EN ISO 11979-7:2018
Withdrawn
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)
05-02-2018
11-30-2018
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Withdrawn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 |
| Standards | Relationship |
| NF EN ISO 11979-7:2018 | Identical |
| SS-EN ISO 11979-7:2018 | Identical |
| BS EN ISO 11979-7:2018 | Identical |
| BS EN ISO 11979-7:2014 | Identical |
| NEN EN ISO 11979-7 : 2014 | Identical |
| DIN EN ISO 11979-7:2014-12 | Identical |
| I.S. EN ISO 11979-7:2014 | Identical |
| NBN EN ISO 11979-7 : 2014 | Identical |
| NF EN ISO 11979-7 : 2014 | Identical |
| PN EN ISO 11979-7 : 2015 | Identical |
| NEN-EN-ISO 11979-7:2018 | Identical |
| NS EN ISO 11979-7 : 2014 | Identical |
| DIN EN ISO 11979-7:2018-08 | Identical |
| ISO 11979-7:2014 | Identical |
| ISO 11979-7:2018 | Identical |
| DS EN ISO 11979-7 : 2014 | Identical |
| DS/EN ISO 11979-7:2018 | Identical |
| SS-EN ISO 11979-7:2024 | Identical |
| PN-EN ISO 11979-7: 2018 | Identical |
| BS EN ISO/ASTM 52911-3:2023 | Identical |
| I.S. EN ISO 11979-7:2018:COR 2018 | Identical |
| UNE-EN ISO 11979-7:2018 | Identical |
| 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 |