NF EN ISO 11979-7:2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
Hardcopy
12-02-2024
English - French
13-07-2018
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1 Scope
2 Normative references
3 Terms, definitions and abbreviations
4 Justifications for a clinical investigation
5 Ethical considerations
6 General requirements
Appendix A General Elements of the Clinical Investigation of IOLs
Appendix B Additional Elements of the Clinical Investigation of the LIOTs
Appendix C Additional Elements of Clinical Investigation of Multifocal IOLs
Appendix D Additional Elements of the Clinical Investigation of Accommodative IOLs
Appendix E Evaluation of Postoperative Adverse Reaction and Visual Acuity Rates
Appendix F Clinical Trials
Appendix G Statistical Methods and Sample Size Calculations
Bibliography
Scope This document specifies the specific requirements for clinical investigations of intraocular lenses intended to be implanted in the eye to correct aphakia.
| DocumentType |
Standard
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| Pages |
0
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11979-7:2018 | Identical |
| EN ISO 11979-7:2018 | Identical |
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