FDA-recognized standard · Ophthalmic

ISO 18369-1: Ophthalmic optics - Contact lenses - Part 1: Vocabulary classification system and recommendations for labelling specifications

Yes. FDA recognizes ISO 18369-1 Second edition 2017-08 as recognition 10-109, entered 2018-06-07.

Recognized editions of ISO 18369-1

FDA recognitions of ISO 18369-1, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
10-109 ISO 18369-1 Second edition 2017-08 2018-06-07 Complete —

Regulations

FDA lists these classification regulations against ISO 18369-1: 21 CFR 886.5916, 21 CFR 886.5925.

Product codes that cite ISO 18369-1

10 FDA product codes cite ISO 18369-1, including HQD, LPL, LPM, MUW, MVN.

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.