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    I.S. EN ISO 5840-1:2021

    Current The latest, up-to-date edition.

    Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)

    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) Rationale for the provisions of ISO 5840-1
    Annex B (normative) Packaging
    Annex C (normative) Product labels, instructions for use, and training
    Annex D (normative) Sterilization
    Annex E (normative) In vitro test guidelines for paediatric devices
    Annex F (informative) Corrosion assessment
    Annex G (informative) Echocardiographic protocol
    Annex H (informative) Assessment of implant thrombogenic and haemolytic potential
    Annex I (informative) Guidelines for hydrodynamic performance characterization by steady flow testing
    Annex J (normative) Durability testing
    Annex K (informative) Fatigue assessment
    Annex L (normative) Clinical investigation endpoints for heart valve replacement devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document is applicable to heart valve substitutes intended for implantation and provides general requirements.

    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.<br>
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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