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    I.S. EN ISO 5840-3:2021

    Current The latest, up-to-date edition.

    Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  21-02-2021

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Abbreviations
    5 Fundamental requirements
    6 Device description
    7 Design verification and validation
    Annex A (informative) Description of the transcatheter heart valve system
    Annex B (informative) Transcatheter heart valve substitute hazard analysis example
    Annex C (informative) Guidelines for verification of hydrodynamic performance —
    Annex D (normative) Requirements for delivery system design and evaluation
    Annex E (informative) Examples of design specific testing
    Annex F (informative) Preclinical in vivo evaluation
    Annex G (normative) Adverse event classification during clinical investigation
    Annex H (informative) Multimodality imaging of TAVI and TMVI pre, peri and postimplantation
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute.

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

    Committee TC 150
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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