This International Standard specified particular requirement forthe basic safety and essential performance of pulse oximeterequipment intended for use on humans. This includes any partnecessary for normal use, e.g. the pulse oximeter monitor, pulseoximeter probe, probe cable extender.

These requirements also apply to pulse oximeter equipment,including pulse oximeter monitors, pulse oximeter probes and probecable extenders, that has been reprocessed.

The intended use of pulse oximeter equipment includes but is notlimited to, the estimation of arterial oxygen haemoglobinsaturation and pulse rate on patients in healthcare institutions aswell as on patients in home care.

* This International Standard is not applicable to pulse oximterequipment intended for use in laboratory research applications norto oximeters that requires a blood sample from the patient.

This International Standard is not applicable to remote or slave(secondary) devices that display SpO ₂ values that arelocated outside of the patient environment.

The requirements of this International Standard which replace ormodify requirements of IEC 60601-1:1988 and its Amendments 1 (1991)and 2 (1995) are intended to take precedence over the correspondinggeneral requirements.