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.
- not intended for patients who are dependent on artificial ventilation for their life support.
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
Ventilatory high-flow therapy equipment is typically composed of four parts:
1) gas sources,
- air, and
- if needed, oxygen;
NOTE 2 Gas sources include medical gas pipeline systems, gas cylinders, oxygen concentrators and ambient air.
NOTE 3 When dry gas is utilized, a humidifier is typically needed.
3) breathing tube;
4) a patient interface, which is used to deliver gas to the patient; and
5) a flow controller, which is used to select and deliver the desired flow.
NOTE 4 The flow controller can be at a fixed rate.
NOTE 5 The flowrate range is dependent upon the intended patient population (e.g., neonatal, paediatric and adult patients can require different flowrates).
These parts can be combined (e.g., the gas source and humidifier can be combined). Ventilatory highflow therapy equipment interfaces with the patient whose upper airway is intact via a nasal cannula or mask as well as a patient whose upper airway is bypassed via an endotracheal tube, oropharyngeal mask, or tracheostomy.
Ventilatory 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 ventilatory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory high-flow therapy equipment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
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 ventilatory impairment, which are given in ISO 80601 2 79;
- ventilatory support equipment or accessories intended for 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);
- high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601 2 87; and
- cuirass or "iron-lung" ventilation equipment.
NOTE 4 Ventilatory high-flow therapy equipment can be incorporated into any of the above equipment, in which case those standards would be applicable for those ventilation-modes.