Overview
EN ISO 5366:2016 - Anaesthetic and respiratory equipment: Tracheostomy tubes and connectors (ISO 5366:2016) specifies essential requirements for adult and paediatric tracheostomy tubes and connectors. It covers both cuffed and uncuffed designs and many specialized variants (reinforced walls, metal tubes, tapering tubes, tubes with shoulders, or those providing suctioning, monitoring or drug/gas delivery). The standard defines design, material, labelling, packaging and sterile-supply expectations to support safe use during anaesthesia, artificial ventilation and other respiratory support.
Key topics and technical requirements
- Scope and definitions: Classification for paediatric and adult tracheostomy tubes; size designated by internal dimension and outside dimension to aid clinical selection.
- Materials: Requirements and guidance on biocompatible materials suitable for prolonged airway use.
- Design features:
- Connector: requirements for compatibility and secure attachment (test methods included).
- Neck plate, inner tube and introducer: dimensional and functional expectations.
- Cuffs and inflating systems: design, cuff diameter determination and herniation test methods; cuff inflation indicators and marking requirements.
- Radiopaque markers: visibility for imaging.
- Kink resistance: specified test method to assess shaft collapse and breathing resistance when bent.
- Sterility and packaging: requirements for tracheostomy tubes supplied sterile, sterility assurance and unit-pack labelling.
- Information and labelling: mandatory markings on neck plates, inflation indicators and connectors; additional unit-pack labelling details to support clinical use and traceability.
- Test methods and annexes: normative annexes include tests for connector attachment, cuff diameter, cuff herniation and kink resistance; informative annexes provide rationale, material/design guidance and hazard identification for risk assessment.
Practical applications and users
Who benefits from EN ISO 5366:2016:
- Medical device manufacturers - design, test, certify and label tracheostomy tubes and connectors to meet regulatory and market requirements.
- Product designers and R&D teams - implement cuff, connector and material specifications and test methods (e.g., kink resistance, cuff tests).
- Clinical engineers and procurement - select appropriate tubes (size, cuff type, radiopacity) for adult and paediatric use and verify compliance.
- Regulatory bodies and testing laboratories - perform conformity assessment and validation against the standard.
- Clinicians (anaesthetists, intensivists, ENT specialists, respiratory therapists) - use standardized sizing and labelling information to match device choice to patient anatomy and ventilation needs.
Related standards
- ISO 18190 - cross-referenced for requirements common to airway devices.
- ISO/TR 11991 - guidance on avoidance of airway fires (flammability hazards are recognized but outside ISO 5366:2016’s scope).
Keywords: tracheostomy tubes, tracheostomy connectors, ISO 5366:2016, cuffed tracheostomy tube, paediatric tracheostomy, kink resistance, sterility, radiopaque marker.
