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  • DIN EN ISO 11608-3 E : 2013

    Current The latest, up-to-date edition.

    NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS (ISO 11608-3:2012)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    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)

    National foreword
    National Annex NA (informative) - Bibliography
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Test methods
    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 Current

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

    DIN EN ISO 11608-2 E : 2012 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)

    ISO 13926-1:2004 Pen systems Part 1: Glass cylinders for pen-injectors for medical use
    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
    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 7886-1 E : 1997 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
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