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FDA-recognized standard · Ophthalmic

ISO 11979-8: Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements

Yes. FDA recognizes ISO 11979-8 Third edition 2017-04 as recognition 10-105, entered 2018-06-07.

Recognized editions of ISO 11979-8

FDA recognitions of ISO 11979-8, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
10-105 ISO 11979-8 Third edition 2017-04 2018-06-07 Complete —

Regulations

FDA lists these classification regulations against ISO 11979-8: 21 CFR 886.3600.

Product codes that cite ISO 11979-8

6 FDA product codes cite ISO 11979-8, including HQL, MFK, MJP, NAA, NIZ.

  • HQL
  • MFK
  • MJP
  • NAA
  • NIZ
  • POE

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.