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    I.S. EN ISO 9626:2016

    Current The latest, up-to-date edition.

    STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2016

    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)

    National Foreword
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Materials
    5 Requirements
    Annex A (normative) - Methods for preparation
            of extracts
    Annex B (normative) - Test method for stiffness
            of tubing
    Annex C (normative) - Test method for resistance
            of tubing to breakage
    Annex D (normative) - Test method for resistance
            to corrosion
    Annex E (informative) - Rationale with respect to
            test method for stiffness of tubing
    Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

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

    ISO 15510:2014 Stainless steels Chemical composition
    ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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