Recognized standard
62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION
FDA recognition 12-291 · IEC · Radiology
Key facts
| Recognition number | 12-291 |
|---|---|
| Designation | 62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION |
| Title | Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2 |
| Scope (excerpt) | IEC 62127-2:2007+A1:2013+A2:2017 specifies absolute hydrophone calibration methods and relative (comparative) hydrophone calibration methods. This standard is applicable to: - hydrophones used for measurements made in water and in the ultrasonic frequency range up to 40 MHz; - hydrophones employing… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: