| ISO 16628 First edition 2008-11-15 Tracheobronchial tubes-Sizing and marking |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 1-127 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 16628:2008 provides requirements for designation and labelling of tracheobronchial tubes, including colour coding of the bronchial cuff and its associated pilot balloon. Tracheobronchial tubes that include bronchus blockers are excluded from the scope of ISO 16628:2008.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5740 | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | Class 2 | CBI |
| There is no relevant guidance developed at this time. |