• UNE-EN ISO 11608-3:2013

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-07-2022

    Language(s):  Spanish, Castilian, English

    Published date:  20-03-2013

    Publisher:  Asociacion Espanola de Normalizacion

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    Abstract - (Show below) - (Hide below)

    Questo Standard definisce metodi di prestazioni e test per multidose Single-chamber, si preriempito, finito cartucce impiegate come primario Contenitori in dispositivi a iniezione di penna. La progettazione e le dimensioni sono specificate Per cartucce di Tipo A. Questo Standard non è applicabile a Cartucce di multicamera, cartucce che sono riempite dall'utente E le cartucce hanno destinato a uso dentale.

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    Committee CTN 111
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Superseded
    Superseded By
    Supersedes

    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
    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
    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
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