NF EN ISO 11979-5
Ophthalmic implants - Intraocular lenses - Part 5 : biocompatibility
This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.
This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.
ISO 11979-5:2006 specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.
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1 Domaine d'application
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2 Références normatives
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3 Termes et définitions
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4 Exigences générales applicables à l'évaluation de la biocompatibilité des lentilles intraoculaires
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5 Essais physicochimiques
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6 Essais biologiques
- Annexe A Essai d'extraction exhaustive
- Annexe B Essai des substances relargables
- Annexe C Stabilité hydrolytique
- Annexe D Essai de photostabilité
- Annexe E Essai d'exposition au laser Nd-YAG
- Annexe F Conditions supplémentaires d'essai relatives aux effets locaux après implantation
- Annexe G Essai d'implantation oculaire
- Bibliographie
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