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  • BS EN ISO 11979-5:2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  12-10-2020

    Language(s):  English

    Published date:  30-06-2006

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements applying to biocompatibility
      evaluation of intraocular lenses
    5 Physicochemical tests
    6 Biological tests
    Annex A (normative) Exhaustive extraction test
    Annex B (normative) Test for leachables
    Annex C (normative) Hydrolytic stability
    Annex D (normative) Photostability test
    Annex E (normative) Nd-YAG laser exposure test
    Annex F (informative) Supplemental conditions of test for
                          local effects after implantation
    Annex G (normative) Ocular implantation test
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. It also gives guidance on conducting an ocular implantation test.

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

    Committee CH/172/7
    Development Note Supersedes BS EN 13503-5 & 04/30103836 DC (06/2006)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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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