NF EN ISO 11979-7

NF EN ISO 11979-7

May 2018
Standard Cancelled

Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations of intraocular lenses for the correction of aphakia

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.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2018

Number of pages

54 p.

Reference

NF EN ISO 11979-7

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S94-750-7

Print number

1

International kinship

ISO 11979-7:2018

European kinship

EN ISO 11979-7:2018
Sumary
Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations of intraocular lenses for the correction of aphakia

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.

Replaced standards (3)
NF EN ISO 11979-7
October 2014
Standard Cancelled
Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations

ISO 11979-7:2014 specifies particular requirements for clinical investigations for posterior and anterior chamber intraocular lenses (IOLs).

NF EN ISO 11979-9
December 2006
Standard Cancelled
Ophthalmic implants - Intraocular lenses - Part 9 : multifocal intraocular lenses

ISO 11979-9:2006 is applicable to any intraocular lens whose optic provides two or more rotationally symmetric powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near). The term "near vision" as used in ISO 11979-9:2006 includes useful vision at a distance of claimed benefit; e.g. near and/or intermediate distances.

NF EN ISO 11979-9/A1
October 2014
Standard Cancelled
Ophthalmic implants - Intraocular lenses - Part 9 : multifocal intraocular lenses - Amendment 1

Le présent document amende la norme homologuée NF EN ISO 11979-9:2006 par une mise à jour des articles 1 (domaine d'application), 2 (références normatives), 3 (termes et définitions), 4 (exigences physiques), 5 (exigences optiques), 6 (investigation clinique) et 7 (informations fournies par le fabricant), ainsi que l'annexe A (qualification optique).

Standard replaced by (1)
NF EN ISO 11979-7
January 2024
Standard Current
Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations of intraocular lenses for the correction of aphakia

This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes, définitions et abréviations
  • 4 Justifications d'une investigation clinique
  • 5 Considérations éthiques
  • 6 Exigences générales
  • Annexe A Éléments généraux de l'investigation clinique des LIO
  • Annexe B Éléments supplémentaires de l'investigation clinique des LIOT
  • Annexe C Éléments supplémentaires de l'investigation clinique des LIO multifocales
  • Annexe D Éléments supplémentaires de l'investigation clinique des LIO accommodatives
  • Annexe E Évaluation des taux d'effets indésirables et d'acuité visuelle postopératoires
  • Annexe F Essais cliniques
  • Annexe G Méthodes statistiques et calculs de l'effectif de l'échantillon
  • Bibliographie
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