What is the FDA recognition number for IEC 80601-2-58?

10-136: IEC 80601-2-58 Edition 3.0 2024-03. 10-126: IEC 80601-2-58 Edition 2.0 2014-09.

FDA-recognized standard · Ophthalmic

IEC 80601-2-58: Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

Yes. FDA recognizes IEC 80601-2-58 Edition 3.0 2024-03 as recognition 10-136, entered 2024-05-29. FDA also lists IEC 80601-2-58 Edition 2.0 2014-09 (recognition 10-126, transition period ending 2027-07-04).

Recognized editions of IEC 80601-2-58

FDA recognitions of IEC 80601-2-58, newest first (FDA database snapshot of 2026-09-01)
Recognition	Edition	Entered	Extent	Transition ends
10-136	IEC 80601-2-58 Edition 3.0 2024-03 also ANSI AAMI IEC 80601-2-58:2024	2024-05-29	Complete	—
10-126	IEC 80601-2-58 Edition 2.0 2014-09 also ANSI AAMI IEC 80601-2-58:2014	2021-06-07	Complete	2027-07-04

Regulations

FDA lists these classification regulations against IEC 80601-2-58: 21 CFR 886.4150, 21 CFR 886.4670.

Product codes that cite IEC 80601-2-58

5 FDA product codes cite IEC 80601-2-58, including HKP, HQC, HQE, MLZ, NKX.

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.