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Publication details

Publication CODE Title
ISO 80601-2-61:2011 (2011-03) MEDICAL ELECTRICAL EQUIPMENT -- PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
 
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Description
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.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
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FR version

Status
Status IEC PUBLICATION
Situation Withdrawn
Replaced by  ISO 80601-2-61:2017
Replaces  ISO 9919:2005
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2011-03-16
ICS-Code (International Standards Classification) 11.040.10
NBN Status New
IEC publication date 2011-03-16
IEC stability date 2018-12-31
IEC last modification date 2018-06-27