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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN ISO 9394 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-10-2012

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 General requirements
    4 Animals and husbandry
    5 Reagents/Materials
    6 Apparatus
    7 Test specimens
    8 Test procedure
    9 Assessment of results
    10 Test report
    Annex A (normative) - McDonald-Shadduck score
            system - Slit lamp
    Annex B (normative) - Draize scale for scoring
            ocular lesions
    Bibliography

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

    Comment Closes On
    Committee CH/172/9
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    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 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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