EN ISO 11979-10:2018

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

ISO 11979-10:2018 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.There are three main categories of phakic intraocular lenses depending on the optical design:a) Phakic monofocal (PIOL);b) Phakic multifocal (PMIOL); andc) Phakic toric (PTIOL).Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye.The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs.ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.