This document defines terms for:

—     high-frequency oscillatory ventilation (HFOV);

—     percussive ventilation, including high-frequency percussive ventilation (HFPV);

—     jet ventilation, including high frequency jet ventilation (HFJV);

—     modes that combine high-frequency and physiological-rate ventilation.

It is applicable:

—     in lung ventilator and breathing-therapy device standards,

—     in health informatics standards,

—     for labelling on medical electrical equipment and medical electrical systems,

—     in medical electrical equipment and medical electrical system instructions for use and accompanying documents,

—     for medical electrical equipment and medical electrical systems interoperability, and

—     in electronic health records.

This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilatorbreathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator or ventilator breathing system.

NOTE            This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.