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BSI PD ISO/TR 22979:2017

Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
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BSI PD ISO/TR 22979:2017

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

PUBLISH DATE 2017
PAGES 28
BSI PD ISO/TR 22979:2017

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.

SDO BSI: British Standards Institution
Document Number ISO/TR 22979
Publication Date Sept. 21, 2017
Language en - English
Page Count
Revision Level
Supercedes
Committee CH/172/7
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