PD ISO/TR 22979:2017

This standard PD ISO/TR 22979:2017 Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications is classified in these ICS categories:

• 11.040.70 Ophthalmic equipment

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.