Recognized standard
62127-2 Edition 2.0 2025-01
FDA recognition 12-379 · IEC · Radiology
Key facts
| Recognition number | 12-379 |
|---|---|
| Designation | 62127-2 Edition 2.0 2025-01 |
| Title | Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 62127 specifies: - absolute hydrophone calibration methods; - relative (comparative) hydrophone calibration methods. Recommendations and references to accepted literature are made for the various relative andabsolute calibration methods in the frequency range covered by this… |
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: