The ISO 80601-2-61 standard, developed by the International Standards Organization (ISO), describes the basic safety and performance characteristics and test methods of pulse oximetry equipment. The pulse oximeter device is a device that quickly and easily measures oxygen saturation and pulse in the blood and also records the results. It is used in health institutions and hospitals, especially in anesthesia and intensive care units. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 80601-2-61 Electrical medical equipment - Part 2-61: Certain features for the required performance and basic safety of the pulse oximeter equipment.
This standard applies to the basic safety and basic performance of the pulse oximetry device intended for human use. This standard covers parts required for normal use including the pulse oximeter monitor, pulse oximeter probe and probe cable extender. These requirements also apply to pulse oximetry equipment, including reworked pulse oximetry monitors, pulse oximetry probes, and probe cable extensions.
Pulse oximetry is mainly used in professional healthcare facilities, hospitals, homes and emergency health care units to determine patients' arterial oxygen hemoglobin saturation and pulse rate. However, this standard does not include pulse oximetry equipment intended for use in laboratory research applications or oximeters that require a blood sample from a patient.
Hazards inherent in the intended physiological function of equipment or medical systems covered by this standard are also not covered by the specific requirements of this standard.
Meanwhile, this standard also applies to equipment and accessories used to compensate or alleviate illness, injury or disability.
Our organization also provides basic safety and performance testing services for ISO 80601-2-61 pulse oximeter equipment to businesses as part of our laboratory services .
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