医用电气设备第2-67部分:氧气保存设备的基本安全和基本性能的特殊要求

[中文适用范围]： 本文件适用于家庭医疗保健环境中使用的、旨在通过间歇性输送与患者吸气周期同步的气体来节约补充氧气的氧节约设备（以下简称医疗设备）的基本安全和基本性能。氧节约设备通常由非专业人员操作。注 1：节约设备也可用于专业医疗保健设施。本文件也适用于与其他设备结合的节约设备。示例：与压力调节器、氧气浓缩器或液氧设备结合的节约设备。本文件也适用于制造商意图连接到节约设备的配件，其中这些配件的特性可能影响节约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，澄清各种节约设备型号之间的操作差异，以及节约设备与连续流氧气设备之间的操作差异。本文件仅适用于有源设备（例如气动或电动供电），不适用于无源设备（例如储氧面罩）。如果某个条款或子条款专门适用于医疗设备或医疗系统，则该条款或子标题和内容将说明这一点。如果不是这种情况，则该条款或子条款适用于相关的医疗设备和医疗系统。 [外文原描述]： ISO 80601-2-67:2026 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[4], an oxygen concentrator[12] or liquid oxygen equipment[7]. 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+AMD2:2020, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.