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  • EN ISO 11979-3:2012

    Current The latest, up-to-date edition.

    Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)

    Available format(s): 

    Language(s): 

    Published date:  01-12-2012

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Recovery of properties following simulated surgical
      manipulation
    6 Additions for accommodating IOLs (AIOLs)
    Annex A (normative) - Measurement of compression force
    Annex B (normative) - Measurement of axial displacement
            in compression
    Annex C (normative) - Measurement of optic decentration
    Annex D (normative) - Measurement of optic tilt
    Annex E (normative) - Measurement of angle of contact
    Annex F (normative) - Testing of compression force decay
    Annex G (normative) - Testing of dynamic fatigue durability
    Annex H (informative) - Measurement of loop pull strength
    Annex I (informative) - Clearance analysis
    Annex J (informative) - Precision
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements and test methods for certain mechanical properties of intraocular lenses (IOLs).

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

    Committee CEN/TC 170
    Development Note Supersedes EN 13503-3. (05/2006)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
    I.S. EN ISO 11979-8:2017 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
    ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
    ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
    ISO 5725-4:1994 Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method
    ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
    ISO 5725:1986 Precision of test methods Determination of repeatability and reproducibility for a standard test method by inter-laboratory tests
    ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
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