FDA-recognized standard · Radiology
IEC 62083: Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Yes. FDA recognizes IEC 62083 Edition 2.0 2009-09 as recognition 12-217, entered 2011-03-14.
Recognized editions of IEC 62083
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-217 | IEC 62083 Edition 2.0 2009-09 | 2011-03-14 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 62083: 21 CFR 892.5050, 21 CFR 892.5750, 21 CFR 892.5900.
Product codes that cite IEC 62083
21 FDA product codes cite IEC 62083, including IWB, IWD, IWK, IWM, IYC.
- IWB System, Radiation Therapy, Radionuclide
- IWD
- IWK
- IWM
- IYC
- IYD
- IYE Accelerator, Linear, Medical
- IYG
- IYH
- IYI
- IYJ
- IYK
- IYL
- JAD
- JAE
- KPZ
- KQA
- 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.