FDA-recognized standard · Ophthalmic

ISO 18259: Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case challenged with bacterial and fungal organisms

Yes. FDA recognizes ISO 18259 First Edition 2014-10-01 as recognition 10-100, entered 2016-04-04.

Recognized editions of ISO 18259

FDA recognitions of ISO 18259, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
10-100 ISO 18259 First Edition 2014-10-01 2016-04-04 Complete —

Regulations

FDA lists these classification regulations against ISO 18259: 21 CFR 886.5916, 21 CFR 886.5918, 21 CFR 886.5925, 21 CFR 886.5928.

Product codes that cite ISO 18259

11 FDA product codes cite ISO 18259, including HQD, LPL, LPM, LPN, MRC.

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.