Skip to content
Please enter a keyword to search

  • EN ISO 11608-2:2012

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)

    Available format(s): 

    Superseded date:  28-05-2022

    Language(s): 

    Published date:  01-04-2012

    Publisher:  Comite Europeen de Normalisation

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

    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)

    ISO 11608-2:2012 specifies 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)

    Committee CEN/TC 205
    Development Note Supersedes PREN ISO 11608-2. (04/2012)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    03/113382 DC : DRAFT SEP 2003 BS EN ISO 21649 - NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS

    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)
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective