Skip to content
Please enter a keyword to search

  • UNI EN ISO 9394 : 2013

    Current The latest, up-to-date edition.

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

    Available format(s): 

    Language(s): 

    Published date:  06-02-2013

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

    Sorry this product is not available in your region.

    Add To Cart

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

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

    Abstract - (Show below) - (Hide below)

    Describes an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products.

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

    Committee CT 44
    Document Type Test Method
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    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 10993-2:2006 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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective