Recognized standard
61223-3-8 Edition 1.0 2024-03
FDA recognition 12-364 · IEC · Radiology
Key facts
| Recognition number | 12-364 |
|---|---|
| Designation | 61223-3-8 Edition 1.0 2024-03 |
| Title | Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This part of IEC 61223 applies to evaluation of the imaging performance and related QUALITY CONTROL parameters of X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY that conform to IEC 60601-2-54:2022 or IEC 60601-2-43:2022. NOTE Cone-beam CT is a MODE OF OPERATION in INTERVENTIONAL X-RAY EQUIPMENT… |
At a glance
- 10–99 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: