Skip to content
Please enter a keyword to search

  • EN 13503-6 : 2002

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY

    Available format(s): 

    Withdrawn date:  30-06-2007

    Language(s): 

    Published date:  12-11-2002

    Publisher:  Comite Europeen de Normalisation

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

    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    Status Withdrawn

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

    I.S. EN 13503-8:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    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
    BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses 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    ASTM F 1585 : 2000 Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006)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 10993-9:2009 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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective