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BS PD ISO/TR 22979 : 2017

M00020604

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BS PD ISO/TR 22979 : 2017

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - GUIDANCE ON ASSESSMENT OF THE NEED FOR CLINICAL INVESTIGATION OF INTRAOCULAR LENS DESIGN MODIFICATIONS

British Standards Institution

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Table of Contents

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

Abstract

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

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Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/172/7