Approved Work Item
ISO/AWI TR 22979
Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
Reference number
ISO/AWI TR 22979
Edition 3
© ISO 2025
Approved Work Item
Under development
A working group has prepared a draft.
Will replace ISO/TR 22979:2017

Abstract

ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 3
  • Technical Committee :
    ISO/TC 172/SC 7
  • RSS updates

Life cycle

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