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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Superseded date:  01-06-2006

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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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 TC 170
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    I.S. EN 13503-8:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    EN 13503-8 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    DIN EN 13503-6:2003-03 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
    I.S. EN 13503-6:2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
    BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses Fundamental requirements
    BS EN 13503-6:2002 Ophthalmic implants. Intraocular lenses Shelf-life and transport stability
    EN 13503-6 : 2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY

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

    EN ISO 11979-1:2012 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)
    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
    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)
    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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