NF EN ISO 11979-9

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.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2006

Number of pages

26 p.

Reference

NF EN ISO 11979-9

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S94-750-9

Print number

1 - 04/12/2006

International kinship

ISO 11979-9:2006

European kinship

EN ISO 11979-9:2006
Sumary
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.

Standard replaced by (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
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences physiques
    2
  • 4.1 Généralités
    2
  • 4.2 Tolérances et dimensions
    2
  • 5 Exigences optiques
    2
  • 5.1 Généralités
    2
  • 5.2 Vergence dioptrique
    2
  • 5.3 Qualité d'image
    2
  • 5.4 Qualification optique supplémentaire
    3
  • 6 Investigation clinique
    3
  • 6.1 Généralités
    3
  • 6.2 Exigences supplémentaires applicables au plan d'investigation clinique
    4
  • 7 Informations fournies par le fabricant
    4
  • Annexe A (normative) Qualification optique
    6
  • Annexe B (informative) Investigation clinique
    8
  • Annexe C (informative) Détermination de la taille de l'échantillon pour l'investigation clinique
    16
  • Bibliographie
    20
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