Skip to content
Please enter a keyword to search
  • Preview

    I.S. EN ISO 16672:2021

    Current The latest, up-to-date edition.

    Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-10-2021

    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.

    Add To Cart

    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 Integrity and performance of the delivery system
    10 Packaging
    11 Information supplied by the manufacturer
    Annex A (normative) Intraocular implantation test
    Annex B (informative) Clinical investigation
    Annex C (informative) Method for quantifying incompletely fluorinated contaminants in perfluorocarbon liquids
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.

    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
    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