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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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Availability date: 11/05/2021
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
This document provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 172 |
Supersedes |
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