NF EN ISO 11979-6

NF EN ISO 11979-6

September 2007
Standard Cancelled

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.

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National standards and national normative documents

Publication date

September 2007

Number of pages

21 p.

Reference

NF EN ISO 11979-6

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S94-750-6

Print number

1 - 27/09/2007

International kinship

ISO 11979-6:2007

European kinship

EN ISO 11979-6:2007
Sumary
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.

Replaced standards (1)
NF EN 13503-6
March 2003
Standard Cancelled
Ophthalmic implants - Intraocular lenses - Part 6 : shelf-life and transport stability

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.

Standard replaced by (1)
NF EN ISO 11979-6
December 2014
Standard Current
Ophtalmic implants - Intraocular lenses - Part 6 : shelf-life and transport stability testing

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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences
    1
  • 4.1 Généralités
    1
  • 4.2 Matériaux et méthodes
    2
  • 4.3 Stabilité du produit
    2
  • 4.4 Intégrité du conditionnement
    4
  • 4.5 Stabilité pendant le transport
    5
  • 4.6 Résultats
    5
  • 5 Méthodes d'essai et échantillonnage
    6
  • Annexe A (informative) Exemple d'étude de la durée de conservation
    7
  • Annexe B (informative) Essais relatifs aux études de la durée de conservation
    12
  • Bibliographie
    13
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