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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)
30-11-2018
02-05-2018
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.
| Committee |
CEN/TC 170
|
| DevelopmentNote |
Supersedes EN 13503-7 (05/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Supersedes |
| ISO 11979-10:2006 | Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses |
| ISO/TR 22979:2017 | Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| ISO 11979-1:2006 | Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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