FDA-recognized standard · Ophthalmic

ISO 11979-3: Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods

Yes. FDA recognizes ISO 11979-3 Third edition 2012-12-01 as recognition 10-78, entered 2013-08-06.

Recognized editions of ISO 11979-3

FDA recognitions of ISO 11979-3, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
10-78 ISO 11979-3 Third edition 2012-12-01 2013-08-06 Complete —

Regulations

FDA lists these classification regulations against ISO 11979-3: 21 CFR 886.3600, 21 CFR 886.4300.

Product codes that cite ISO 11979-3

8 FDA product codes cite ISO 11979-3, including HQL, KYB, MFK, MJP, MSS.

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.