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ISO 9919

2nd Edition, March 15, 2005

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



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Superseded By: ISO 80601-2-61

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ENGLISH * W/D S/S BY ISO 80601-2-61
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Referenced Items:

IEC 60068-2-27
IEC 60068-2-32
IEC 60068-2-6
IEC 60068-2-64

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Description / Abstract:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.

NOTE See also 4.2.

This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.

In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series

2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1

3). IEC 61010 (all parts), Safety requirements for electrical equipment for measurement, control, and laboratory use 3) ISO 14708-1, Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

This International Standard 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.

* This International Standard 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.

This International Standard is not applicable to pulse oximeter equipment solely intended for foetal use.

This International Standard is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.

The requirements of this International Standard 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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