I.S. EN ISO 11979-10:2007

National Foreword
European foreword
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

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.