Recognized standard
61847: 1998
FDA recognition 12-121 · IEC · Radiology
Key facts
| Recognition number | 12-121 |
|---|---|
| Designation | 61847: 1998 |
| Title | Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0 |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 27, 2005 |
| Scope (excerpt) | This International Standard specifies: - the essential non-thermal output characteristics of ultrasonic surgical units; NOTE 1 - One of the parameters of interest is output acoustic power. This standard addresses only the lowfrequency (under 100 kHz) component of the total delivered energy. The… |
At a glance
- None 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: