Recognized standard
18190 Second edition 2025-02
FDA recognition 1-193 · ISO · Anesthesiology
Key facts
| Recognition number | 1-193 |
|---|---|
| Designation | 18190 Second edition 2025-02 |
| Title | Anaesthetic and respiratory equipment - General requirements for airways and related equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the general requirements common to airway devices and related equipment. |
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: