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  • BS EN ISO 11608-2:2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Needle-based injection systems for medical use. Requirements and test methods Needles

    Available format(s):  Hardcopy, PDF

    Superseded date:  15-07-2022

    Language(s):  English

    Published date:  30-04-2012

    Publisher:  British Standards Institution

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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.

    Scope - (Show below) - (Hide below)

    This part of ISO11608 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO11608-1.

    It is not applicable to:

    • needles for dental use;

    • pre-filled syringe needles;

    • needles pre-assembled by the manufacturer;

    • needles not requiring assembly or attachment to the NIS.

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

    Committee CH/84
    Development Note Supersedes 97/563388 DC (03/2005) Supersedes 10/30209603 DC. (04/2012)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    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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