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  • BS 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Finished containers

    Available format(s):  Hardcopy, PDF

    Superseded date:  10-11-2022

    Language(s):  English

    Published date:  31-10-2012

    Publisher:  British Standards Institution

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

    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.

    Scope - (Show below) - (Hide below)

    This part of ISO11608 specifies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO11608-1. 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 end-user integrated in the NIS or assembled with the NIS at the time of use.

    This part of ISO11608 includes specifications and test methods to describe and evaluate cartridges for use in NIS with pen needles (as defined in ISO11608-2) and outlines design considerations for other potential containers, including syringes to be used with a NIS.

    This part of ISO11608 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 ISO11608.

    NOTE See ISO7864 (needles), ISO8537 (insulin syringes) and ISO7886-1 (manual syringes).

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

    Committee CH/84
    Development Note Supersedes 97/563389 DC. (03/2005) Supersedes 10/30208782 DC. (10/2012)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By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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