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  • PD ISO/TR 22979:2017

    Current The latest, up-to-date edition.

    Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  21-09-2017

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Modifications to parent models
    5 Considerations for the assignment of modification
      level
    6 Modifications of optical design features
    7 Modifications to the mechanical design
    8 Modifications to material
    Annex A (informative) - Examples of modifications
            to a parent IOL model
    Annex B (informative) - Mechanical data analysis
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).

    Scope - (Show below) - (Hide below)

    This document provides guidance on the application of all parts of the ISO11979 series of International Standards for intraocular lenses (IOLs).[1-9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO14971 .[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.

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

    Committee CH/172/7
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    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 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
    ISO 11979-9:2006 Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
    ISO 11979-8:2017 Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 11979-4:2008 Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
    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
    ISO 11979-6:2014 Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing
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