标准编号：ISO 80601-2-84:2023
中文名称：医用电气设备 第2-84部分：紧急医疗服务环境用呼吸机的基本安全和基本性能专用要求
英文名称：Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
发布日期：2023-11
标准范围
Replacement: NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2. 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: ？ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; ？ intended to be operated by a healthcare professional operator; ？ intended for use in the EMS environment; and ？ 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. ？ ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
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