17/30336158 DC : 0
NA
Status of Standard is Unknown
Hardcopy , PDF
English
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 toric IOLs
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
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