ISO 80601-2-61:2011 医用电气设备 第2-61部分：脉搏血氧仪的基本安全和基本性能专用要求

标准编号：ISO 80601-2-61:2011

中文名称：医用电气设备 第2-61部分：脉搏血氧仪的基本安全和基本性能专用要求

英文名称：Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

发布日期：2011-04

标准范围

ISO 80601-2-61:2011适用于人体脉搏血氧仪设备（以下简称医用电气设备）的基本安全和基本性能。这包括正常使用所需的任何部件，包括脉搏血氧计监测器、脉搏血氧计探头和探头电缆延长器。这些要求也适用于脉搏血氧仪设备，包括经过再处理的脉搏血氧仪监测器、脉搏血氧仪探头和探头电缆延长线。脉搏血氧仪设备的预期用途包括但不限于对专业医疗机构患者以及家庭医疗环境中患者的动脉血氧血红蛋白饱和度和脉搏率的估计。ISO 80601-2-61:2011不适用于实验室研究应用中使用的脉搏血氧仪设备，也不适用于需要患者血样的血氧仪。ISO 80601-2-61:2011也适用于用于补偿或减轻疾病、伤害或残疾的脉搏血氧仪设备及其附件。ISO 80601-2-61:2011不适用于专为胎儿使用的脉搏血氧仪设备。ISO 80601-2-61:2011不适用于远程或从属（辅助）设备，这些设备显示位于患者环境之外的SpO2值。

ISO 80601-2-61:2011 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.ISO 80601-2-61:2011 can also be applied to pulse oximeter equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended solely for foetal use.ISO 80601-2-61:2011 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.

标准预览图