10xAnd
Scoping review

FDA-recognized standard · Ophthalmic

ISO 11979-2: Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods

Yes. FDA recognizes ISO 11979-2 Third edition 2024-10 as recognition 10-137, entered 2025-05-26. FDA also lists ISO 11979-2 Second edition 2014-08-15 (recognition 10-98, transition period ending 2027-07-04).

Recognized editions of ISO 11979-2

FDA recognitions of ISO 11979-2, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
10-137 ISO 11979-2 Third edition 2024-10 2025-05-26 Complete —
10-98 ISO 11979-2 Second edition 2014-08-15 2015-08-14 Complete 2027-07-04

Regulations

FDA lists these classification regulations against ISO 11979-2: 21 CFR 886.3600.

Product codes that cite ISO 11979-2

7 FDA product codes cite ISO 11979-2, including HQL, MFK, MJP, MTA, NAA.

  • HQL
  • MFK
  • MJP
  • MTA
  • NAA
  • NIZ
  • POE

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.