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ISO TR 22979 : 2017

M00024411

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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

International Organization for Standardization

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Table of Contents

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Modifications to parent models
5 Considerations for the assignment of modification
  level
6 Modifications of optical design features
7 Modifications to the mechanical design
8 Modifications to material
Annex A (informative) - Examples of modifications
        to a parent IOL model
Annex B (informative) - Mechanical data analysis
Bibliography

Abstract

This document provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 172
Supersedes
  • ISO TR 22979 : 2006