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    I.S. EN ISO 11608-2:2012

    Current The latest, up-to-date edition.

    NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2012

    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 Requirements
    5 Sampling
    6 Pre-conditioning of needles
    7 Standard atmosphere and apparatus for tests
    8 Determination of dislocation of measuring point at
       patient end
    9 Bond between hub and needle tube
    10 Packaging
    11 Test method for validating the compatibility of needles
       and injector systems
    12 Information supplied by the manufacturer
    Annex A (normative) - Determination of flow rate through
            needle
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.

    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 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO/IEC Guide 98-1:2009 Uncertainty of measurement — Part 1: Introduction to the expression of uncertainty in measurement
    ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
    ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels
    IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)
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