ISO 80601-2-84:2020 医疗电气设备 第2-84部分：紧急医疗服务环境中呼吸机的基本安全和基本性能的特殊要求

标准编号：ISO 80601-2-84:2020

中文名称：医疗电气设备 第2-84部分：紧急医疗服务环境中呼吸机的基本安全和基本性能的特殊要求

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：2020-07

标准范围

本文件适用于EMS呼吸机及其附件（以下也称为ME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；-拟由医疗保健专业人员操作；-预期用于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呼吸机不被认为使用生理闭环控制系统，除非其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呼吸机呼吸系统或EMS呼吸机的附件，其中这些附件的特性可能影响基本安全或基本安全。EMS呼吸机的性能。注2:如果某条款或子条款特别打算仅适用于ME设备，或仅适用于ME系统，则该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。除IEC 60601-1:20 05、7.2.13和8.4.1外，本文件中的具体要求未涵盖本文件范围内的医用电气设备或医用电气系统预期生理功能中固有的危害。注3其他信息见IEC 60601-1:20 05+AMD1:2012,4.2。本文件未规定以下要求:-用于危重护理应用中依赖呼吸机的患者的呼吸机或附件，在ISO 80601中给出-2-12.-用于家庭医疗环境中依赖呼吸机的患者的呼吸机或附件，其在ISO 80601-2-72[3]中给出。-用于麻醉应用的呼吸机或附件，其在ISO 80601-2-13[4]中给出。-用于通气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量），在ISO 80601中给出？2-79[5]和ISO 80601-2-80[6][1]。-阻塞性睡眠呼吸暂停治疗ME设备，其在ISO 80601-2-70[7]中给出。-操作员驱动的复苏器，其在ISO 10651-4[8]中给出。-气体动力紧急复苏器，在ISO 10651-5[9]中给出。-持续气道正压通气(CPAP)ME设备。-高频喷射通风机(HFJV)，在ISO 80601中给出-2-87[11].-高频振荡呼吸机(HFOV)[10]，其在ISO 80601-2-87[11]中给出。注4 EMS呼吸机可采用高频喷射或高频振荡通气模式。-胸甲或“铁肺”呼吸机。[1]ISO 80601-2-79和ISO 80601-2-80取代已撤销的ISO 10651-6。

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 1 An EMS ventilator can also be used for transport within a professional healthcare facility.
* An EMS ventilator is not considered to utilize 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 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 2 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, 7.2.13 and 8.4.1.
NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
This document does not specify the requirements for the following:
- ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72[3].
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‐2‐13[4].
- 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[5] and ISO 80601-2-80[6] [1].
- obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70[7].
- operator-powered resuscitators, which are given in ISO 10651‐4[8].
- gas-powered emergency resuscitators, which are given in ISO 10651‐5[9].
- continuous positive airway pressure (CPAP) ME equipment.
- high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87[11].
- high‐frequency oscillatory ventilators (HFOVs)[10], which are given in ISO 80601-2-87[11].
NOTE 4 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
- cuirass or "iron‐lung" ventilators.
[1] ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.

标准预览图