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Norm

ISO 9919:2005

Ausgabedatum: 2005 03 15

Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

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 p...
ZURÜCKGEZOGEN: 2011 03 16
Herausgeber:
International Organization for Standardization
Format:
Digital | 81 Seiten
Sprache:
Englisch

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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ISO 80601-2-61:2011
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ISO 9919:2005
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ISO 9919:1992
1992 07 23
Pulse oximeters for medical use — Requirements
Norm
Historie aufklappen
Norm
ISO 80601-2-61:2011
Ausgabedatum : 2011 03 16
Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment