Recognized standard
62127-1 Edition 2.0 2022-03
FDA recognition 12-343 · IEC · Radiology
Key facts
| Recognition number | 12-343 |
|---|---|
| Designation | 62127-1 Edition 2.0 2022-03 |
| Title | Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 30, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 62127 specifies methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment including bandwidth criteria and calibration frequency range requirements in dependence on the spectral content of the fields to 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: