Recognized standard
61846 First edition 1998-04
FDA recognition 9-7 · IEC · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-7 |
|---|---|
| Designation | 61846 First edition 1998-04 |
| Title | Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
| Standards developer | International Electrotechnical Commission |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Sep 9, 2008 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard is applicable to - lithotripsy equipment using extracorporeally induced pressure waves; - lithotripsy equipment producing focused mechanical energy. This International Standard does not apply to percutaneous and laser lithotripsy equipment. This International Standard… |
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: