NF EN ISO 11979-6
Ophthalmic implants - Intraocular lenses - Part 6 : shelf-life and transport stability
ISO 11979-6:2007 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.
ISO 11979-6:2007 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.
Le présent document spécifie les essais permettant de déterminer la durée de conservation des lentilles intraoculaires (LIO) stériles dans leur conditionnement final. Ces essais comportent des modes opératoires permettant de vérifier la stabilité des LIO pendant la distribution et le stockage.
<p>ISO 11979-6:2014 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.</p>
- Avant-proposiv
- Introductionv
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions1
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4 Exigences1
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4.1 Généralités1
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4.2 Matériaux et méthodes2
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4.3 Stabilité du produit2
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4.4 Intégrité du conditionnement4
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4.5 Stabilité pendant le transport5
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4.6 Résultats5
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5 Méthodes d'essai et échantillonnage6
- Annexe A (informative) Exemple d'étude de la durée de conservation7
- Annexe B (informative) Essais relatifs aux études de la durée de conservation12
- Bibliographie13
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