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FDA-recognized standard · Ophthalmic

ISO 11979-5: Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility

Yes. FDA recognizes ISO 11979-5 Third edition 2020-09 as recognition 10-119, entered 2020-12-21.

Recognized editions of ISO 11979-5

FDA recognitions of ISO 11979-5, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
10-119 ISO 11979-5 Third edition 2020-09 2020-12-21 Complete —

Regulations

FDA lists these classification regulations against ISO 11979-5: 21 CFR 886.3600.

Product codes that cite ISO 11979-5

7 FDA product codes cite ISO 11979-5, including HQL, MFK, MJP, MTA, NAA.

  • HQL
  • MFK
  • MJP
  • MTA
  • 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.