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  • DIN EN ISO 11979-6:2015-02

    Current The latest, up-to-date edition.

    Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)

    Available format(s):  Hardcopy, PDF

    Language(s):  English, German

    Published date:  01-02-2015

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Development Note Supersedes DIN EN 13503-6. (11/2007)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current
    Supersedes

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

    DIN EN ISO 11979-1:2013-01 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012)
    DIN EN ISO 11979-5:2010-11 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
    DIN EN ISO 11979-3:2013-04 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
    DIN EN ISO 11979-4:2013-01 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
    DIN EN ISO 11979-8:2016-04 (Draft) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)

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

    DIN EN ISO 11607-1:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
    DIN EN ISO 11979-3:2013-04 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
    DIN EN ISO 11979-1:2013-01 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012)
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    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 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    DIN EN ISO 11979-10:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014)
    DIN EN ISO 11979-4:2013-01 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
    DIN EN ISO 11979-2:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014)
    DIN EN ISO 11979-5:2010-11 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
    DIN EN ISO 10993-5:2009-10 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
    ASTM F 1929 : 2015 : REDLINE Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
    ISO 2233:2000 Packaging Complete, filled transport packages and unit loads Conditioning for testing
    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 10993-12:2012-10 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    DIN EN ISO 11607-2:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014)
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    DIN EN ISO 11979-8:2016-04 (Draft) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
    DIN EN ISO 11979-7:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
    ISO 8318:2000 Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency
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