NF EN ISO 11979-7

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).

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Main informations

Collections

National standards and national normative documents

Publication date

October 2014

Number of pages

47 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 11979-7:2014

European kinship

EN ISO 11979-7:2014
Sumary
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).

Replaced standards (2)
NF EN ISO 11979-7
November 2008
Standard Cancelled
Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations

Le présent document spécifie les exigences particulières relatives aux investigations cliniques sur les lentilles intracculaires (LIO) monofocales de chambres antérieure et postérieure utilisées pour corriger l'aphakie.

NF EN ISO 11979-7/A1
March 2012
Standard Cancelled
Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations - Amendment 1

Le présent document spécifie les exigences particulières relatives aux investigations cliniques sur les lentilles intracculaires (LIO) monofocales de chambres antérieure et postérieure utilisées pour corriger l'aphakie. Il amende la norme NF EN ISO 11979-7:2008 par la modification de l'Annexe B (informative) relative à l'évaluation des niveaux d'effets indésirables et des valeurs d'acuité visuelle postopératoire.

Standard replaced by (1)
NF EN ISO 11979-7
May 2018
Standard Current
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
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Justifications d'une investigation clinique
    1
  • 5 Considérations éthiques
    1
  • 6 Exigences générales
    2
  • Annexe A (informative) Éléments d'une investigation clinique
    7
  • Annexe B (informative) Évaluation des niveaux d'effets indésirables et des valeurs d'acuité visuelle postopératoire
    15
  • Annexe C (informative) Éléments supplémentaires pour les LIO toriques
    19
  • Annexe D (informative) Éléments supplémentaires pour les LIO progressives
    26
  • Annexe E (informative) Essais cliniques
    35
  • Bibliographie
    41
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