Recognized standard
5366 First edition 2016-10-01
FDA recognition 1-117 · ISO · Anesthesiology
Key facts
| Recognition number | 1-117 |
|---|---|
| Designation | 5366 First edition 2016-10-01 |
| Title | Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 5366:2016 specifies requirements for adult and paediatric tracheostomy tubes and connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support. ISO 5366:2016 is also applicable to specialized tracheostomy tubes that share… |
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: