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    I.S. EN ISO 16671:2015&A1:2017

    Current The latest, up-to-date edition.

    Ophthalmic implants - Irrigating solutions for ophthalmic surgery

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  10-12-2017

    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
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Intended performance
    5 Design attributes
    6 Design evaluation
    7 Sterilization
    8 Product stability
    9 Packaging
    10 Information supplied by the manufacturer
    Annex A (informative) Example of a suitable method for pH measurement and buffer capacity determination
    Annex B (normative) Particulate contamination: Visible particulates
    Annex C (informative) Light obscuration test method for particulate contamination: subvisible particles
    Annex D (informative) Microscopic test method for particulate contamination: subvisible particles
    Annex E (normative) Intraocular irrigation test
    Annex F (informative) Clinical investigation
    Bibliography

    Abstract - (Show below) - (Hide below)

    This International Standard defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.

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

    Committee ISO/TC 172
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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