• EN ISO 11979-6:2014

    Current The latest, up-to-date edition.

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

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    Published date:  15-10-2014

    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 Requirements
    5 Test methods and sampling
    Annex A (informative) - Shelf-life study example
    Annex B (informative) - Tests for shelf-life studies
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 11979-6:2014 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.

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

    Committee CEN/TC 170
    Development Note Supersedes EN 13503-6. (09/2007) Supersedes PREN ISO 11979-6. (10/2014)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

    EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
    I.S. EN ISO 11979-8:2017 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)

    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
    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
    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
    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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