UNI EN ISO 11979-7 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
30-08-2022
01-01-2015
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
Annex A (informative) - Elements of a clinical
investigation
Annex B (informative) - Evaluation of post-operative
adverse event and visual acuity rates
Annex C (informative) - Additional elements for toric
IOLs
Annex D (informative) - Additional elements for
accommodating IOLs
Annex E (informative) - Clinical tests
Bibliography
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