• NEN EN ISO 11979-9 : 2006 AMD 1 2014

    Current The latest, up-to-date edition.

    OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES

    Available format(s): 

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Netherlands Standards

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Physical requirements
      4.1 General
      4.2 Tolerances and dimensions
    5 Optical requirements
      5.1 General
      5.2 Dioptric power
      5.3 Imaging quality
      5.4 Additional optical characterization
    6 Clinical investigation
      6.1 General
      6.2 Additional requirements for the clinical
          investigation plan
    7 Information supplied by the manufacturer
    Annex A (normative) Optical characterization
    Annex B (informative) Clinical investigation
    Annex C (informative) Determination of sample sizes
            for the clinical investigation
    Bibliography

    Abstract - (Show below) - (Hide below)

    Applies to any intraocular lens whose optic provides two or more rotationally symmetric powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near).

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    Document Type Standard
    Publisher Netherlands Standards
    Status Current
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