ISO 80601-2-61:2017适用于拟用于人体的脉搏血氧仪设备（以下简称me设备）的基本安全性和基本性能。这包括正常使用所需的任何部件，包括脉搏血氧仪监测器、脉搏血氧仪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，包括经过再加工的脉搏血氧仪监护仪、脉搏血氧仪探头和探头电缆延长器。 脉搏血氧仪设备的预期用途包括但不限于估计专业医疗机构中的患者以及家庭医疗环境和紧急医疗服务环境中的患者的动脉氧血红蛋白饱和度和脉搏率。 ISO 80601-2-61:2017不适用于预期用于实验室研究应用的脉搏血氧仪设备，也不适用于需要患者血样的血氧仪。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、7.2.13和8.4.1中的规定外，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不在本文件的具体要求范围内。 注1另见通用标准4.2。“通用标准”为IEC 60601-1:20 05+AMD1:2012，医用电气设备？第1部分:基本安全和基本性能的一般要求。 ISO 80601-2-61:2017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。ISO 80601-2-61:2017不适用于仅供胎儿使用的脉搏血氧仪设备。 ISO 80601-2-61:2017不适用于显示位于患者环境之外的SpO2值的远程或从属（辅助）设备。 注2: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。 ISO 80601-2-61:2017适用于在医院环境或医生办公室之外的极端或不受控制的环境条件下使用的脉搏血氧仪设备，如救护车和航空运输。附加标准可以将脉搏血氧仪设备应用于这些使用环境。 ISO 80601-2-61:2017是IEC 60601-1和ISO/IEC 80601系列标准中的特定标准。

ISO 80601-2-61:2017 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 and the emergency medical services environment. ISO 80601-2-61:2017 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. 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 7.2.13 and 8.4.1 of the general standard. NOTE 1 See also 4.2 of the general standard. "The general standard" is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment?Part 1: General requirements for basic safety and essential performance. ISO 80601-2-61:2017 can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2017 is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment. NOTE 2 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. ISO 80601-2-61:2017 is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use. ISO 80601-2-61:2017 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.