本文件适用于睡眠呼吸暂停治疗设备（以下简称ME设备）的基本安全性和基本性能，该设备旨在通过向患者呼吸道输送治疗性呼吸压力来缓解阻塞性睡眠呼吸暂停患者的症状。睡眠呼吸暂停呼吸治疗设备适用于家庭医疗环境中的非专业操作人员以及专业医疗机构
*睡眠呼吸暂停呼吸治疗设备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治疗设置
本文件不包括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使用的医用电气设备或医用电气系统
本文件不适用于医用电气设备或医用电气系统，适用于依赖机械通气的患者，如中枢性睡眠呼吸暂停患者
本文件也适用于制造商拟连接至睡眠呼吸暂停呼吸治疗设备的附件，这些附件的特性可能会影响睡眠呼吸暂停呼吸治疗设备的基本安全或基本性能
ISO 17510还规定了睡眠呼吸暂停治疗期间使用的口罩和应用附件。参考图AA。1适用于本文件进一步涵盖的项目。
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说明。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）
除通用标准第7.2.13条和第8.4.1条外，本文件中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所固有的危险
注:另见通用标准的4.2
本文件不适用于ISO 80601-2-87[13]中给出的高频喷射式呼吸机（HFJV）或高频振荡式呼吸机（HFOV）
本文件未规定重症监护呼吸机或呼吸机附件的要求- ISO 80601？2？12中给出的依赖性患者
本文件未规定ISO 80601-2-13[8]中规定的麻醉用呼吸机或附件的要求
本文件未规定ISO 80601-2-72[9]中规定的呼吸机依赖患者家庭护理呼吸机的呼吸机或配件要求
本文件未规定ISO 80601-2-84[12]中规定的应急和运输用通风机或附件的要求
本文件未规定用于家庭护理通气支持的呼吸机或附件的要求，这些要求在ISO 80601-2-79[10]和ISO 80601-2-80[11]中给出。

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].