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  • BS EN 13503-5:2001

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Ophthalmic implants. Intraocular lenses Biocompatibility

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-06-2006

    Language(s):  English

    Published date:  15-05-2001

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CH/172/7
    Development Note Supersedes 97/565187 DC. (09/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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