NF EN ISO 11979-7
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.
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
<p>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.</p>
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1 Domaine d'application
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2 Références normatives
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3 Termes, définitions et abréviations
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4 Justifications d'une investigation clinique
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5 Considérations éthiques
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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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