EN ISO 11979-5:2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
01-06-2006
10-11-2020
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements applying to biocompatibility
evaluation of intraocular lenses
5 Physicochemical tests
6 Biological tests
Annex A (normative) Exhaustive extraction test
Annex B (normative) Test for leachables
Annex C (normative) Hydrolytic stability
Annex D (normative) Photostability test
Annex E (normative) Nd-YAG laser exposure test
Annex F (informative) Supplemental conditions of test for
local effects after implantation
Annex G (normative) Ocular implantation test
Bibliography
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.
| Committee |
CEN/TC 170
|
| DevelopmentNote |
Supersedes EN 13503-5 (06/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| I.S. EN ISO 11979-5:2006 | Identical |
| SS-EN ISO 11979-5 : 2006 | Identical |
| DIN EN ISO 11979-5:2010-11 | Identical |
| NBN EN ISO 11979-5 : 2006 | Identical |
| NF EN ISO 11979-5 : 2006 | Identical |
| NEN EN ISO 11979-5 : 2006 | Identical |
| ISO 11979-5:2006 | Identical |
| NS EN ISO 11979-5 : 1ED 2006 | Identical |
| PN EN ISO 11979-5 : 2008 | Identical |
| BS EN ISO 11979-5:2006 | Identical |
| UNE-EN ISO 11979-5:2007 | Identical |