EN ISO 9919:2009

Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)

Publication date:   Aug 20, 2010

Scope

For the purposes of ISO 9919:2005, the Scope given in IEC 60601-1:1988 (Clause 1) applies, except as follows.
Amendment (add at the end of 1.1):
ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, that has 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 on patients in healthcare institutions as well as on patients in home care.
ISO 9919:2005 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that requires a blood sample from the patient.
ISO 9919:2005 is not applicable to pulse oximeter equipment solely intended for fetal use.
ISO 9919:2005 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.
The requirements of ISO 9919:2005 which replace or modify requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

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