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  • 17/30335550 DC : 0

    NA Status of Standard is Unknown

    BS EN ISO 11979-10 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms, definitions and abbreviated terms
    4 Optical requirements
    5 Mechanical requirements
    6 Biocompatibility requirements
    7 Shelf-life and transport stability requirements
    8 Fundamental requirements
    9 Justification for a clinical investigation
    10 General clinical requirements
    11 Information supplied by the manufacturer
    Annex A (informative) - Elements in a phakic
            IOL clinical investigation
    Annex B (informative) - Statistical methods
            and sample size calculations
    Bibliography

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

    Comment Closes On
    Committee CH/172/7
    Document Type Draft
    Publisher British Standards Institution
    Status NA

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

    ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
    ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
    ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
    ISO 11979-8:2017 Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
    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
    ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11979-6:2014 Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing
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