DIN EN ISO 5361/A1:2025-08
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 / Note: Date of issue 2025-07-18*Intended as an amendment to DIN EN ISO 5361 (2024-11).
| Fecha edición: |
2025-08-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | 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. |
| Keywords: | Anaesthetic equipment|Breathing equipment|Cole|Connecting pieces|Disinfection|Magill|Marking|Materials|Medical products|Medical technology|Murphy|Performance requirements|Plastics|Rescue and ambulance services|Safety requirements|Specification (approval)|Sterilization (hygiene)|Testing|Tracheal tubes|Vulcanized rubber |
| ICS: | 11.040.10 - Equipo de respiración, anestesia y reanimación |
| CTN: |
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