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  • ISO 11979-5:2006

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Ophthalmic implants Intraocular lenses Part 5: Biocompatibility

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  22-10-2020

    Language(s):  English, French

    Published date:  09-06-2006

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 11979-5:2006 specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.

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    Development Note Supersedes ISO/DIS 11979-5 (06/2006)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

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

    BIS IS/ISO 11979-8 : 2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
    ANSI Z80.27 : 2014 OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES
    ANSI Z80.13 : 2007 OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
    I.S. EN ISO 11979-10:2007 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES (ISO 11979-10:2018)
    ANSI Z80.7 : 2013 OPHTHALMIC OPTICS - INTRAOCULAR LENSES
    EN ISO 11979-10:2018 Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
    DIN EN ISO 11979-8 E : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
    BS EN ISO 10993-6:2016 Biological evaluation of medical devices Tests for local effects after implantation
    I.S. EN ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
    I.S. EN ISO 11979-8:2017 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
    05/30097406 DC : DRAFT JUL 2005 ISO 11979-6 - OPHTHALMIC INSTRUMENTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
    PD ISO/TR 22979:2017 Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
    ANSI Z80.29 : 2015 OPHTHALMICS - ACCOMODATIVE INTRAOCULAR LENSES
    ANSI/AAMI/ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
    17/30335550 DC : 0 BS EN ISO 11979-10 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES
    14/30261590 DC : 0 BS EN ISO 10993-6 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
    16/30337200 DC : 0 BS EN ISO 11979-8 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    ANSI Z80.13 : 2007 : R2017 OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
    ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
    ISO 11979-8:2017 Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
    DIN EN ISO 11979-8:2016-04 (Draft) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
    UNE-EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
    EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    ANSI Z80.30 : 2010 OPHTHALMICS - TORIC INTRAOCULAR LENSES
    ANSI Z80.13 : 2007 : R2012 OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
    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)

    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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