Recognized standard
27427 Fourth edition 2023-07
FDA recognition 1-194 · ISO · Anesthesiology
Key facts
| Recognition number | 1-194 |
|---|---|
| Designation | 27427 Fourth edition 2023-07 |
| Title | Anaesthetic and respiratory equipment - Nebulizing systems and components |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system. This document includes gas-powered nebulizers (which can be… |
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: