BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
06-30-2006
English
05-15-2001
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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
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 |
CH/172/7
|
| DevelopmentNote |
Supersedes 97/565187 DC. (09/2005)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN EN 13503-5 : 2001 | Identical |
| EN 13503-5 : 2001 | Identical |
| I.S. EN 13503-5:2001 | Identical |
| SN EN 13503-5 : 2001 | Identical |
| UNI EN 13503-5 : 2001 | Identical |
| NS EN 13503-5 : 1ED 2001 | Identical |
| NBN EN 13503-5 : 2001 | Identical |
| NF EN 13503-5 : 2001 | Identical |
| UNE-EN 13503-5:2001 | Identical |
| DIN EN 13503-5:2001-07 | Identical |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| EN ISO 10993-2:2006 | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006) |
| EN ISO 10993-11:2009 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
| EN 1441 : 1997 | MEDICAL DEVICES - RISK ANALYSIS |
| EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| EN ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
| EN 30993-6 : 1994 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
| EN ISO 11979-2:2014 | Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014) |
| ISO 11979-1:2006 | Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
| EN ISO 10993-12:2012 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| EN 13503-3 : 2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS |
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