本文件适用于高频呼吸机（HFV）及其附件（以下简称医用电气设备）的基本安全和基本性能: 适用于为病情可能危及生命、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； 注1:就本文件而言，这种环境被称为重症监护环境。这种环境下的高频呼吸机被认为是维持生命的。 注2:就本文件而言，如此高的- 高频呼吸机可以在专业医疗设施内提供运输（即，作为运输可操作呼吸机）。 注3:用于专业医疗设施内运输的高频呼吸机不被视为用于紧急医疗服务环境的呼吸机。 拟由医疗专业操作员操作； 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150次以上的充气/分钟。 HFV有三个主要名称: 高频冲击通气[HFPV，典型HFV频率为（60至1000）HFV充气/分钟]；   高频射流通风[HFJV，典型HFV频率为（100至1500）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相]。  此外，HFV标志可以组合在一起，或与通风率低于150次/分钟。 *高频呼吸机不被视为生理闭环控制系统，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拟连接到HFV呼吸系统或高压电缆的附件- 高频呼吸机，其中这些附件的特性可能影响高频呼吸机的基本安全或基本性能。 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。如果不是这样，则本条款或子条款适用于医用电气设备和医用电气系统。 除IEC 60601的7.2.13和8.4.1外，本文件的具体要求不包括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的固有危险- 1:2005. 注4:更多信息见IEC 60601-1:2005+AMD1:2012的4.2。 本文件不适用于仅用于增强专业医疗机构内自主呼吸患者通气的医用电气设备。 本文件未规定以下要求: ISO 80601-2-12[23]中给出的为重症监护环境提供常规通风的非高频通风器或附件；。 注5:HFV可以包括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 806中规定的用于麻醉应用的呼吸机或附件

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 806