M00000159
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ISO TR 22979 2nd Edition, May 1, 2017 Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
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Availability date: 07/13/2021
Description / Abstract: This document 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.