Skip to content
Please enter a keyword to search

  • BS EN ISO 11979-7:2014

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    Ophthalmic implants. Intraocular lenses Clinical investigations

    Available format(s):  Hardcopy, PDF

    Superseded date:  05-06-2018

    Language(s):  English

    Published date:  30-09-2014

    Publisher:  British Standards Institution

    Add To Cart

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Justification for a clinical investigation
    5 Ethical considerations
    6 General requirements
    Annex A (informative) - Elements of a clinical
            investigation
    Annex B (informative) - Evaluation of post-operative
            adverse event and visual acuity rates
    Annex C (informative) - Additional elements for toric
            IOLs
    Annex D (informative) - Additional elements for
            accommodating IOLs
    Annex E (informative) - Clinical tests
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines particular requirements for clinical investigations for posterior and anterior chamber intraocular lenses (IOLs).

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

    Committee CH/172/7
    Development Note Supersedes BS EN 13503-7 and 04/30103843 DC. (05/2006) Supersedes 12/30218032 DC. (09/2014)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 11979-10:2006 Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses
    ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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