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  • DIN EN ISO 11608-3:2013-01

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 3: Finished containers (ISO 11608-3:2012)

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-08-2022

    Language(s):  English, German

    Published date:  01-01-2013

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

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
      4.1 Freedom from leakage
      4.2 Initiating force
      4.3 Sustaining force
      4.4 Dimensions
      4.5 Eccentricity
      4.6 Visibility of the medicinal product
      4.7 Meniscus
      4.8 Resealability
      4.9 Cap
      4.10 Plunger and disc
      4.11 Material of the cylinder
      4.12 Lubrication
      4.13 Dose accuracy
      4.14 Deliverable volume and last-dose
           accuracy
    5 Test Methods
      5.1 Test apparatus
      5.2 Test conditions
      5.3 Test fluid
      5.4 Analytical approach
      5.5 Leakage (attribute)
      5.6 Forces required to initiate and
          sustain plunger movement (attribute)
      5.7 Dimensions (attribute)
      5.8 Eccentricity (attribute)
      5.9 Meniscus (attribute)
      5.10 Resealability (attribute)
      5.11 Dose accuracy (variable)
      5.12 Deliverable volume (attribute)
      5.13 Last-dose accuracy (variable)
    6 Information supplied by the manufacturer
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the functional and design considerations for containers to be used with needle-based injection systems (NIS) 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    Status Superseded
    Superseded By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 EN ISO 11608-2:2012-12 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)

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

    DIN EN ISO 7864:2015-01 (Draft) STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO 7864:2016)
    ISO 13926-1:2004 Pen systems Part 1: Glass cylinders for pen-injectors for medical use
    DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    DIN ISO 13926-1:2005-10 PEN SYSTEMS - PART 1: GLASS CYLINDERS FOR PEN-INJECTORS FOR MEDICAL USE
    ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
    ISO 11040-3:2012 Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
    DIN EN ISO 7886-1:2015-10 (Draft) STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
    ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    ISO 13926-2:2011 Pen systems Part 2: Plunger stoppers for pen-injectors for medical use
    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
    DIN EN ISO 8537:2008-10 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
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