FDA-recognized standard · Radiology
IEC 61223-3-8: 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
Yes. FDA recognizes IEC 61223-3-8 Edition 1.0 2024-03 as recognition 12-364, entered 2024-12-23.
Recognized editions of IEC 61223-3-8
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-364 | IEC 61223-3-8 Edition 1.0 2024-03 | 2024-12-23 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 61223-3-8: 21 CFR 872.1840, 21 CFR 892.1600, 21 CFR 892.1610, 21 CFR 892.1650, 21 CFR 892.1670, 21 CFR 892.1680, 21 CFR 892.1700, 21 CFR 892.1720, 21 CFR 892.1760.
Product codes that cite IEC 61223-3-8
14 FDA product codes cite IEC 61223-3-8, including EHB, ITY, IXL, IZI, IZL.
- EHB
- ITY
- IXL
- IZI System, X-Ray, Angiographic
- IZL System, X-Ray, Mobile
- IZO
- IZW
- IZX
- JAA System, X-Ray, Fluoroscopic, Image-Intensified
- KPR System, X-Ray, Stationary
- KPW
- MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
- OWB Interventional Fluoroscopic X-Ray System
- OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.