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    I.S. EN ISO 80369-7:2021

    Current The latest, up-to-date edition.

    Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  16-06-2021

    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 General requirements
    5 Dimensional requirements for Luer connectors
    6 Performance requirements
    Annex A (informative) Rationale and guidance
    Annex B (normative) Luer connectors
    Annex C (normative) Reference connectors
    Annex D (informative) Assessment of medical devices and their attributes with connections within this application
    Annex E (informative) Summary of the usability requirements for Luer connectors for intravascular or hypodermic applications
    Annex F (informative) Summary of Luer connector design requirements for intravascular or hypodermic applications
    Annex G (informative) Summary of assessment of the design of the Luer connector for intravascular or hypodermic applications
    Annex H (informative) Reference to the essential principles
    Annex I (informative) Reference to the general safety and performance requirements
    Annex J (informative) Terminology — Alphabetized index of defined terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.

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

    Committee TC 210
    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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