NF EN ISO 11979-9 : 2006 AMD 1 2014
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
12-01-2013
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
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| Status |
Current
|
| Standards | Relationship |
| I.S. EN ISO 11979-9:2006/A1:2014 | Identical |
| DIN EN ISO 11979-9:2014-12 | Identical |
| UNI EN ISO 11979-9 : 2014 | Identical |
| I.S. EN ISO 11979-9:2006 | Identical |
| ISO 11979-9:2006 | Identical |
| BS EN ISO 11979-9 : 2006 | Identical |
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