Recognized standard
5361 Third edition 2016-09-01
FDA recognition 1-118 · ISO · Anesthesiology
Key facts
| Recognition number | 1-118 |
|---|---|
| Designation | 5361 Third edition 2016-09-01 |
| Title | Anaesthetic and respiratory equipment - Tracheal tubes and connectors |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 23, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 5361:2016 provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning… |
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: