NBN EN ISO 11979-5 : 2006
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
12-01-2013
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 NBN EN 13503-5. (12/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN ISO 11979-5 : 2006 | Identical |
| EN ISO 11979-5:2006 | Identical |
| NF EN ISO 11979-5 : 2006 | Identical |
| NS EN ISO 11979-5 : 1ED 2006 | Identical |
| DIN EN ISO 11979-5:2010-11 | Identical |
| I.S. EN ISO 11979-5:2006 | Identical |
| BS EN ISO 11979-5:2006 | Identical |
| ONORM EN ISO 11979-5 : 2010 | Identical |
| ISO 11979-5:2006 | Identical |
| SN EN ISO 11979-5 : 2006 | Identical |
| UNE-EN ISO 11979-5:2007 | Identical |
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