NS-EN ISO 80601-2-90:2021

This document applies to the basic safety and essential performance of ventilatory high-flow therapy equipment, as defined in 201.3.204, hereafter also referred to as ME equipment, in combination with its accessories: - intended for use in the home healthcare environment; - intended for use in professional healthcare facilities; - intended for use by a lay operator or a healthcare professional operator; - intended for use with patients who can breathe spontaneously; - intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, including a patient whose upper airway is bypassed; and EXAMPLE 1 Patients with Type 1 Respiratory Failure, which exhibits a reduction in arterial blood oxygenation or patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.