YY/T 0338-2023 Active

This document specifies the requirements for tracheostomy tubes and connectors for adults and children.
This document applies to tracheostomy tubes primarily designed for patients requiring anesthesia, mechanical ventilation, or other respiratory assistance.
This document applies to specialized tracheostomy tubes with common characteristics, such as those without connectors at the machine end for patients breathing spontaneously, as well as tubes with reinforced walls or made of metal, tubes with shoulders, conical tubes, and tubes equipped for suction or monitoring or delivering drugs or other gases.
Note: The flammability of tracheostomy tubes (e.g., when using electrosurgical instruments or lasers with flammable anesthetics in oxygen-enriched air) is a well-known hazard that falls under clinical management and is not covered by this document. ISO/TR 11991 provides guidelines for preventing airway burns.