Skip to content
Please enter a keyword to search

  • NEN EN ISO 15798 : 2013 AMD 1 2017

    Current The latest, up-to-date edition.

    OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES

    Available format(s): 

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Netherlands Standards

    Sorry this product is not available in your region.

    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 to be supplied by the manufacturer
    Annex A (normative) - Intra-ocular implantation test
    Annex B (normative) - Test for intra-ocular pressure
    Annex C (informative) - Microscopic assay for particulate
                            matter
    Annex D (informative) - Patient numbers for clinical trials
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

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

    Document Type Standard
    Publisher Netherlands Standards
    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