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

ISO 80601-2-61 applies to the essential safety and essential performance of pulse oximetry equipment intended for human use, hereinafter referred to as I equipment. This includes all parts necessary for normal use, including the pulse oximetry monitor, pulse oximetry probe, and probe cable extender. These requirements also apply to pulse oximetry equipment, including reworked pulse oximetry monitors, pulse oximetry probes, and probe cable extenders.

Intended uses of pulse oximetry equipment include, but are not limited to, estimation of arterial oxygen hemoglobin saturation and pulse rate of patients in professional healthcare settings, as well as patients in home healthcare settings and emergency medical services settings.

ISO 80601-2-61 does not apply to pulse oximetry equipment intended for use in laboratory research applications or oximeters that require a blood sample from the patient.

ISO 80601-2-61 is also applicable to equipment and accessories used to compensate or alleviate illness, injury or disability.

ISO 80601-2-61 is applicable to pulse oximetry equipment intended for use in extreme or uncontrolled environmental conditions outside the hospital environment or doctor's office, such as ambulances and air transport. Additional standards may apply pulse oximetry equipment for these use environments.

EUROLAB assists manufacturers with ISO 80601-2-61 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.