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  • ISO 11608-3:2012

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  07-04-2022

    Language(s):  English, French

    Published date:  20-09-2012

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    This part of ISO 11608 specifies the functional and design considerations for containers to be used with

    needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and

    multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser

    integrated in the NIS or assembled with the NIS at the time of use.

    This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use

    in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential

    containers, including syringes to be used with a NIS.

    This part of ISO 11608 is not applicable to cartridges intended for dental use.

    Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this

    part of ISO 11608.

    NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 11608-3. (09/2012)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

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

    ISO 11040-8:2016 Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
    BS ISO 13926-3:2012 Pen systems Seals for pen-injectors for medical use
    10/30218554 DC : 0 BS ISO 13926-3 - PEN SYSTEMS - PART 3: SEALS FOR PEN-INJECTORS FOR MEDICAL USE
    UNE-EN ISO 11608-5:2013 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
    DIN EN ISO 11608-5:2013-01 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
    BS ISO 13926-2:2017 Pen systems Plunger stoppers for pen-injectors for medical use
    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
    I.S. EN ISO 11608-2:2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012)
    PREN ISO 11608-2 : DRAFT 2010 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
    BS EN ISO 11608-5:2012 Needle-based injection systems for medical use. Requirements and test methods Automated functions
    10/30208977 DC : 0 BS EN ISO 11608-1 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
    UNI EN ISO 11608-5 : 2013 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS
    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)
    UNI EN ISO 11608-2 : 2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
    I.S. EN ISO 11608-4:2007 PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
    17/30353012 DC : 0 BS ISO 13926-2 - PEN SYSTEMS - PART 2: PLUNGER STOPPERS FOR PEN-INJECTORS FOR MEDICAL USE
    15/30304642 DC : 0 BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
    10/30209603 DC : 0 BS EN ISO 11608-2 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
    I.S. EN ISO 11608-5:2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012)
    ISO 13926-2:2017 Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use
    BS EN ISO 11608-2:2012 Needle-based injection systems for medical use. Requirements and test methods Needles
    BS EN ISO 11608-4:2007 Pen-injectors for medical use Requirements and test methods for electronic and electromechanical pen-injectors
    ISO 11608-4:2006 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)
    ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
    EN ISO 11608-2:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
    EN ISO 11608-5:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
    EN ISO 11608-4:2007 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
    10/30213842 DC : 0 BS EN ISO 11608-5 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS
    PREN ISO 11608-1 : DRAFT 2010 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
    ISO 13926-3:2012 Pen systems Part 3: Seals for pen-injectors for medical use
    ISO 11608-5:2012 Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions
    DIN ISO 13926-2:2012-09 PEN SYSTEMS - PART 2: PLUNGER STOPPERS FOR PEN-INJECTORS FOR MEDICAL USE (ISO 13926-2:2011)

    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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