FDA-recognized standard · Ophthalmic
ISO 18369-2: Ophthalmic optics - Contact lenses - Part 2: Tolerances
Yes. FDA recognizes ISO 18369-2 Third edition 2017-08 as recognition 10-108, in part, entered 2019-01-14.
Recognized editions of ISO 18369-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 10-108 | ISO 18369-2 Third edition 2017-08 | 2019-01-14 | Partial | — |
What FDA does not recognize in ISO 18369-2 Third edition 2017-08
Recognition 10-108 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Section 6 Tolerances for soft contact lenses, Paragraphs 3, 4 and 5.
Regulations
FDA lists these classification regulations against ISO 18369-2: 21 CFR 886.5916, 21 CFR 886.5925.
Product codes that cite ISO 18369-2
10 FDA product codes cite ISO 18369-2, including HQD, LPL, LPM, MUW, MVN.
- HQD Lens, Contact (Other Material) - Daily
- LPL Lenses, Soft Contact, Daily Wear
- LPM
- 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.