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ISO/TR 22979:2017

Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

Apr 27, 2017

General information

60.60     Apr 27, 2017

ISO

ISO/TC 172/SC 7

Technical Report

11.040.70  

English  

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Scope

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.

Life cycle

PREVIOUSLY

Revises
ISO/TR 22979:2006

NOW

PUBLISHED
ISO/TR 22979:2017
60.60 Standard published
Apr 27, 2017

REVISED BY

IN_DEVELOPMENT
ISO/PWI TR 22979

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