FDA-recognized standard · Radiology
IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Yes. FDA recognizes IEC 60601-2-54 Edition 2.0 2022-09 as recognition 12-348, in part, entered 2023-12-18.
Recognized editions of IEC 60601-2-54
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-348 | IEC 60601-2-54 Edition 2.0 2022-09 | 2023-12-18 | Partial | — |
What FDA does not recognize in IEC 60601-2-54 Edition 2.0 2022-09
Recognition 12-348 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: 203.9.101 X-RAY EQUIPMENT specified for RADIOSCOPY 203.9.102 X-RAY EQUIPMENT specified for RADIOGRAPHY
Regulations
FDA lists these classification regulations against IEC 60601-2-54: 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, 21 CFR 892.1980.
Product codes that cite IEC 60601-2-54
18 FDA product codes cite IEC 60601-2-54, including EHB, ITY, IXL, IXQ, IXR.
- EHB
- ITY
- IXL
- IXQ
- IXR
- IZI System, X-Ray, Angiographic
- IZL System, X-Ray, Mobile
- IZO
- IZW
- IZX
- IZZ
- JAA System, X-Ray, Fluoroscopic, Image-Intensified
- KPR System, X-Ray, Stationary
- KPW
- KXJ
- 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.