Overview
EN ISO 16628:2022 - Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022) specifies requirements for the safety, materials, design and information supplied with tracheobronchial tubes (double‑lumen tracheal tubes used for lung isolation). Published as a CEN‑endorsed ISO standard in 2022, this second edition replaces the 2008 edition and aligns the standard with general airway device requirements (ISO 18190). Note: tracheal tubes that include bronchus blockers are excluded from the scope.
Key topics and requirements
The standard covers technical and safety aspects critical to manufacturers, test laboratories and regulatory reviewers. Main topics include:
- General safety and risk management expectations, consistent with medical device risk practices.
- Materials and biocompatibility obligations, including reference to breathing‑gas pathway evaluation (e.g., ISO 18562 series).
- Design requirements for double‑lumen tracheobronchial tubes: designated size, dimensions, bronchial segment geometry and cuff design.
- Cuff and cuff inflation system characteristics and associated design considerations.
- Connectors and compatibility (referencing conical connectors and connector standards).
- Performance testing and dimensional tests, with normative annexes (test methods for bronchial segment outside diameter and effective inside diameters).
- Packaging, sterility and information supplied - marking, colour coding, durability and labelling requirements.
- Documentation requirements including manufacturer information, instructions for use and risk management records.
Practical applications
EN ISO 16628:2022 is directly applicable where reliable lung isolation and selective ventilation are required:
- Use in perioperative and intensive care settings for one‑lung ventilation, protection from cross‑contamination or selective lung management.
- Guidance for product design and verification of double‑lumen tracheal tubes and associated components.
- Basis for conformity assessment, CE marking and national regulatory compliance in countries adopting the EN ISO version.
Who should use this standard
- Medical device manufacturers designing, producing or marketing tracheobronchial tubes.
- Test laboratories and notified bodies performing performance and safety evaluations.
- Regulatory and procurement teams specifying device acceptance criteria.
- Clinicians and biomedical engineers seeking to understand device labelling, sizing and safe use.
Related standards
EN ISO 16628:2022 references and aligns with several standards relevant to airway devices, including:
Using EN ISO 16628:2022 helps ensure tracheobronchial tubes meet recognized safety, design and information standards for clinical use and regulatory compliance.
