NF EN 13503-5
Ophthalmic implants - Intraocular lenses - Part 5 : biocompatibility
Le présent document spécifie les exigences particulières d'évaluation biologique des lentilles intraoculaires (LIOs) en complément des exigences définies dans les parties correspondantes de la NF EN ISO 10993. Il donne aussi des lignes directrices pour conduire un essai d'implantation oculaire.
Le présent document spécifie les exigences particulières d'évaluation biologique des lentilles intraoculaires (LIOs) en complément des exigences définies dans les parties correspondantes de la NF EN ISO 10993. Il donne aussi des lignes directrices pour conduire un essai d'implantation oculaire.
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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