NF EN ISO 11979-10 : 2006 AMD 1 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES
02-12-2022
12-01-2013
Avant-propos
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Exigences optiques
4.1 Généralités
4.2 Vergence dioptrique
4.3 Qualité de l'image
4.4 Transmission spectrale
5 Exigences mécaniques
6 Investigation clinique
6.1 Généralités
6.2 Évaluations cliniques
6.3 Autres éléments à prendre en considération
7 Informations fournies par le fabricant
Annexe A (informative) Investigation clinique
Annexe B (informative) Études statistiques sur la
taille de l'échantillon
Bibliographie
Applies to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye but excludes phakic IOLs (PIOLs) that utilize multifocal or other simultaneous vision optics to address presbyopic loss of accommodation and PIOLs that correct astigmatism.
| DevelopmentNote |
Indice de classement: S94-750-10PR. PR NF EN ISO 11979-10 May 2005. (05/2005) PR NF EN ISO 11979-10 March 2017. (04/2017)
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| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
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| Status |
Superseded
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| SupersededBy |
| Standards | Relationship |
| ISO 11979-10:2006 | Identical |
| NBN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| NEN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| NS EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| I.S. EN ISO 11979-10:2007 | Identical |
| ONORM EN ISO 11979-10 : 2014 | Identical |
| SN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| UNI EN ISO 11979-10 : 2015 | Identical |
| UNE-EN ISO 11979-10:2007 | Identical |
| BS EN ISO 11979-10 : 2006 | Identical |
| DIN EN ISO 11979-10:2014-12 | Identical |
| EN ISO 11979-10:2018 | Identical |
| NF EN ISO 11979-3 : 2013 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS |
| NF EN ISO 11979-2 : 2014 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS |
| NF EN ISO 14155-2 : 2009 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
| NF EN ISO 11979-4 : 2009 AMD 1 2012 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION |
| NF EN ISO 11979-1 : 2012 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY |
| NF EN ISO 14155-1 : 2009 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
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