BS EN ISO 80601-2-61-2011
医用电气设备.对脉搏血氧计设备基本安全和基本性能的特殊要求

Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeter equipment

标准号

BS EN ISO 80601-2-61-2011

发布日期

2011年08月31日

实施日期

2011年08月31日

废止日期

无

中国标准分类号

C38

国际标准分类号

11.040.55

发布单位

GB-BSI

引用标准

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

被代替标准

BS EN ISO 9919-2009

适用范围

Subclause 1.1 of The general standard is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE 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. This International Standard 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 standard are not covered by specific requirements in this standard except in 201.11 and in 7.2.13 and 8.4.1 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 for compensation 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 values that are located outside of the PATIENT ENVIRONMENT.

BS EN ISO 80601-2-61-2011系列标准

BS EN ISO 80601-2-61-2011 中可能用到的仪器设备