ISO 80601-2-69:2020 医用电气设备 第2-69部分：氧浓缩器设备的基本安全和基本性能专用要求

标准编号：ISO 80601-2-69:2020

中文名称：医用电气设备 第2-69部分：氧浓缩器设备的基本安全和基本性能专用要求

英文名称：Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

发布日期：2020-11

标准范围

本文件规定了氧气浓缩机及其附件（以下称为ME设备）的基本安全和基本性能要求，旨在增加输送给单个患者的气体的氧气浓度。这种氧气浓缩器通常旨在由单个患者在各种环境中使用在家庭保健环境中，包括任何私人和公共交通工具以及商用飞机中。注1此类氧气浓缩机也可用于专业医疗机构。本文件适用于可运输和不可运输的氧气浓缩机。本文件适用于集成到其他医疗器械、ME设备或ME系统中或与其他医疗器械、ME设备或ME系统一起使用的氧气浓缩机。实施例1具有集成的氧气保存设备功能或加湿器功能的氧气浓缩器。实施例2与流量计支架一起使用的氧气浓缩器。实施例3氧气浓缩器作为麻醉系统的一部分，用于电力和麻醉气体物流供应有限的地区[2]。实施例4具有集成的储液器功能或气瓶填充系统功能的氧气浓缩器。本文件也适用于制造商打算连接到氧气浓缩机的附件，其中这些附件的特性会影响氧气浓缩机的基本安全或基本性能。注2此类附件可包括但不限于面罩、插管、延长管、加湿器、推车、手提箱、外部电源和氧气保存设备。本文件没有规定与医用气体管道系统一起使用的氧气浓缩机的要求。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3另见通用标准4.2。

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in various environments including any private and public transportation as well as in commercial aircraft.
NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities.
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.

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