Recognized standard
61223-3-5 Edition 2.0 2019-09
FDA recognition 12-328 · IEC · Radiology
Key facts
| Recognition number | 12-328 |
|---|---|
| Designation | 61223-3-5 Edition 2.0 2019-09 |
| Title | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)] |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 61223 applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016. IEC 60601-2-44 and this document . defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality… |
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: