Recognized standard
11195 Second edition 2018-01
FDA recognition 1-166 · ISO · Anesthesiology
Key facts
| Recognition number | 1-166 |
|---|---|
| Designation | 11195 Second edition 2018-01 |
| Title | Gas mixers for medical use - Stand-alone gas mixers |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | SO 11195:2018 specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use. ISO 11195:2018 does not apply to: a) blocks of flowmeters with separate controls for the flow of each gas; b) stand-alone gas mixers which mix… |
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: