標準號：BS EN ISO 80601-2-61-2011
中文標準名稱：醫用電氣設備.對脈搏血氧計設備基本安全和基本性能的特殊要求
英文標準名稱：Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeter equipment
標準類型：C38
發布日期：2011/8/31 12:00:00
實施日期：2011/8/31 12:00:00
中國標準分類號：C38
國際標準分類號：11.040.55
引用標準：IEC 60068-2-31-2008;IEC 60529-2001;IEC 60601-1-2-2007;IEC 60601-1-6-2010;IEC 60601-1-8-2006;IEC 60825-1-2007;ISO 7000/IEC 60417-2004;ISO 14155-2011;ISO 14937-2000;ISO 15223-1-2007;IEC 60068-2-27-2008;IEC 60068-2-64-2008;IEC 60601-1-9-2007;IEC 60601-1-10-2
適用范圍：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.