Recognized standard
62127-03 Edition 2.0 2022-12
FDA recognition 12-377 · IEC · Radiology
Key facts
| Recognition number | 12-377 |
|---|---|
| Designation | 62127-03 Edition 2.0 2022-12 |
| Title | Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones 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 relevant hydrophone characteristics. This document is applicable to: - hydrophones employing piezoelectric sensor elements, designed to measure the pulsed and continuous wave ultrasonic fields generated by ultrasonic equipment; - hydrophones used for measurements… |
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: