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    I.S. EN ISO 11979-5:2020

    Current The latest, up-to-date edition.

    Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  26-10-2020

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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 (normative) Supplemental conditions of test for local effects after implantation
    Annex G (normative) Ocular implantation test
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them.

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

    Committee ISO/TC 172
    Document Type Standard
    Product Note The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.<br>
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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