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  • ISO/TR 22979:2017

    Current The latest, up-to-date edition.

    Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  27-04-2017

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.

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

    Document Type Technical Report
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    11/30218023 DC : 0 BS EN ISO 11979-3 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
    12/30218032 DC : 0 BS EN ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
    BS EN ISO 11979-9 : 2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
    EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
    EN ISO 11979-3:2012 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)
    04/30103818 DC : DRAFT JUL 2004 ISO 11979-3 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
    BS EN ISO 11979-7:2014 Ophthalmic implants. Intraocular lenses Clinical investigations
    DIN EN ISO 11979-7:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
    EN ISO 11979-10:2018 Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
    DIN EN ISO 11979-9:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
    DIN EN ISO 11979-8 E : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
    DIN EN ISO 11979-7 E : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
    DIN EN ISO 11979-9 E : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
    DIN EN ISO 11979-6 E : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
    DIN EN ISO 11979-3:2013-04 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
    I.S. EN ISO 11979-8:2017 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
    I.S. EN ISO 11979-6:2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
    I.S. EN ISO 11979-3:2012 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
    UNI EN ISO 11979-6 : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING
    17/30335550 DC : 0 BS EN ISO 11979-10 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES
    17/30336158 DC : 0 BS EN ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA
    ISO 11979-10:2018 Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
    PREN ISO 11979-6 : DRAFT 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY (ISO/DIS 11979-6:2013)
    DIN EN ISO 11979-6:2015-02 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
    EN ISO 11979-9:2006/A1:2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
    UNI EN ISO 11979-9 : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
    UNI EN ISO 11979-3 : 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
    13/30254047 DC : 0 BS EN ISO 11979-6 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
    UNI EN ISO 11979-7 : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
    I.S. EN ISO 11979-7:2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA (ISO 11979-7:2018)
    I.S. EN ISO 11979-10:2007 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES (ISO 11979-10:2018)
    16/30337200 DC : 0 BS EN ISO 11979-8 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    EN ISO 11979-7:2018 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)
    DIN EN ISO 11979-3 E : 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
    ISO 11979-9:2006 Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
    BS EN ISO 11979-6:2014 Ophthalmic implants. Intraocular lenses Shelf-life and transport stability testing
    ISO 11979-6:2014 Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing
    UNE-EN ISO 11979-7:2015 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014)
    ISO 11979-8:2017 Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
    UNE-EN ISO 11979-3:2013 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)
    DIN EN ISO 11979-8:2016-04 (Draft) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
    BS EN ISO 11979-3:2012 Ophthalmic implants. Intraocular lenses Mechanical properties and test methods
    I.S. EN ISO 11979-9:2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
    UNE-EN ISO 11979-6:2015 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
    ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
    UNE-EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
    EN ISO 11979-6:2014 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
    04/30103843 DC : DRAFT JUL 2004 ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS

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

    ISO 11979-10:2006 Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses
    ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
    ISO 11979-9:2006 Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
    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 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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