Recognized standard
61223-2-6 Second Edition 2006-11
FDA recognition 12-226 · IEC · Radiology
Key facts
| Recognition number | 12-226 |
|---|---|
| Designation | 61223-2-6 Second Edition 2006-11 |
| Title | Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment |
| 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 provides assistance in performing CONSTANCY TESTS on a CT SCANNER. It applies to those components of CT SCANNERS which influence the image quality, PATIENT dose and positioning. This standard - defines the essential parameters which describe the performance of CT SCANNERS with… |
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: