FDA-recognized standard · Ophthalmic
ISO 11980: Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
Yes. FDA recognizes ISO 11980 Fourth edition 2025-06 as recognition 10-139, entered 2025-12-22. FDA also lists ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01 (recognition 10-85, transition period ending 2027-12-19).
Recognized editions of ISO 11980
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 10-139 | ISO 11980 Fourth edition 2025-06 | 2025-12-22 | Complete | — |
| 10-85 | ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01 | 2019-01-14 | Partial | 2027-12-19 |
What FDA does not recognize in ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01
Recognition 10-85 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: -Table A.1 of Annex A.2.1 Contact lens investigations -Annex A.2.3 Statistical considerations for extended wear evaluations
Regulations
FDA lists these classification regulations against ISO 11980: 21 CFR 886.5916, 21 CFR 886.5918, 21 CFR 886.5925, 21 CFR 886.5928.
Product codes that cite ISO 11980
16 FDA product codes cite ISO 11980, including HQD, HRC, HRD, LPL, LPM.
- HQD Lens, Contact (Other Material) - Daily
- HRC
- HRD
- LPL Lenses, Soft Contact, Daily Wear
- LPM
- LPN Accessories, Soft Lens Products
- LRX
- LYL
- MRC
- MUW
- MVN
- MWL
- MZD
- NCZ
- NIC
- NUU
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.