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  • EN 13503-6 : 2002

    Cancelled Standard has been cancelled.
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    OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY

    Available format(s): 

    Cancelled date:  01-07-2007

    Language(s): 

    Published date:  13-11-2002

    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 (normative) Shelf-life and transport stability
            test table
    Annex B (informative) Test method for the determination
            of extractable substances
    Annex C (informative) References relating to tests to be
            performed during shelf-life studies
    Annex D (informative) Selected definitions
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests included procedures to establish the stability of IOLs in distribution and storage.

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

    Committee TC 170
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Cancelled

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

    I.S. EN 13503-8:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    BS EN 13503-8 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    DIN EN 13503-6:2003-03 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
    EN 13503-8 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS

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

    ASTM F 1585 : 2000 Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006)
    ASTM D 4169 : 2016 : REDLINE Standard Practice for Performance Testing of Shipping Containers and Systems
    EN ISO 11979-1 : 2012 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012)
    EN ISO 11979-4:2008/A1:2012 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008/AMD 1:2012)
    ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
    EN ISO 10993-9 : DEC 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS (ISO 10993-9:2009)
    ISO 10339:1997 Ophthalmic optics Contact lenses Determination of water content of hydrogel lenses
    ASTM F 1929 : 2015 : REDLINE Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
    ISO 11979-3:2012 Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods
    EN 22248 : 1992 COMPLETE, FILLED TRANSPORT PACKAGES - METHOD FOR DETERMINATION OF RESISTANCE TO VERTICAL IMPACT BY DROPPING (ISO 2248:1985)
    EN ISO 11979-2 : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014)
    AAMI TIR22 : 2007 GUIDANCE FOR ANSI/AAMI/ISO 11607, PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1 AND PART 2:2006
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    EN ISO 10339 : 1999 OPHTHALMIC OPTICS - CONTACT LENSES - DETERMINATION OF WATER CONTENT OF HYDROGEL LENSES
    ISO 11979-4:2008 Ophthalmic implants Intraocular lenses Part 4: Labelling and information
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 3696:1987 Water for analytical laboratory use Specification and test methods
    EN ISO 3696 : 1995 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS (ISO 3696:1987)
    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 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
    EN 13503-3 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
    EN 13503-5 : 2001 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY
    EN ISO 8318 : 2002 PACKAGING - COMPLETE, FILLED TRANSPORT PACKAGES AND UNIT LOADS - SINUSOIDAL VIBRATION TESTS USING A VARIABLE FREQUENCY
    EN 13503-7 : 2001 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
    ISO 8318:2000 Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency
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