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Reference ISO 80601-2-61 ed1.0 withdrawn corrigendum
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Title Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Publication date 2011-03-16
Format, price
(Swiss francs)
and language
198.- 83 pages
198.- 1312 Kb
 
Abstract ISO 80601-2-61:2011 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. ISO 80601-2-61:2011 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. ISO 80601-2-61:2011 can also be applied to pulse oximeter equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2011 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.
Technical Committee 62D - Electromedical equipment  RSS
ICS Codes
11.040.10 Anaesthetic, respiratory and reanimation equipment
*Including medical gas installations
 
Replaced by
Stability date 2014
 
Work in progress
ProjectStage codeForecast publication date
ISO 80601-2-61 Ed.1  BPUB2011-04-01


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