EN ISO 11979-7:2018
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
11-30-2018
05-02-2018
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
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