IEC 80601-2-26:2019 医疗电气设备 - 第2-26部分:脑电图基本安全和基本性能的特殊要求

标准编号：IEC 80601-2-26:2019

中文名称：医疗电气设备 - 第2-26部分:脑电图基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph

发布日期：2019-05-20

标准范围

IEC 80601-2-26:2019适用于201.3.204中定义的脑电图仪的基本安全性和基本性能，以下也称为ME设备或ME系统。本文件适用于专业医疗机构、紧急医疗服务环境或家庭医疗环境中使用的脑电图仪。本文件不涵盖脑电图中使用的其他设备的要求，例如:-声-光刺激器；-EEG数据存储和检索；-特别用于电惊厥治疗期间监测的ME设备。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或内容将如此说明。如果不是这种情况，该条款或子条款适用于ME设备和ME系统，如下所示。默认情况下，该条款或子条款适用于ME设备。对于相应安全措施或功能未完全集成到ME设备中而是在ME系统中实现的ME设备，ME设备制造商应在随附文件中规定ME系统提供哪些功能和安全要求以符合本文件。对ME系统进行了相应的验证。本文件范围内的ME设备或ME系统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。IEC 80601-2-26:2019取消并取代2012年发布的IEC 60601-2-26第三版。本版本构成技术修订，以符合IEC 60601-1:20 05的修订1:20 12、抵押品标准的新版本及其修订。

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.

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