Recognized standard
80601-2-90 First edition 2021-08
FDA recognition 1-196 · ISO · Anesthesiology
Key facts
| Recognition number | 1-196 |
|---|---|
| Designation | 80601-2-90 First edition 2021-08 |
| Title | Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, in combination with its accessories: - intended for use with patients who can breathe spontaneously; and - intended for patients who would benefit from improved alveolar gas exchange; and… |
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: