FDA-recognized standard · Ophthalmic

ISO 11986: Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release

Yes. FDA recognizes ISO 11986 Third edition 2017-11 as recognition 10-112, entered 2018-09-17.

Recognized editions of ISO 11986

FDA recognitions of ISO 11986, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
10-112 ISO 11986 Third edition 2017-11 2018-09-17 Complete —

Regulations

FDA lists these classification regulations against ISO 11986: 21 CFR 886.5916, 21 CFR 886.5918, 21 CFR 886.5925, 21 CFR 886.5928.

Product codes that cite ISO 11986

16 FDA product codes cite ISO 11986, 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.