Code of Federal Regulations Title 21. Food and Drugs § 21.868.5273 Positive airway pressure delivery system

(i) Waveform testing must simulate breathing conditions and evaluate pressure and airflow response over a range and combination of high and low breath rates and tidal volumes.

(ii) Use life testing must demonstrate adequate device performance over the labeled use life of the device.

(iii) Device integrity testing must demonstrate that the device can withstand typical forces expected during use.

(iv) Carbon dioxide rebreathing testing must be performed.

(v) System flow rate, maximum expiratory pressure, inhalation pressure, and intra-mask static pressure testing must be performed.

(vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures.

(vii) Maximum limited pressure testing of the flow generator in single fault condition must be performed.

(viii) Maximum output temperature testing of delivered gas, if humidified, must be performed.

(i) Therapy pressure range;

(ii) Use life and replacement schedule for all components;

(iii) Cleaning instructions;  and

(iv) Instructions for assembly and connection of device components.