Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Optical requirements
5 Mechanical requirements
6 Biocompatibility requirements
7 Shelf-life and transport stability requirements
8 Fundamental requirements
9 Justification for a clinical investigation
10 General clinical requirements
11 Information supplied by the manufacturer
Annex A (informative) - Elements in a phakic IOL clinical
        investigation
Annex B (informative) - Statistical methods and sample
        size calculations
Bibliography

Abstract

Defines requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power.

Scope

This document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 172
Supersedes	ISO 11979-10 : 2006