ISO 80601-2-13:2022 医用电气设备 第2-13部分：麻醉工作区的基本安全和基本性能专用要求

标准编号：ISO 80601-2-13:2022

中文名称：医用电气设备 第2-13部分：麻醉工作区的基本安全和基本性能专用要求

英文名称：Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

发布日期：2022-04

标准范围

ISO 80601-2-13:20 22本文件适用于在专业操作员持续参与下进行吸入麻醉的麻醉工作站的基本安全性和基本性能。本文件规定了完整麻醉工作站和以下麻醉工作站组件的特殊要求，尽管这些组件本身被视为独立设备，但可以与其他相关麻醉工作站组件结合使用，以形成符合给定规格的麻醉工作站:-麻醉气体输送系统；-麻醉呼吸系统；-麻醉气体清除系统(AGSS)；-麻醉蒸汽输送系统；-麻醉呼吸机；-监测设备；-报警系统；-保护装置。注1监控设备、报警系统及保护装置汇总于表AA.1。根据一般标准，完整供应的麻醉工作站及其单个组件被视为ME设备或ME系统。注2本文件的适用性见表AA.2。本文件也适用于制造商打算连接到麻醉工作站的附件，其中这些附件的特性会影响麻醉工作站的基本安全性和基本性能。如果一个条款或子条款特别旨在仅适用于麻醉工作站组件或其附件，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麻醉工作站及其相关的单个组件，包括附件。除IEC 60601-1:20 05+AMD1:2012+AMD2:2020、7.2.13和8.4.1中的规定外，本文件范围内的麻醉工作站及其单个组件（包括附件）预期生理功能中固有的危害不在本文件的具体要求范围内。注3另见IEC 60601-1:20 05+AMD1:2012+AMD2:2020,4.2。本文件不适用于附件BB确定的任何预期与易燃麻醉剂一起使用的麻醉工作站。

ISO 80601-2-13:2022 This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:
- anaesthetic gas delivery system;
- anaesthetic breathing system;
- anaesthetic gas scavenging system (AGSS);
- anaesthetic vapour delivery system;
- anaesthetic ventilator;
- monitoring equipment;
- alarm system;
- protection device.
NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.
An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard.
NOTE 2 The applicability of this document is indicated in Table AA.2.
This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.
If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories 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 an anaesthetic workstation and its individual components including accessories, as relevant.
Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories 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 3 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.

标准预览图