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  • ISO 11979-4:2008

    Current The latest, up-to-date edition.

    Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information

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

    Language(s): 

    Published date:  17-11-2008

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 11979-4:2008 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.

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

    Development Note Supersedes ISO/DIS 11979-4. (11/2008)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    12/30218026 DC : 0 BS EN ISO 11979-2 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS
    BIS IS/ISO 11979-8 : 2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    BS EN ISO 11979-9 : 2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
    BS EN ISO 11979-2:2014 Ophthalmic implants. Intraocular lenses Optical properties and test methods
    EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
    EN 13503-6 : 2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
    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 11979-9 E : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
    I.S. EN ISO 11979-2:2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014)
    I.S. EN ISO 11979-8:2017 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
    05/30097406 DC : DRAFT JUL 2005 ISO 11979-6 - OPHTHALMIC INSTRUMENTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
    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
    PD ISO/TR 22979:2017 Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
    DIN EN ISO 11979-2:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014)
    EN ISO 11979-9:2006/A1:2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
    UNI EN ISO 11979-2 : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS
    UNI EN ISO 11979-9 : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
    BS EN ISO 11979-10 : 2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES
    UNI EN ISO 11979-10 : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES
    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
    ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
    DIN EN ISO 11979-2 E : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014)
    ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
    ISO 11979-8:2017 Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
    DIN EN ISO 11979-8:2016-04 (Draft) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
    I.S. EN ISO 11979-9:2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
    UNE-EN ISO 11979-2:2015 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
    UNE-EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
    EN ISO 11979-2:2014 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
    ONORM EN ISO 11979-10 : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD 1:2014)
    DIN EN ISO 11979-10:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014)
    ANSI Z80.12 : 2007 : R2017 OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES
    ANSI Z80.12 : 2007 OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES
    BS EN 13503-6:2002 Ophthalmic implants. Intraocular lenses Shelf-life and transport stability

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

    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 980:2008 Symbols for use in the labelling of medical devices
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