I.S. 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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by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
Hardcopy , PDF
English
01-01-2006
30-04-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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 I.S. EN 13503-5. (08/2006)
|
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 11979-5:2006 | Identical |
| ISO 11979-5:2006 | Identical |
| NS EN ISO 11979-5 : 1ED 2006 | 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 |
| DIN EN ISO 11979-5:2010-11 | Identical |
| UNE-EN ISO 11979-5:2007 | Identical |
A newer version of this standard is available.
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