ISO 80601-2-70:2020 医用电气设备 第2-70部分：睡眠呼吸暂停呼吸治疗设备的基本安全和基本性能的特殊要求

标准编号：ISO 80601-2-70:2020

中文名称：医用电气设备 第2-70部分：睡眠呼吸暂停呼吸治疗设备的基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment — Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

发布日期：2020-11

标准范围

本文件适用于睡眠呼吸暂停呼吸治疗设备（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有阻塞性睡眠呼吸暂停的患者的呼吸道输送治疗性呼吸压力来缓解患者的症状。睡眠呼吸暂停呼吸治疗设备旨在由非专业操作者在家庭医疗保健环境中以及在专业医疗保健机构中使用。*睡眠呼吸暂停呼吸治疗设备不被视为利用生理闭环控制系统，除非其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呼吸治疗设备。本文件适用于为不依赖机械通气的患者设计的ME设备或ME系统。本文件不适用于为依赖机械通气的患者（如中枢性睡眠呼吸暂停患者）设计的ME设备或ME系统。本文件也适用于制造商打算连接到睡眠呼吸暂停呼吸治疗设备的附件，其中这些附件的特性会影响睡眠呼吸暂停呼吸治疗设备的基本安全性或基本性能。在睡眠呼吸暂停呼吸治疗期间使用的面罩和应用附件由ISO 17510另外解决。本文件进一步涵盖的项目见图AA.1。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，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。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，除通用标准的7.2.13和8.4.1外，本文件的具体要求未涵盖。注另见通用标准4.2。本文件不适用于ISO 80601-2-87[13]中给出的高频喷射通风机（HFJV）或高频振荡通风机（HFOV）。本文件未详细说明ISO 80601中给出的呼吸机或用于呼吸机依赖患者的重症监护呼吸机附件的要求？2？12.本文件未规定用于麻醉应用的呼吸机或附件的要求，这些要求在ISO 80601-2-13[8].本文件未规定用于呼吸机依赖患者的家庭护理呼吸机的呼吸机或附件的要求，这些要求在ISO 80601-2-72[9]中给出。本文件没有规定应急和运输用呼吸机或附件的要求，这些要求在ISO 80601-2-84[12]中给出。本文件没有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].

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].

标准预览图