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  • DIN EN ISO 11608-2:2012-12

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - Part 2: Needles (ISO 11608-2:2012)

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-08-2022

    Language(s):  English, German

    Published date:  01-12-2012

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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    Table of Contents - (Show below) - (Hide below)

    Contents
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    4.1 Colour coding
    4.2 Materials
    4.3 Dimensions
    4.4 Patency of lumen
    4.5 Needle points
    4.6 Freedom from defects
    4.7 Lubrication
    4.8 Dislocation of measuring point at the patient-
        end of type A needles
    4.9 Bond between hub and needle tube
    4.10 Unscrewing torque of the needle
    4.11 Ease of assembly/disassembly
    4.12 Sterility
    5 Sampling
    6 Preconditioning of needles
    6.1 Preconditioning in dry heat atmosphere
    6.2 Preconditioning in cold storage atmosphere
    6.3 Preconditioning in cyclical atmosphere
    7 Standard atmosphere and apparatus for tests
    7.1 Standard test atmosphere
    7.2 Test apparatus
    8 Determination of dislocation of measuring point
        at the patient-end of Type A needles
    9 Bond between hub and needle tube
    10 Unscrewing torque of the needle
    11 Packaging
    12 Information supplied by the manufacturer
    12.1 General
    12.2 Marking
    12.3 Instructions for use
    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 German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    DIN EN ISO 11608-4:2016-03 (Draft) PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
    DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)

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

    DIN ISO 7000:2008-12 Graphical symbols for use on equipment - Index and synopsis (ISO 7000:2004 + ISO 7000 Database:2008 up to ISO 7000-2750)
    DIN EN ISO 7864:2015-01 (Draft) STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO 7864:2016)
    DIN EN ISO 11608-3:2013-01 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
    DIN EN ISO 11608-1:2015-04 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
    ISO 15510:2014 Stainless steels Chemical composition
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    DIN ISO 2859-1:2014-08 SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES - PART 1: SAMPLING SCHEMES INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION (ISO 2859-1:1999 + COR. 1:2001 + AMD.1:2011)
    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
    DIN EN 60068-2-30:2006-06 ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE)
    ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
    DIN EN ISO 9626:2015-03 (Draft) STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS (ISO 9626:2016)
    DIN EN ISO 9000:2015-11 QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
    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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