standard byInternational Organization for Standardization , 04/01/2026
This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.262, hereafter also referred to as ME equipment or ME system, in combination with its accessories:
u000bu000bintended for use withpatients who can breathe spontaneously; andu000bintended forpatients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. u000bu000bEXAMPLE1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.
u000bEXAMPLE2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
u000bEXAMPLE3 Patients requiring humidification to improve mucociliary clearance.
u000bRespiratory high-flow therapy equipment is utilized in both professional healthcare facilities and the home healthcare environment. This standard specifically addresses respiratory high-flow therapy equipment for acute or infant care, predominantly found in hospitals. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming.
u000bRespiratory high-flow therapy equipment can be:
u000bu000bfully integratedME equipment; oru000ba combination of separate items forming aME system. u000bu000bThis document also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.
u000bNOTE2 This document and ISO80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode.
u000bNOTE3 This document and ISO80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode.
u000bNOTE4 This document and ISO80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode.
u000bRespiratory high-flow therapy equipment can be transit-operable.
u000bThis document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.
u000bEXAMPLE4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway.
u000bNOTE5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment.
u000bIf a clause or subclause is specifically intended to be applicable to MEequipment only, or to MEsystems 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 MEequipment and to MEsystems, as relevant.
u000bHazards inherent in the intended physiological function of MEequipment or MEsystems within the scope of this document are not covered by specific requirements in this document except in the general standard, 7.2.13 and 8.4.1.
u000bNOTE6 Additional information can be found in the general standard, 4.2.
u000bThis document does not specify the requirements for:
u000bu000bventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO80601 2 12;u000bventilators or accessories intended for anaesthetic applications, which are given in ISO80601 2 13;u000bventilators or accessories intended for the emergency medical services environment, which are given in ISO80601 2 84;u000bventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO80601 2 72;u000bventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO80601 2 79;u000bventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO80601 2 80;u000bsleep apnoea therapyMEequipment, which are given in ISO80601 2 70;u000bcontinuous positiveairway pressure (CPAP) MEequipment;u000bhigh-frequency jetventilators (HFJVs) [31], which are given in ISO80601 2 87;u000bgas mixers for medical use, which are given in ISO 11195;u000bflowmeters, which are given in ISO 15002;u000bhigh-frequency oscillatoryventilators (HFOVs), which are given in ISO80601 2 87; andu000bcuirass or “iron-lung” ventilation equipment.u000bu000bThis document is a particular standard in the IEC60601 series, the IEC80601 series and the ISO80601 series.
