FDA-recognized standard · Ophthalmic
ISO 18189: Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
Yes. FDA recognizes ISO 18189 First edition 2016-06-01 as recognition 10-101, entered 2016-09-21.
Recognized editions of ISO 18189
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 10-101 | ISO 18189 First edition 2016-06-01 | 2016-09-21 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 18189: 21 CFR 886.5916, 21 CFR 886.5925.
Product codes that cite ISO 18189
8 FDA product codes cite ISO 18189, including HQD, LPL, LPM, MUW, MWL.
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.