医疗电气设备 - 第2-67部分:氧气保存设备的基本安全和基本性能的特殊要求

[中文适用范围]： 本文件适用于睡眠呼吸暂停治疗设备的基本安全性和基本性能，以下简称ME设备，旨在通过向患者呼吸道提供治疗性呼吸压力来缓解阻塞性睡眠呼吸暂停患者的症状。睡眠呼吸暂停治疗设备适用于家庭医疗环境中的非专业操作者以及专业医疗机构使用。 * 睡眠呼吸暂停治疗设备不被视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治疗设置。 本文件排除了用于新生儿的睡眠呼吸暂停治疗设备。 本文件适用于不依赖机械通气的患者的ME设备或ME系统。 本文件不适用于依赖机械通气的患者的ME设备或ME系统，如中枢性睡眠呼吸暂停患者。 本文件也适用于制造商意图连接到睡眠呼吸暂停治疗设备的附件，这些附件的特性可能影响睡眠呼吸暂停治疗设备的基本安全性或基本性能。 用于睡眠呼吸暂停治疗期间的面罩和应用附件还由ISO 17510规定。请参阅图AA.1以了解本文件涵盖的项目。 如果条款或子条款专门适用于ME设备或ME系统，则该条款或子条款的标题和内容将说明。如果不是这种情况，则该条款或子条款适用于ME设备和ME系统。 本文件范围内的ME设备或ME系统的预期生理功能固有的危险不在本文件的特定要求范围内，除了通用标准的7.2.13和8.4.1。 本文件不适用于高频喷射呼吸机（HFJV）或高频振荡呼吸机（HFOV），这些由ISO 80601-2-87[13]规定。 本文件不规定用于依赖通气患者的危重症呼吸机或附件的要求，这些由ISO 80601-2-12规定。 本文件不规定用于麻醉应用的呼吸机或附件的要求，这些由ISO 80601-2-13[8]规定。 本文件不规定用于依赖通气患者的家庭护理呼吸机或附件的要求，这些由ISO 80601-2-72[9]规定。 本文件不规定用于急救和运输的呼吸机或附件的要求，这些由ISO 80601-2-84[12]规定。 本文件不规定用于家庭护理通气支持的呼吸机或附件的要求，这些由ISO 80601-2-79[10]和ISO 80601-2-80[11]规定。 [外文原描述]： This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. * Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. 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 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[13]. This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12. This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[8]. This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72[9]. This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84[12]. This document does not specify the requirements for ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79[10] and ISO 80601‑2‑80[11].