ISO 80601-2-61 Special Requirements for Basic Safety and Basic Performance of Pulse Oximetry Equipment

Medical Device Tests

ISO 80601-2-61 Special Requirements for Basic Safety and Basic Performance of Pulse Oximetry Equipment

This International Standard applies to the essential safety and essential performance of pulse oximetry equipment intended for human use, hereinafter referred to as ME equipment. This is pulse oximetry tracker, pulse oximetry probe
and includes all parts necessary for normal use, including the probe cable extender.

ISO 80601-2-61 Special Requirements for Basic Safety and Basic Performance of Pulse Oximetry Equipment

These requirements also apply to pulse oximetry equipment, including reworked pulse oximetry trackers, pulse oximetry probes, and probe cable extenders.

The intended use of the pulse oximeter device includes, but is not limited to, the estimation of arterial oxygen hemoglobin saturation and pulse rate in patients in professional healthcare institutions and home healthcare settings. This International standard does not apply to pulse oximetry equipment intended for use in laboratory research applications or oximeters that require patient blood sampling.

If an article or subclause is specifically intended to apply to ME equipment only or ME systems only, the title and content of that article or subclause shall indicate so. If this is not the case, the item or sub-substance is both ME equipment.
as well as relevantly for ME systems.

This standard is also applicable to pulse oximetry equipment and accessories used for the compensation or alleviation of disease, injury or disability. This International Standard does not apply to pulse oximetry equipment for fetal use only. This International Standard does not apply to remote or slave (secondary) devices that display SpO2 values ​​outside the patient environment.

Estimation of arterial hemoglobin saturation and pulse rate using pulse oximetry is a common practice in many fields of medicine. This standard provides basic safety and basic performance achievable within the limits of current technology.
covers the requirements.

Among the services provided by our organization within the framework of material testing services, there are also ISO 80601-2-61 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.

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