Abstract

This document provides the essential performance and safety requirements for tracheal tubes and tracheal tube connectors. Tracheal tubes are intended to be inserted orally or nasally through the larynx into the trachea to convey gases and vapours to and from a patient's lungs during spontaneous, assisted or controlled ventilation for short or prolonged durations. In addition, tracheal tubes with cuffs are intended to seal and protect the trachea from aspiration. A variety of cuff designs are available to meet particular clinical requirements. Cuff performance requirements with associated test methods remain unchanged from the second edition. Requirements for paediatric tracheal tubes, with and without cuffs, have been updated from the third edition to include new guidance on the design of tracheal tubes for used in paediatric and neonatal patients. The maximum distance from the patient end of the tracheal tube to the machine end of the inflatable length of the cuff has been revised in this edition to minimise the risk of the inflatable length of the cuff aligning with the larynx of neonatal and paediatric patients. Tracheal tubes are intended to conform as closely as possible to human anatomy when in position. Clinical considerations have also dictated the specified length of tracheal tubes because long tracheal tubes, sometimes of relatively narrow diameter, can be required and, therefore, should be readily available.

Begin

2025-06-11

WI

00215372

Planned document number

DIN EN ISO 5361/A1

Project number

17600165

Responsible national committee

NA 176-05-05 AA - Airways and related equipment  

Responsible european committee

CEN/TC 215/WG 4 - Airway devices, related equipment and suction devices  

Responsible international committee

ISO/TC 121/SC 2 - Airway devices and related equipment  

draft standard

Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1: Reinstatement of third edition S1 dimensions (ISO 5361:2023/DAM 1:2025); German and English version EN ISO 5361:2023/prA1:2025
2025-08
Order from DIN Media