Recognized standard
16628 Second edition 2022-06
FDA recognition 1-161 · ISO · Anesthesiology
Key facts
| Recognition number | 1-161 |
|---|---|
| Designation | 16628 Second edition 2022-06 |
| Title | Anaesthetic and respiratory equipment - Tracheobronchial tubes |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | May 29, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required. Tracheal tubes that include bronchus blockers are excluded from the scope of this document. |
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: