本文件适用于重症监护呼吸机及其附件的基本安全和基本性能，以下简称ME设备: ¾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2在本文件中，这种环境被称为重症监护环境。这种环境下的通风机被认为是维持生命的。 注3:就本文件而言，此类重症监护呼吸机可在专业医疗机构（即。 e.是可运输操作的通风机）。 注4:用于专业医疗机构内运输的重症监护呼吸机不被视为紧急医疗服务环境呼吸机。 ¾拟由医疗专业运营商运营；和 ¾适用于需要不同水平人工通气支持的患者，包括依赖呼吸机的患者。 重症监护呼吸机不被认为使用生理闭环控制系统，除非它使用生理患者变量来调整人工通气治疗设置。 本文件也适用于制造商计划连接到呼吸机呼吸系统或呼吸机的附件，这些附件的特性可能会影响呼吸机的基本安全或基本性能。 注5:如果某一条款或子条款专门适用于ME设备，或仅适用于ME系统，则该条款或子条的标题和内容将说明这一点。如果不是这样，则该条或子条款同时适用于相关的ME设备和ME系统。 除IEC 60601-1:2005+AMD1:2012+AMD2:2020、7.2.13和8.4.1外，本文件范围内的医用电气设备或医用电气系统的预期生理功能所固有的危险不包括在本文件的具体要求中。 注6附加信息见IEC 60601-1:2005+AMD1:2012+AMD2:2020，4.2。 本文件不适用于在呼吸机中运行的ME设备或ME系统- 仅适用于不依赖人工通气的患者的操作模式。 注7重症监护呼吸机在这种呼吸机运行模式下运行时，不被视为维持生命。 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ME设备。 本文件未规定以下方面的要求: 注8:请参阅ISO/TR 21954，了解为特定患者选择合适呼吸机的指导。 ¾ISO 80601‑2‑13中规定的用于麻醉应用的呼吸机或附件； ¾ISO 80601-2-84中规定的用于紧急医疗服务环境的呼吸机或配件； ¾ISO 80601‑2-72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配件； ¾ISO 80601-2-79和ISO 80601-1-80中规定的用于家庭护理通气支持设备的呼吸机或附件； ¾阻塞性睡眠a

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment: ¾     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 2      For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 3      For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 4      A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. ¾     intended to be operated by a healthcare professional operator; and ¾     intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator 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 a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. NOTE 5     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 6     Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation. NOTE 7     A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining. 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: NOTE 8     See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾     ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13; ¾     ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84; ¾     ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72; ¾     ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80; ¾     obstructive sleep a