FDA-recognized standard · Ophthalmic

ISO 11981: Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses

Yes. FDA recognizes ISO 11981 Third edition 2017-11 as recognition 10-111, entered 2018-09-17.

Recognized editions of ISO 11981

FDA recognitions of ISO 11981, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
10-111 ISO 11981 Third edition 2017-11 2018-09-17 Complete —

Regulations

FDA lists these classification regulations against ISO 11981: 21 CFR 886.5916, 21 CFR 886.5918, 21 CFR 886.5925, 21 CFR 886.5928.

Product codes that cite ISO 11981

16 FDA product codes cite ISO 11981, including HQD, HRC, HRD, LPL, LPM.

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.