医用电气设备第2-84部分:紧急医疗服务环境用通风机的基本安全和基本性能的特殊要求

[中文适用范围]： 本文件适用于急救医疗服务（EMS）环境下的呼吸机及其配件的基本安全和基本性能。该设备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；由医疗保健专业人员操作；适用于急救医疗服务环境；适用于有创或无创通气。本文件也适用于制造商意图连接到呼吸机呼吸系统或EMS呼吸机，且其特性可能影响EMS呼吸机基本安全或基本性能的配件。本文件不适用于：重症监护应用中的呼吸机或配件（ISO 80601-2-12）；家庭医疗环境中的呼吸机或配件（ISO 80601-2-72）；麻醉应用中的呼吸机或配件（ISO 80601-2-13）；仅用于增强自主呼吸患者通气的通气支持设备（ISO 80601-2-79和ISO 80601-2-80）；阻塞性睡眠呼吸暂停治疗设备（ISO 80601-2-70）；操作者驱动的复苏器（ISO 10651-4）；气体驱动的紧急复苏器（ISO 10651-5）；持续气道正压通气（CPAP）设备；高频喷射呼吸机（HFJVs）；高频振荡呼吸机（HFOVs）；胸壁或“铁肺”呼吸机。 [外文原描述]： 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.