NF EN ISO 11979-5

NF EN ISO 11979-5

October 2006
Standard Cancelled

Ophthalmic implants - Intraocular lenses - Part 5 : biocompatibility

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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Main informations

Collections

National standards and national normative documents

Publication date

October 2006

Number of pages

32 p.

Reference

NF EN ISO 11979-5

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S94-750-5

Print number

1 - 02/10/2006

International kinship

ISO 11979-5:2006

European kinship

EN ISO 11979-5:2006
Sumary
Ophthalmic implants - Intraocular lenses - Part 5 : biocompatibility

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.

Replaced standards (1)
NF EN 13503-5
September 2001
Standard Cancelled
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.

Standard replaced by (1)
NF EN ISO 11979-5
October 2020
Standard Current
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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences générales applicables à l'évaluation de la biocompatibilité des lentilles intraoculaires
    2
  • 5 Essais physicochimiques
    2
  • 6 Essais biologiques
    5
  • Annexe A (normative) Essai d'extraction exhaustive
    7
  • Annexe B (normative) Recherche de composants extractibles
    10
  • Annexe C (normative) Stabilité hydrolytique
    12
  • Annexe D (normative) Essai de photostabilité
    15
  • Annexe E (normative) Essai d'exposition au laser Nd-YAG
    17
  • Annexe F (informative) Conditions supplémentaires d'essai relatives aux effets locaux après implantation
    19
  • Annexe G (normative) Essai d'implantation oculaire
    20
  • Bibliographie
    24
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