ISO/AWI 80601-2-97

Medical electrical equipment — Part 2-97: Particular requirements for basic safety and essential performance of supportive home high-flow respiratory equipment

Scope

A home high flow therapy (HFT) device blows air at a controlled flowrate, humidifies and conducts the air through a heated tube. The heated tube connects to a respiratory high-flow nasal cannula.
Room air is drawn into the device by a blower such as a turbine.
Supplemental oxygen is commonly sourced from equipment for long term oxygen therapy such as a home cylinder or stationary oxygen concentrator.
Home HFT is predominantly used in home healthcare facilities. It is suitable for use in professional healthcare environment to assist patient setup and trial.
Home HFT is used by spontaneously breathing patients to relieve respiratory symptoms that interfere with daily living and to reduce the incidence of acute exacerbations requiring hospital care
The blower, humidifier and heated tube have integrated control. A single fault in one of these can be responded by deactivating the other two to reach a safe state of inactivity.
One category of home HFT is described for devices that incorporate alarms to alert a patient or carer to incorrect device operation. A second category is described for devices that serve patient groups at lower risk.