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  • EN 13503-7 : 2001

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 7: CLINICAL INVESTIGATIONS

    Available format(s): 

    Superseded date:  01-05-2006

    Language(s): 

    Published date:  12-01-2013

    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 General requirements
    5 Methodology
       5.1 General
       5.2 Requirements before commencement of the clinical
            investigation
       5.3 Clinical investigation plan
       5.4 Role of sponsor
       5.5 Role of monitor
       5.6 Role of clinical investigator
    6 Presentation of results
    Annex A (normative) Selected definitions
    Annex C (informative) Elements of an IOL clinical protocol
    Annex D (informative) Post-operative adverse event and
             visual acuity rates associated with historical
             IOL control populations
    Annex ZA (informative) A-Deviations
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes particular requirements for clinical investigation protocols for posterior and anterior chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.

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

    Committee TC 170
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    I.S. EN 13503-8:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    EN 13503-8 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    EN 13503-3 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
    I.S. EN 13503-3:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
    DIN EN 13503-6:2003-03 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
    I.S. EN 13503-6:2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
    BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses Fundamental requirements
    BS EN 13503-6:2002 Ophthalmic implants. Intraocular lenses Shelf-life and transport stability
    EN 13503-6 : 2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY

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

    EN ISO 11979-1:2012 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)
    EN 540 : 1993 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
    ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
    EN ISO 11979-2:2014 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    EN ISO 8597 : 1996 OPTICS AND OPTICAL INSTRUMENTS - VISUAL ACUITY TESTING - METHOD OF CORRELATING OPTOTYPES
    EN 13503-3 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
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