This document was approved and published when the U.S. TAG for TC 121 was held by ASTM, but it is now an AAMI standard. The original formatting has been maintained, so there are some variations from the typical AAMI style.

This part of ISO 5366 specifies requirements for tracheostomy tubes made of plastics materials and/or rubber having inside diameters of or greater. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support, but need not be restricted to these uses.

This part of ISO 5366 is not applicable to specialized tubes, and does not address flammability of tracheostomy tubes.