IEC 80601-2-71:2025 医用电气设备.第2-71部分:功能近红外光谱（NIRS）设备的基本安全和基本性能的特殊要求

标准编号：IEC 80601-2-71:2025

中文名称：医用电气设备.第2-71部分:功能近红外光谱（NIRS）设备的基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

发布日期：2025-01-14

标准范围

IEC 80601-2-71:2025适用于201.3.205中定义的功能性NIRS设备的基本安全和基本性能，这些设备旨在单独使用，或作为ME系统的一部分，以下称为ME设备。除IEC 60601-1:20 05、IEC 60601-1:20 05/AMD1:2012和IEC 60601-1:20 05/AMD2:2020、7.2.13和8.4.1之外，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。本文件不适用于-用于测量微血管(毛细血管、小动脉和小静脉)中血红蛋白的氧饱和度的设备，即组织血氧计；-用于功能性近红外光谱的频域和时域设备；-用于测量除氧基以外的发色团浓度变化的设备-和脱氧血红蛋白；-用于测量除脑以外的组织中氧和脱氧血红蛋白浓度变化的设备。本文件未规定以下方面的要求:-脑组织血氧计设备，其在ISO 80601-2-85中给出；和-脉搏血氧仪设备，其在ISO 80601-2-61中给出。IEC 80601-2-71:2025取消并取代2015年发布的第一版。本版构成技术修订版。与上一版相比，此版本包括以下重大技术变更:a)与IEC 60601-1:20 05、IEC 60601-1:20 05/AMD1:2012、IEC 60601-1:20 05/AMD2:2020、IEC 60601-1-8:20 06/AMD1:2012、IEC 60601-1-8:20 06/AMD2:2020、IEC 60601-1-2:20 14、IEC 60601-1-2:20 14/AMD1:2020、IEC 60601-1-2:20 14、IEC 60601-1-2:20 14、IEC 60601-1-6:20 10、IEC 60601-1-6:20 0/AMD1:2013和IEC 60601-1-6:20 0/AMD2:2020；b)增加了基本性能的要求；c)增加了对主要操作功能的要求；d)增加了防止温度过高的要求；e)增加了对佩戴个人防护设备的操作员的显示易读性的要求；f)在适当情况下与ISO 20417协调。

IEC 80601-2-71:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT, as defined in 201.3.205, intended to be used by itself, or as a part of an ME SYSTEM hereinafter referred to as ME EQUIPMENT.
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, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1.
This document is not applicable to
– equipment for the measurement of oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules), i.e. tissue oximeters;
– frequency-domain and time-domain equipment for functional near-infrared spectroscopy;
– equipment for the measurement of changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin;
– equipment for the measurement of changes in the concentration of oxy- and deoxy-haemoglobin in tissues other than the brain.
This document does not specify the requirements for:
– cerebral tissue oximeter equipment, which are given in ISO 80601-2-85; and
– pulse oximeter equipment, which are given in ISO 80601-2-61.
IEC 80601-2-71:2025 cancels and replaces the first edition published in 2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020;
b) added requirements for ESSENTIAL PERFORMANCE;
c) added requirements for PRIMARY OPERATING FUNCTIONS;
d) added requirements for protection against excessive temperatures;
e) added requirements for the display legibility for OPERATORS wearing personal protective equipment;
f) harmonization with ISO 20417, where appropriate.

标准预览图