ISO 80601-2-55:2018 医用电气设备 第2-55部分：呼吸气体监测器的基本安全和基本性能专用要求

标准编号：ISO 80601-2-55:2018

中文名称：医用电气设备 第2-55部分：呼吸气体监测器的基本安全和基本性能专用要求

英文名称：Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

发布日期：2018-02

标准范围

ISO 80601-2-55:2018规定了呼吸气体监测仪（rgm）的基本安全和基本性能的特殊要求，以下简称医用电气设备，用于患者的连续操作。ISO 80601-2-55:2018规定了-麻醉气体监测，-二氧化碳监测，以及-氧气监测。注1:rgm可以是独立的医用电气设备，也可以集成到其他设备中，例如麻醉工作站或呼吸机。ISO 80601-2-55:2018不适用于与易燃麻醉剂一起使用的rgm。如果某一条款或子条款明确规定仅适用于医用电气设备或医用电气系统，则该条款或子条款的标题和内容应如此说明。如果情况并非如此，则本条款或子条款适用于医用电气设备和医用电气系统（视情况而定）。除IEC 60601-1:2005+Amd 1:2012、7.2.13和8.4.1外，本文件中的具体要求未涵盖本文件范围内医用电气设备或医用电气系统预期生理功能的固有危险。注2:更多信息见IEC 60601-1:2005+Amd 1:2012, 4.2.

ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient.ISO 80601-2-55:2018 specifies requirements for- anaesthetic gas monitoring,- carbon dioxide monitoring, and- oxygen monitoring.NOTE 1 An rgm can be either stand-alone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.ISO 80601-2-55:2018 is not applicable to an rgm intended for use with flammable anaesthetic agents.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+Amd 1:2012, 7.2.13 and 8.4.1.NOTE 2 Additional information can be found in IEC 60601？1:2005+Amd 1:2012, 4.2.

标准预览图