GB/T 46008-2025 Active

This document defines the terminology and semantic vocabulary used in all respiratory care fields involving mechanical ventilation, such as intensive care ventilation, anesthesia ventilation, emergency and transport ventilation, and home care ventilation (including sleep apnea treatment devices).
This document is applicable to:
—— Standards for lung ventilators and respiratory therapy devices;
—— Health informatics standards;
—— Labeling of medical electrical equipment and medical electrical systems;
—— Instructions for use and accompanying documents of medical electrical equipment and medical electrical systems;
—— Interoperability of medical electrical equipment and medical electrical systems; and
—— Electronic health records.
This document is also applicable to accessories manufactured by manufacturers for connection to ventilator respiratory systems or ventilators, where the characteristics of these accessories may affect the basic safety or basic performance of ventilators and ventilator respiratory systems.
Note: This document can also be used for other applications related to lung ventilation, including non-electrical equipment and devices, research, descriptions of critical events, forensic analysis, and adverse event (sentinel) reporting systems.
This document does not specify terminology for respiratory therapy devices or physiological closed-loop ventilation, high-frequency ventilation, or negative pressure ventilation; nor does it specify terminology for respiratory support using liquid ventilation or extracorporeal gas exchange or oxygen, except in cases where it is necessary to establish boundaries between critical concepts.