Recognized standard
16628 First edition 2008-11-15
FDA recognition 1-127 · ISO · Anesthesiology
Key facts
| Recognition number | 1-127 |
|---|---|
| Designation | 16628 First edition 2008-11-15 |
| Title | Tracheobronchial tubes-Sizing and marking |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | 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. |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: