Recognized standard
61161 Edition 3.0 2013-01
FDA recognition 12-275 · IEC · Radiology
Key facts
| Recognition number | 12-275 |
|---|---|
| Designation | 61161 Edition 3.0 2013-01 |
| Title | Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | IEC 61161:2013 specifies a method of determining the total emitted acoustic power of ultrasonic transducers based on the use of a radiation force balance; establishes general principles for the use of radiation force balances in which an obstacle (target) intercepts the sound field to be measured… |
At a glance
- 10–99 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: