医用电气设备.医用脉动式血氧计的基本安全和性能的特殊要求

[中文适用范围]： IEC 60601-1:1988 第 1 条适用，但以下情况除外。 修正案（在1.1末尾添加）：本国际标准规定了供人体使用的脉搏血氧计设备的基本安全和基本性能的特殊要求。 这包括正常使用所需的任何部件，例如脉搏血氧计监测仪、脉搏血氧计探头、探头电缆延长器。 这些要求也适用于经过再处理的脉搏血氧计设备，包括脉搏血氧计监护仪、脉搏血氧计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医疗机构患者以及家庭护理患者的动脉氧血红蛋白饱和度和脉搏率。 * 本国际标准不适用于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。 本国际标准不适用于仅供胎儿使用的脉搏血氧计设备。 本国际标准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。 本国际标准的要求取代或修改了 IEC 60601-1:1988 及其修正案 1 (1991) 和 2 (1995) 的要求，旨在优先于相应的一般要求。 [外文原描述]： For the purposes of ISO 9919:2005, the Scope given in IEC 60601-1:1988 (Clause 1) applies, except as follows. Amendment (add at the end of 1.1): ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, that has 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 on patients in healthcare institutions as well as on patients in home care. ISO 9919:2005 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that requires a blood sample from the patient. ISO 9919:2005 is not applicable to pulse oximeter equipment solely intended for fetal use. ISO 9919:2005 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment. The requirements of ISO 9919:2005 which replace or modify requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.