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  • PREN ISO 11979-6 : DRAFT 2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 6: SHELF-LIFE AND TRANSPORT STABILITY (ISO/DIS 11979-6:2013)

    Available format(s): 

    Superseded date:  01-10-2014

    Language(s): 

    Published date:  22-05-2013

    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 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)

    Defines tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined.

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

    Comment Closes On
    Committee TC 170
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    National Adoptions - (Show below) - (Hide below)

    Equivalent Standard(s) Relationship
    13/30254047 DC : 0 Identical

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

    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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