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  • UNI EN ISO 11979-10 : 2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES

    Available format(s): 

    Superseded date:  15-03-2019

    Language(s): 

    Published date:  31-12-2014

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Optical requirements
    5 Mechanical requirements
    6 Clinical investigation
    7 Information supplied by the manufacturer
    Annex A (informative) - Clinical investigation
    Annex B (informative) - Statistical sample size
            considerations
    Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye.

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

    Committee U42.00.06
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 11979-4:2008 Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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