ISO 80601-2-67:2020 医用电气设备 第2-67部分：保氧设备的基本安全和基本性能的特殊要求

标准编号：ISO 80601-2-67:2020

中文名称：医用电气设备 第2-67部分：保氧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 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

发布日期：2020-10

标准范围

本文件适用于在家庭医疗保健环境中使用时，氧气保存设备（以下简称ME设备）及其附件的基本安全性和基本性能，这些设备旨在通过间歇性输送气体并与患者的吸气周期同步来保存补充氧气。氧气保存设备通常由非专业操作员使用。注1保存设备也可用于专业保健机构。本文件也适用于保存与其他设备合并的设备。与压力调节器[2]、氧气浓缩器[7]或液氧设备[4]相结合的保存设备示例。本文件也适用于制造商打算连接到保存设备的附件，这些附件的特性会影响保存设备的基本安全或基本性能。本文件旨在通过要求标准化的性能测试和标签来澄清各种保存设备型号的操作差异，以及保存设备和连续流氧气设备的操作之间的差异。本文件仅适用于有源器械（如气动或电动），不适用于无源器械（如储液套管）。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。除IEC 60601-1:20 05+AMD1:2012、7.2.13和8.4.1。注2其他信息见IEC 60601-1:20 05+AMD1:2012,4.2。

This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.
NOTE 1 Conserving equipment can also be used in professional health care facilities.
This document is also applicable to conserving equipment that is incorporated with other equipment.
EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4].
This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.
This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.
This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).
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 IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

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