Overview
EN ISO 5361:2023 (ISO 5361:2023, corrected version 2023-11) specifies safety and essential performance requirements for tracheal tubes and tracheal tube connectors used in anaesthetic and respiratory care. It covers oro‑tracheal and naso‑tracheal tubes, reinforced tubes, tapered and shoulder tubes, and tracheal tubes with provisions for suctioning, monitoring or drug/gas delivery. The standard excludes tracheobronchial/endobronchial tubes (see ISO 16628), tracheostomy tubes (ISO 5366), supralaryngeal airways (ISO 11712), and devices intended for use with lasers, electrosurgery or flammable anaesthetic agents.
Key topics and technical requirements
EN ISO 5361:2023 addresses design, materials, testing and labelling to ensure device safety and performance. Main technical topics include:
- General safety and performance: basic requirements for intended use during spontaneous, assisted or controlled ventilation.
- Materials and biocompatibility: biological safety testing and reuse considerations.
- Design requirements and dimensions: size designation, tube curvature, surface finish and radiopaque markers.
- Cuffed tube specifics: cuff designs, cuff inflating systems and revised guidance on cuff position-including updates to the maximum distance from the patient end to the machine end of the inflatable cuff length (important for neonatal/pediatric safety).
- Connectors and compatibility: dimensional and marking requirements for tracheal tube connectors.
- Kink resistance and mechanical tests: methods and normative annexes for kink resistance, cuff collapse, cuff herniation and tracheal seal.
- Labelling and instructions: required markings, durability of markings and manufacturer information for safe clinical use.
- Annexes: informative rationale and design guidance (Annex A/B) plus normative test procedures (Annex C–H) and hazard identification (Annex G).
Practical applications and target users
This standard is essential for:
- Medical device manufacturers and designers developing or validating tracheal tubes and connectors.
- Quality assurance and regulatory teams ensuring conformity with ISO/CEN requirements for CE marking and market access in Europe.
- Test laboratories and notified bodies conducting performance and safety testing.
- Biomedical engineers, procurement specialists and hospital supply teams specifying compliant airway devices.
- Clinicians (anesthesiologists, intensivists, respiratory therapists) who rely on standardized device dimensions, cuff performance and labelling for safe airway management.
Related standards
- ISO 18190 - general standard for airway devices (alignment noted in this edition)
- ISO 16628 - tracheobronchial and endobronchial tubes (excluded)
- ISO 5366 - tracheostomy tubes (excluded)
- ISO 11712 - supralaryngeal airways (excluded)
- ISO 11990‑1 / ISO 11990‑2 / ISO 14408 - guidance on laser airway surgery (relevant for excluded laser-use devices)
Keywords: EN ISO 5361:2023, tracheal tubes, tracheal tube connectors, cuffed tracheal tubes, anaesthetic and respiratory equipment, medical device standards, pediatric tracheal tubes, device testing, ISO standard.