医疗电气设备 - 第2-26部分:脑电图基本安全和基本表现的特殊要求

[中文适用范围]： 80601 国际标准的这一部分适用于 201.3.204@ 中定义的脑电图的基本安全和基本性能，下文也称为 ME 设备或 ME 系统。本文件适用于用于专业医疗机构@紧急医疗服务环境或家庭医疗环境的脑电图。本文件不涵盖脑电图检查中使用的其他设备的要求，例如： ?C 声光刺激器； ?C 脑电图数据存储和检索； ?C ME 设备特别适用于电休克治疗期间的监测。如果某条款或子条款专门旨在仅适用于 ME 设备@或仅适用于 ME 系统@，则该条款或子条款的标题或内容将如此说明。如果情况并非如此@，则该条款或子条款同时适用于 ME 设备和 ME 系统@，如下所示。该条款或子条款默认适用于 ME EQUIPMENT@。对于具有相应安全措施或功能但未完全集成到 ME 设备中而是在 ME 系统中实施的 ME 设备，ME 设备制造商在随附文件中指定 ME 系统提供哪些功能和安全要求以符合本文件。 ME 系统经过相应验证。本文件的具体要求不涵盖本文件范围内 ME 设备或 ME 系统的预期生理功能所固有的危险。注：另见通用标准4.2。 [外文原描述]： IEC 80601-2-26:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: – phono-photic stimulators; – EEG data storage and retrieval; – ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or 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 follows. The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. 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. IEC 80601-2-26:2019 cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-1:2005, new versions of collateral standards and amendments thereto. The contents of the corrigendum of October 2021 have been included in this copy.