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  • BS ISO 18189:2016

    Current The latest, up-to-date edition.

    Ophthalmic optics. Contact lenses and contact lens care products. Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-06-2016

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principle
    5 Direct contact cytotoxicity test for lens/lens care
      solution combination
    6 Assessment of results
    7 Test report
    Annex A (normative) - Measurement of zone of cell lysis
            for the direct contact cytotoxicity test method for testing
            contact lens in combination with lens care solution
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies an in vitro test method to assess the potential cytotoxic effects that may arise due to interaction of contact lenses with contact lens care solutions.

    Scope - (Show below) - (Hide below)

    This International Standard describes an in vitro test method to assess the potential cytotoxic effects that may arise due to interaction of contact lenses with contact lens care solutions.

    NOTE The potential of a contact lens or a contact lens care solution to cause cytotoxicity by itself can be evaluated in accordance with general guidance in ISO10993-5.

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

    Committee CH/172/9
    Development Note Supersedes 15/30266276 DC. (06/2016)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 18369-1:2017 Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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