DIN Standards Committee Health Technologies
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023); German version EN ISO 5361:2023
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
2024-06-25
Planned document number
DIN EN ISO 5361
Project number
17600054
Responsible national committee
NA 176-05-05 AA - Airways and related equipment
Responsible european committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Responsible international committee
ISO/TC 121/SC 2 - Airway devices and related equipment
