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NF EN ISO 11979-9 : 2006 AMD 1 2014

Current
Current

The latest, up-to-date edition.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
Published date

01-12-2013

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

Applies 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).

DevelopmentNote
Indice de classement: S94-750-9 PR NF EN ISO 11979-9 May 2005 (05/2005)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Current

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