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BS EN 13503-5:2001

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Ophthalmic implants. Intraocular lenses Biocompatibility
Available format(s)

Hardcopy , PDF

Superseded date

06-30-2006

Language(s)

English

Published date

05-15-2001

Publisher

British Standards Institution

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Superseded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

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
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

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PDF - English
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