本文件适用于EMS呼吸机及其附件（以下也称为医用电气设备）的基本安全和基本性能: –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； –拟由医疗专业操作员操作； –用于EMS环境；和 –用于有创或无创通气。 注1:EMS呼吸机也可用于专业医疗机构内的运输。 *EMS呼吸机不考虑使用生理闭环控制系统，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呼吸机呼吸系统或EMS呼吸机的附件，这些附件的特性可能会影响EMS呼吸机的基本安全或基本性能。 注2: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规定。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- 1:2005，7.2.13和8.4.1。 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中给出的用于危重护理应用中依赖呼吸机的患者的呼吸机或附件。 –适用于家庭医疗环境中依赖呼吸机的患者的呼吸机或配件，见ISO 80601-2-72[3]。 –ISO 80601-2-13[4]中给出的用于麻醉应用的呼吸机或附件。 –用于呼吸机支持设备的呼吸机或附件（仅用于增强自主呼吸患者的通气），见ISO 80601- 2-79[5]和ISO 80601-2-80[6]1。 –ISO 80601-2-70[7]中给出的阻塞性睡眠呼吸暂停治疗医用电气设备。 –ISO 10651-4[8]中给出了操作员驱动的复苏器。 –ISO 10651-5[9]中给出的气体驱动紧急复苏器。 –持续气道正压通气（CPAP）医用电气设备。 –高频喷射通风机（HFJV），符合ISO 80601-2-87[11]的规定。 –高频振荡呼吸机（HFOV）[10]，符合ISO 80601-2-87[11]的规定。 –注4:EMS呼吸机可采用高频喷射或高频振荡通风模式。 -胸甲或“铁肺”呼吸机。

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: ¾     intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; ¾     intended to be operated by a healthcare professional operator; ¾     intended for use in the EMS environment; and ¾     intended for invasive or non-invasive ventilation. NOTE 2     An EMS ventilator can also be used for transport within a professional healthcare facility. An EMS 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 the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator. NOTE 3     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 4     Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for the following: NOTE 5     See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.  ¾     ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12. 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 anaesthetic applications, which are given in ISO 80601‑2‑13. ¾     ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80. ¾     obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70. ¾     user-powered resuscitators, which are given in ISO 10651‐4. ¾     gas-powered emergency resuscitators, which are given in ISO 10651‐5. ¾     continuous positive airway pressure (CPAP) ME equipment. ¾     high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87. ¾     high‐frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87. NOTE 6      An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes. ¾     respiratory high-flow therapy equipment, which are given in ISO 80601-2-90. NOTE 7      An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. ¾     oxygen therapy constant flow ME equipment. ¾     cuirass or “iron‐lung” ventilators.