I.S. EN 13503-5:2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY
Hardcopy , PDF
04-08-2006
English
01-01-2001
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.
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1 Scope
2 Normative references
3 Terms and definitions
4 General requirements applying to the biological evaluation
of intraocular lenses
5 Physicochemical tests
5.1 General
5.2 Test of extractables and hydrolytic stability
5.3 Degradation tests
Annex A (normative) Test for extractables and hydrolytic
stability
Annex B (normative) Test of photostability
Annex C (normative) Nd-YAG laser exposure test
Annex D (normative) Ocular implantation test
Annex E (informative) Selected definitions
Annex F (informative) A-deviations
Annex ZA (informative) A-deviations
Bibliography
Covers particular requirements for the biological evaluation of intraocular lenses (IOLs) which are in addition to the requirements outlined in the relevant parts of EN ISO 10993. Also gives guidance on conducting an ocular implantation test.
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NS EN 13503-5 : 1ED 2001 | Identical |
| NBN EN 13503-5 : 2001 | Identical |
| NEN EN 13503-5 : 2001 | Identical |
| BS EN 13503-5:2001 | Identical |
| EN 13503-5 : 2001 | Identical |
| NF EN 13503-5 : 2001 | Identical |
| SN EN 13503-5 : 2001 | Identical |
| UNE-EN 13503-5:2001 | Identical |
| UNI EN 13503-5 : 2001 | Identical |
| DIN EN 13503-5:2001-07 | Identical |
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