EN 13503-5 : 2001
Superseded
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY
01-12-2013
06-01-2006
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
Specifies 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.
| Committee |
TC 170
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NEN EN 13503-5 : 2001 | Identical |
| I.S. EN 13503-5:2001 | Identical |
| NBN EN 13503-8 : 2000 | Identical |
| NS EN 13503-5 : 1ED 2001 | Identical |
| NBN EN 13503-5 : 2001 | Identical |
| BS EN 13503-5:2001 | Identical |
| NF EN 13503-5 : 2001 | Identical |
| DIN EN 13503-5:2001-07 | Identical |
| UNE-EN 13503-5:2001 | Identical |