Recognized standard
61223-3-4 First edition 2000-03
FDA recognition 12-221 · IEC · Radiology
Key facts
| Recognition number | 12-221 |
|---|---|
| Designation | 61223-3-4 First edition 2000-03 |
| Title | Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Mar 14, 2011 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 61223 applies to those components of dental X-RAY EQUIPMENT using radiographic imaging systems which influence the image quality and PATIENT dose. This standard applies to the performance of the ACCEPTANCE TEST on dental X-RAY EQUIPMENT with intra-oral X-RAY IMAGE RECEPTOR and… |
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: