I.S. EN ISO 11979-5:2020
Current
The latest, up-to-date edition.
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
Hardcopy , PDF
English
26-10-2020
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 (normative) Supplemental conditions of test for local effects after implantation
Annex G (normative) Ocular implantation test
Bibliography
This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them.
| Committee |
ISO/TC 172
|
| DocumentType |
Standard
|
| Pages |
44
|
| ProductNote |
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 11979-5:2020 | Identical |
| ISO 11979-5:2020 | Identical |
| BS EN ISO 11979-5:2020 | Equivalent |
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