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.

See more
View the extract
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
New: UPSELL service
- The UPSELL service allows you to easily update one of your standards.
- With a single click, add a new language, the Requirements or Redline+ service and add one or more additional users.
- Whether you are in the process of acquiring a standard or it is already available in your personal space, the UPSELL service is available at every stage to help you understand it and implement it within your organization.
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ