EN ISO 11979-7:2018

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
Annex A (informative) - General elements in the
        clinical investigation of IOLs
Annex B (informative) - Additional elements for the
        clinical investigation of TIOLs
Annex C (informative) - Additional elements for the
        clinical investigation of multifocal IOLs
Annex D (informative) - Additional elements in the
        clinical investigation of accommodating IOLs
Annex E (informative) - Evaluation of post-operative
        adverse events and visual acuity rates
Annex F (informative) - Clinical tests
Annex G (informative) - Statistical methods and
        sample size calculations
Bibliography

ISO 11979-7:2018 specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.