ISO 5361:2023

This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications.

Tracheobronchial (including endobronchial) tubes (see ISO16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.

Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.

NOTE1 There is guidance or rationale for this clause contained in AnnexA.2.

NOTE2 ISO11990-1, ISO11990-2, and ISO14408 deal with laser surgery of the airway.