医用电气设备.第2-69部分:基本安全和基本性能的特殊要求 氧气浓缩器设备（ISO 80601-2-69-2020）

[中文适用范围]： 本文件规定了氧气浓缩器（及其配件，以下简称医用电气设备）的基本安全和基本性能要求，该设备旨在提高输送给单个患者的气体的氧气浓度。此类氧气浓缩器通常设计用于家庭医疗环境中的单个患者，在各种环境中使用，包括任何私人及公共交通工具以及商业飞机。此类氧气浓缩器也可用于专业医疗设施。本文件适用于可运输操作和不可运输操作的氧气浓缩器。本文件适用于集成在其他医疗设备、医用电气设备或医用系统中使用的氧气浓缩器，或与其一起使用的氧气浓缩器。本文件也适用于制造商意图连接到氧气浓缩器的配件，其中这些配件的特性可能影响氧气浓缩器的基本安全或基本性能。本文件不适用于与医用气体管道系统一起使用的氧气浓缩器的要求。 [外文原描述]： ISO 80601-2-69:2026 This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems. EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function. EXAMPLE 2 An oxygen concentrator used with a flowmeter stand. EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2]. EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function. This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator. NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment. This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system. 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 3 See also 4.2 of the general standard.