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  • BS EN ISO 11979-3:2012

    Current The latest, up-to-date edition.

    Ophthalmic implants. Intraocular lenses Mechanical properties and test methods

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-12-2012

    Publisher:  British Standards Institution

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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).

    Scope - (Show below) - (Hide below)

    This part of ISO11979 specifies requirements and test methods for certain mechanical properties of intraocular lenses (IOLs).

    It is applicable to all types of IOLs intended for implantation in the anterior segment of the human eye, excluding corneal implants, provided that the test method is appropriate to the particular IOL design.

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

    Committee CH/172/7
    Development Note Supersedes BS EN 13503-3 & 04/30103818 DC (05/2006) Supersedes 11/30218023 DC. (12/2012)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    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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