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  • ONORM EN ISO 11608-3 : 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 3: FINISHED CONTAINERS (ISO 11608-3:2012)

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    Superseded date:  27-10-2022

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Osterreichisches Normungsinstitut/Austrian Standards

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    Abstract - (Show below) - (Hide below)

    Diese Norm legt Bauart, Gesamtmasse, Leistung und Prüfverfahren für Einkammer-Mehrfachdosierungskarpulen fest, die als Fertigkarpulen mit einer pharmazeutischen Substanz gefüllt sind und als Primärbehälter in Pen-Injektoren dienen.

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    Committee TC 179
    Document Type Standard
    Publisher Osterreichisches Normungsinstitut/Austrian Standards
    Status Superseded
    Superseded By

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

    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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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