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 (ISO 80601-2-70:2025)

[中文适用范围]： 本文件适用于睡眠呼吸暂停治疗设备（以下简称ME设备）的基本安全和基本性能要求，该设备旨在通过向患者呼吸道输送治疗性呼吸压力，缓解患有阻塞性睡眠呼吸暂停患者的症状。睡眠呼吸暂停治疗设备可在家庭护理环境中由非专业操作者使用，也可在专业医疗机构中使用。除非该设备使用生理变量来调整治疗设置，否则不认为其使用了生理闭环控制系统。本文件不适用于用于新生儿的睡眠呼吸暂停治疗设备。本文件适用于那些不依赖人工通气的患者的ME设备或ME系统。本文件不适用于那些依赖人工通气的患者的ME设备或ME系统，例如患有中枢性睡眠呼吸暂停的患者。本文件也适用于由制造商设计用于连接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或基本性能。用于睡眠呼吸暂停治疗的面罩和应用附件还由ISO 17510另行处理。有关本文件涵盖的项目，请参见图AA.1。如果某条款或子条款仅特别适用于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明确指出这一点。如果未明确说明，则该条款或子条款适用于ME设备和ME系统，视情况而定。在本文件范围内，ME设备或ME系统固有的生理功能所带来的危险，除非在通用标准第7.2.13条和第8.4.1条中另有规定，否则本文件不提供具体要求。注意2：请参见通用标准第4.2条。本文件不规定以下设备或附件的要求： – 用于重症监护呼吸机依赖患者的呼吸机或相关附件，其规定见ISO 80601‑2‑12； – 用于麻醉应用的呼吸机或相关附件，其规定见ISO 80601-2-13； – 用于家庭护理呼吸机依赖患者的呼吸机或相关附件，其规定见ISO 80601-2-72； – 用于紧急和运输的呼吸机或相关附件，其规定见ISO 80601-2-84； – 用于家庭护理通气支持的呼吸机或相关附件，其规定见ISO 80601-2-79和ISO 80601-2-80； – 高频呼吸机[23]，其规定见ISO 80601-2-87； – 呼吸高流量设备，其规定见ISO 80601-2-90； 注意3：ISO 80601-2-80通气支持设备可以包含高流量治疗操作模式，但该模式仅适用于自主呼吸患者； – 用户驱动的复苏设备，其规定见ISO 10651-4； – 气体驱动的急救复苏设备，其规定见ISO 10651-5； – 氧疗恒流ME设备； – 以及胸腔或“铁肺”通气设备。 [外文原描述]： ISO 80601-2-70:2025 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 artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial 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 2 See also 4.2 of the general standard. 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. – ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13. – ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. – ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84. – ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80. – high-frequency ventilators[23], which are given in ISO 80601-2-87. – respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. – user-powered resuscitators, which are given in ISO 10651-4; – gas-powered emergency resuscitators, which are given in ISO 10651-5; – oxygen therapy constant flow ME equipment; and – cuirass or “iron-lung” ventilation equipment.