FDA-recognized standard · Radiology
IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical cosmetic therapeutic and diagnostic laser equipment
Yes. FDA recognizes IEC 60601-2-22 Edition 4.0 2019-11 as recognition 12-356, entered 2024-05-29. FDA also lists IEC 60601-2-22 Edition 3.1 2012-10 (recognition 12-268, transition period ending 2027-07-04).
Recognized editions of IEC 60601-2-22
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-356 | IEC 60601-2-22 Edition 4.0 2019-11 | 2024-05-29 | Complete | — |
| 12-268 | IEC 60601-2-22 Edition 3.1 2012-10 | 2014-01-14 | Complete | 2027-07-04 |
Regulations
FDA lists these classification regulations against IEC 60601-2-22: 21 CFR 878.4810.
Product codes that cite IEC 60601-2-22
10 FDA product codes cite IEC 60601-2-22, including LKW, LLF, LNK, LOI, LPC.
- LKW
- LLF
- LNK
- LOI
- LPC
- LWS
- LZS
- MNO
- MVF
- MVG
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.