ISO 80601-2-85:2021 医用电气设备 第2-85部分：脑组织血氧计设备的基本安全性和基本性能的特殊要求

标准编号：ISO 80601-2-85:2021

中文名称：医用电气设备 第2-85部分：脑组织血氧计设备的基本安全性和基本性能的特殊要求

英文名称：Medical electrical equipment — Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment

发布日期：2021-03

标准范围

本文件适用于脑组织血氧仪设备的基本安全性和基本性能，该设备使用多个波长的光来定量测量在连接到头部的探头下采样的组织体积内的血红蛋白的氧饱和度。脑组织血氧计设备可以基于连续光、频域或时域技术。本文件适用于在医院环境中使用的ME设备以及在医院环境外使用的ME设备，如救护车和航空运输。附加标准可能适用于这些使用环境的ME设备。注1脑组织血氧仪在医学文献中有时被称为近红外光谱设备。不包括在本文件范围内的有:-侵入式组织或血管血氧计；-需要来自患者的血液样品的血氧计；-测量溶解氧的设备；-ME设备或其部分，其测量路径长度依赖性血红蛋白变化。对功能性近红外光谱设备的要求见ISO 80601-2-71[4]；-ME设备或其部分，其基于组织光学特性(SpO2)的脉动变化来测量动脉饱和度。对脉搏血氧仪设备的要求见ISO 80601？2？61[3];-ME设备或其任何部分，其声称监测除头部以外的身体部分中的组织。本文件也适用于再制造的脑组织血氧仪设备，包括脑组织血氧仪监护仪、脑组织血氧仪探头和探头电缆延长器。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相关的ME设备和ME系统。除通用标准201.11、201.7.2.13和201.8.4.1外，本文件中的具体要求未涵盖本文件范围内的医用电气设备或医用电气系统预期生理功能中固有的危害。注2另见通用标准4.2。本文件也可适用于用于补偿或减轻疾病、伤害或残疾的ME设备及其附件。本文件不适用于显示位于患者环境之外的StO2值的远程或从属（辅助）设备。注3:在诊断和监测功能之间提供选择的ME设备在配置该功能时应满足相应文档的要求。

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use.
NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical literature.
Not included within the scope of this document are:
- invasive tissue or vascular oximeters;
- oximeters that require a blood sample from the patient;
- equipment measuring dissolved oxygen;
- ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71[4];
- ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2). The requirements for pulse oximeter equipment are found in ISO 80601？2？61[3];
- ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the head.
This document also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders, that have been remanufactured.
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 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard.
NOTE 2 See also 4.2 of the general standard.
This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury or disability.
This document is not applicable to remote or slave (secondary) equipment that displays StO2 values that are located outside of the patient environment.
NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.

标准预览图