Skip to content
Please enter a keyword to search

  • 17/30336158 DC : 0

    NA Status of Standard is Unknown

    BS EN ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

    Add To Cart

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms, definitions and abbreviated terms
    4 Justification for a clinical investigation
    5 Ethical considerations
    6 General requirements
    Annex A (informative) - General elements in the
            clinical investigation of IOLs
    Annex B (informative) - Additional elements for the clinical
            investigation of toric IOLs
    Annex C (informative) - Additional elements for the clinical
            investigation of multifocal IOLs
    Annex D (informative) - Additional elements in the clinical
            investigation of accommodating IOLs
    Annex E (informative) - Evaluation of post-operative adverse events
            and visual acuity rates
    Annex F (informative) - Clinical tests
    Annex G (informative) - Statistical methods and sample size
            calculations
    Bibliography

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

    Comment Closes On
    Committee CH/172/7
    Document Type Draft
    Publisher British Standards Institution
    Status NA
    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