NF EN ISO 11979-7

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.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2024

Number of pages

60 p.

Reference

NF EN ISO 11979-7

ICS Codes

11.040.70   Ophthalmic equipment
11.100.20   Biological evaluation of medical devices

Classification index

S94-750-7

Print number

1

International kinship

ISO 11979-7:2024

European kinship

EN ISO 11979-7:2024
Sumary
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.

Replaced standards (1)
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.

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
  • A Éléments généraux de l'investigation clinique des LIO
  • B Éléments supplémentaires de l'investigation clinique des LIO toriques
  • C Éléments supplémentaires de l'investigation clinique des LIO à champ de vision simultané (LIOCVS)
  • D Éléments supplémentaires de l'investigation clinique des LIO accommodatives
  • E Évaluation des taux d'effets indésirables et d'acuité visuelle postopératoires
  • F Essais cliniques
  • G Méthodes statistiques et calculs de l'effectif de l'échantillon
  • Bibliographie
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