Standards Development

Scope

This document defines terms for fields of respiratory care involving artificial ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation.

This document is applicable:

—     in lung ventilator and breathing-therapy equipment 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 information,

—     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 ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator and 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.

This document does not specify terms specific to high-frequency ventilation or jet ventilation, which are defined in ISO 19223-2:2025, terms specific to breathing-therapy equipment, which are defined in ISO 19223-3:2025, or to physiologic closed-loop ventilation, negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.

This document is structured based on the guidance and requirements specified in ISO 704:2022 and ISO 10241-1:2011.