ISO-22979 Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

ISO-22979 - 2ND EDITION - CURRENT
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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.

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Document Number

ISO/TR 22979:2017

Revision Level

2ND EDITION

Status

Current

Publication Date

May 1, 2017

Committee Number

ISO/TC 172/SC 7