NF EN ISO 11979-5 : 2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
30-09-2021
12-01-2013
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)
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| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Withdrawn
|
| SupersededBy |
| 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 |
| 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 |
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