GB 9706.290-2022 Active

This document specifies the basic safety and basic performance of high-flow respiratory therapy devices (as defined in 201.3.220) used in combination with accessories (hereinafter referred to as ME devices or ME systems).
High-flow respiratory therapy devices:
—— Intended for patients who can breathe on their own; and
—— Intended for patients who need to improve alveolar gas exchange and can benefit from receiving high-flow humidified respiratory gas, including those with bypassed upper airways.
Example 1: Patients with Type 1 respiratory failure who show reduced arterial oxygenation.
Example 2: Patients with high arterial carbon dioxide levels who need to reduce respiratory effort according to the requirements of Type 2 respiratory failure.
Example 3: Patients who need humidification to improve mucociliary clearance.
High-flow respiratory therapy devices can be used in home care environments or professional medical institutions.
Note 1: When used in home care environments, the power supply network is often unreliable.
High-flow respiratory therapy devices can be:
—— Fully integrated ME devices; or
—— An ME system formed by combining separate products.
This document also applies to other types of respiratory devices that include high-flow respiratory therapy modes.