Skip to content
Please enter a keyword to search

  • EN ISO 11979-8:2017

    Current The latest, up-to-date edition.

    Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)

    Available format(s): 

    Language(s): 

    Published date:  10-05-2017

    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
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Safety and performance
    5 Optical and mechanical properties
    6 Biocompatibility
    7 Clinical evaluation
    8 Manufacturing
    9 Sterilization
    10 Packaging and shelf-life
    11 Labelling and information
    12 Documentation
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 11979-8:2017 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

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

    Committee CEN/TC 170
    Development Note Supersedes EN 13503-8. (08/2006)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

    EN ISO 11979-5:2006 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
    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)
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    ISO 11979-10:2006 Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses
    ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
    ISO 14630:2012 Non-active surgical implants General requirements
    EN ISO 11979-3:2012 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)
    ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
    ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
    EN ISO 11979-2:2014 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
    ISO 11979-9:2006 Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
    EN ISO 11979-6:2014 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 11979-4:2008 Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    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 14971:2007 Medical devices Application of risk management to medical devices
    EN ISO 11979-9:2006/A1:2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
    ISO 11979-6:2014 Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
    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