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
Subclause 1.1 of The general standard is replaced by:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETEREQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessaryfor 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, PULSEOXIMETER 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 oxygenhaemoglobin saturation and pulse rate of PATIENTS in professional healthcare institutions as well as PATIENTSin the HOME HEALTHCARE ENVIRONMENT.This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended for use in laboratoryresearch 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 subclauseapplies 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 ofthis standard are not covered by specific requirements in this standard except in 201.11 and in 7.2.13 and8.4.1 of the general standard.NOTE See also 4.2 of the general standard.This standard can also be applied to PULSE OXIMETER EQUIPMENT and their ACCESSORIES used forcompensation or alleviation of disease, injury or disability.This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use.This International Standard is not applicable to remote or slave (secondary) devices that display SpO2 valuesthat are located outside of the PATIENT ENVIRONMENT.
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