FDA-recognized standard · Radiology
IEC 61674: Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
Yes. FDA recognizes IEC 61674 Edition 3.0 2024-07 as recognition 12-362, entered 2024-12-23. FDA also lists IEC 61674 Edition 2.0 2012-11 (recognition 12-259, transition period ending 2027-12-19).
Recognized editions of IEC 61674
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-362 | IEC 61674 Edition 3.0 2024-07 | 2024-12-23 | Complete | — |
| 12-259 | IEC 61674 Edition 2.0 2012-11 | 2014-01-30 | Complete | 2027-12-19 |
Regulations
FDA lists these classification regulations against IEC 61674: 21 CFR 892.5050, 21 CFR 892.5650, 21 CFR 892.5700, 21 CFR 892.5750, 21 CFR 892.5840, 21 CFR 892.5900, 21 CFR 892.5930.
Product codes that cite IEC 61674
8 FDA product codes cite IEC 61674, including ITZ, IWB, IWD, IWJ, JAD.
- ITZ
- IWB System, Radiation Therapy, Radionuclide
- IWD
- IWJ
- JAD
- JAQ System, Applicator, Radionuclide, Remote-Controlled
- KPQ
- MWW
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.