NS EN ISO 11979-5 : 1ED 2006
Withdrawn
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
01-12-2013
10-21-2020
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
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 |
Supersedes NS EN 13503-5. (11/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| EN ISO 11979-5:2006 | Identical |
| ISO 11979-5:2006 | Identical |
| I.S. EN ISO 11979-5:2006 | Identical |
| DIN EN ISO 11979-5:2010-11 | Identical |
| NBN EN ISO 11979-5 : 2006 | Identical |
| BS EN ISO 11979-5:2006 | Identical |
| NF EN ISO 11979-5 : 2006 | Identical |
| NEN EN ISO 11979-5 : 2006 | Identical |
| UNE-EN ISO 11979-5:2007 | Identical |