This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories:
— intended for use with patients who can breathe spontaneously; and
— intended for patients 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.
EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.
EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance.
Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities.
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
Respiratory high-flow therapy equipment can be:
— fully integrated ME equipment; or
— a combination of separate items forming a ME system.
This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.
NOTE 2 This standard and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode.
Respiratory high-flow therapy equipment can be transit-operable.
This 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.
EXAMPLE 4 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.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems 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 ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems 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.
NOTE 3 Additional information can be found in the general standard, 4.2.
This document does not specify the requirements for:
— ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
— ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
— ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
— ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
— ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79;
— ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601‑2‑80;
— sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
— continuous positive airway pressure (CPAP) ME equipment;
— high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87;
— gas mixers for medical use, which are given in ISO 11195;
— flowmeters, which are given in ISO 15002;
— high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87; and
— cuirass or “iron-lung” ventilation equipment.
This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.