FDA-recognized standard · Radiology
IEC 60601-2-1: Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Yes. FDA recognizes IEC 60601-2-1 Edition 4.0 2020-10 as recognition 12-338, entered 2021-06-07.
Recognized editions of IEC 60601-2-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-338 | IEC 60601-2-1 Edition 4.0 2020-10 | 2021-06-07 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 60601-2-1: 21 CFR 892.5050.
Product codes that cite IEC 60601-2-1
9 FDA product codes cite IEC 60601-2-1, including IWK, IWM, IYE, IYG, JAE.
- IWK
- IWM
- IYE Accelerator, Linear, Medical
- IYG
- JAE
- LHN System, Radiation Therapy, Charged-Particle, Medical
- MUJ System, Planning, Radiation Therapy Treatment
- MWW
- NZT
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.