FDA-recognized standard · Radiology
IEC 60601-2-11: Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
Yes. FDA recognizes IEC 60601-2-11 Edition 3.0 2013-01 as recognition 12-255, entered 2013-08-06.
Recognized editions of IEC 60601-2-11
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-255 | IEC 60601-2-11 Edition 3.0 2013-01 | 2013-08-06 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 60601-2-11: 21 CFR 892.5050, 21 CFR 892.5750.
Product codes that cite IEC 60601-2-11
10 FDA product codes cite IEC 60601-2-11, including IWB, IWD, IWK, IWM, IYE.
- IWB System, Radiation Therapy, Radionuclide
- IWD
- IWK
- IWM
- IYE Accelerator, Linear, Medical
- IYG
- JAE
- LHN System, Radiation Therapy, Charged-Particle, Medical
- MUJ System, Planning, Radiation Therapy Treatment
- 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.