Overview - ISO 16628:2022 (Tracheobronchial tubes)
ISO 16628:2022 sets safety, material, design and information requirements for tracheobronchial tubes - double‑lumen tracheal tubes used to isolate one or both lungs for selective ventilation (commonly used in thoracic surgery and when protecting a lung from bleeding or air leaks). The standard covers sizing, dimensional tolerances, connectors, cuff systems, biological safety testing and required labelling/packaging. (Tracheal tubes that include bronchus blockers are excluded.)
Key technical topics and requirements
- Scope and purpose: Requirements apply to double‑lumen tracheobronchial tubes used to isolate airways of one lung from the other.
- Designated size (French/Charrière): Designated size is based on the tracheal segment outside diameter (OD) calculated from the average of the major and minor axis. The standard relates OD to French size (Fr = 3 × OD [mm]) and specifies tolerances for dimensional accuracy.
- Dimensions tolerances: Major and minor axis lengths across the tracheal OD have a tolerance of ±0.5 mm.
- Connectors: Machine‑end connectors shall be 15 mm conical cones conforming to ISO 5356‑1. Cuff inflation inlets shall be compatible with the L1 male Luer slip small‑bore connector per ISO 80369‑7.
- Cuffs and inflation systems: Cuffs must be integrally attached and leak‑free. Leak testing is specified (inflate to 9.0 kPa / 90 cm H2O or 1.5× cuff diameter per ISO 5361 test, submerge and observe for bubbles). Cuff diameters shall be within ±15% of marked value; herniation tests per ISO 5361 Annex D are required. Cuff inflation systems must meet ISO 5361:2016 requirements.
- Materials / biocompatibility: Materials must meet general requirements of ISO 18190 and biological safety testing per ISO 18562‑1.
- Information, marking & packaging: Manufacturer labelling, colour coding, durability and sterile supply requirements are specified (Clause 9).
- Test methods & annexes: Annex B - outside diameter test for bronchial segment; Annex C - test for effective inside diameters.
Practical applications and users
- Clinical use: thoracic and cardiothoracic surgery, one‑lung ventilation, airway protection during pulmonary hemorrhage or major air leak.
- Primary users of the standard: medical device manufacturers, R&D and design engineers, conformity assessors, regulatory affairs teams, hospital procurement, anesthesiologists, respiratory therapists and clinical engineers involved in device selection, testing and maintenance.
Related standards
- ISO 18190 - General requirements for airways and related equipment
- ISO 5361 - Tracheal tubes and connectors (cuff tests and inflation system)
- ISO 18562‑1 - Biocompatibility of breathing gas pathways
- ISO 5356‑1 - Conical connectors (15 mm)
- ISO 80369‑7 - Small‑bore connectors (Luer slip)
Keywords: ISO 16628:2022, tracheobronchial tubes, double‑lumen tube, anaesthetic and respiratory equipment, bronchial cuff, one‑lung ventilation, ISO 18190, ISO 5361.
