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  • BS EN ISO 11979-9 : 2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 9: MULTIFOCAL INTRAOCULAR LENSES

    Available format(s):  Hardcopy, PDF

    Superseded date:  05-06-2018

    Language(s):  English

    Published date:  01-01-2006

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Physical requirements
    5 Optical requirements
    6 Clinical investigation
    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)

    Define to any intraocular lens whose optic provides two or more 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).

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

    Committee CH/172
    Development Note 2006 Edition Re-issued in September 2014 & incorporates AMD 1 2014. Supersedes 13/30280910 DC. (09/2014)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By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/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 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 14971:2007 Medical devices Application of risk management to medical devices
    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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