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Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of i…

Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of int…

1 Scope 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 i…

Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of i…

Overview ISO/TR 22979:2017 provides guidance for assessing when a clinical investigation is needed after design modifications to intraocular lenses (IOLs). It interprets the application of the ISO 11…