NF EN ISO 11979-5 : 2006

Withdrawn

View Superseded by

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY

Withdrawn date

09-30-2021

Published date

01-12-2013

Publisher

Association Francaise de Normalisation

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

Specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. It also gives guidance on conducting an ocular implantation test.

DevelopmentNote	Indice de classement: S94-750-5 PR NF EN ISO 11979-5 November 2004. (11/2004) Supersedes NF EN 13503-5. (11/2006)
DocumentType	Standard
PublisherName	Association Francaise de Normalisation
Status	Withdrawn
SupersededBy	NF EN ISO 11979-5:2020

Standards	Relationship
EN ISO 11979-5:2006	Identical
ISO 11979-5:2006	Identical
I.S. EN ISO 11979-5:2006	Identical
NS EN ISO 11979-5 : 1ED 2006	Identical
SN EN ISO 11979-5 : 2006	Identical
UNI EN ISO 11979-5 : 2006	Identical
DIN EN ISO 11979-5:2010-11	Identical
NBN EN ISO 11979-5 : 2006	Identical
UNE-EN ISO 11979-5:2007	Identical
BS EN ISO 11979-5:2006	Identical
ONORM EN ISO 11979-5 : 2010	Identical
NEN EN ISO 11979-5 : 2006	Identical
DIN EN ISO 11979-5 E : 2010	Identical

NF EN ISO 10993-12 : 2012	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
NF EN ISO 11979-3 : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
NF EN ISO 10993-1 : 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS
NF EN ISO 11979-2 : 2014	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS
NF EN ISO 10993-3 : 2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
NF EN ISO 10993-2 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
NF EN ISO 11979-1 : 2012	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY
NF EN ISO 10993-6 : 2017	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
NF EN ISO 10993-10 : 2013	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION