are given in ISO？80601-2-84, the replacement for ISO？10651-3？^[13];

NOTE？6？An HFV can incorporate EMS ventilator capability.

• ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO？80601？2-72？^[26];
• ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO？80601-2-79？^[27] and ISO？80601-2-80？^[28], the replacements for ISO？10651-6？^[15];
• sleep apnoea breathing therapy ME？equipment, which are given in ISO？80601-2-70？^[25];
• bi-level positive airway pressure (bi-level PAP) ME？equipment;
• continuous positive airway pressure (CPAP) ME？equipment;
• respiratory high-flow ME equipment, which are given in ISO 80601-2-90:—¹; and
• cuirass or “iron-lung” ventilation

This document is a particular standard in the IEC？60601 series, the IEC？80601 series and the ISO 80601 series. ？ 1 Under preparation. Stage at the time of publication: ISO/DIS？80601-2-90:2020.