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  • PD ISO/TR 19244:2014

    Current The latest, up-to-date edition.

    Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-08-2014

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Recommendations for implementing
      ISO/TC 84 standards
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the recommended transition plans for all the TC 84 standards: - Needle-based Injection systems [ISO 11608 (all parts)]; - Sharps Injury Protection (ISO 23908); - Sharps Containers (ISO 23907), - Aerosol Drug Delivery Devices (ISO 20072); - Needle-free injection systems (ISO 21649); - Syringes [ISO 7886 (all parts), ISO 8537, ISO 9626]; - Needles (ISO 6009, ISO 7864); and - Intravascular Catheters and Ports [ISO 10555 (all parts), ISO 11070].

    Scope - (Show below) - (Hide below)

    This Technical Report outlines the recommended transition plans for all the TC84 standards:

    • Needle-based Injection systems [ISO11608 (all parts)];

    • Sharps Injury Protection (ISO23908);

    • Sharps Containers (ISO23907),

    • Aerosol Drug Delivery Devices (ISO20072);

    • Needle-free injection systems (ISO21649);

    • Syringes [ISO7886 (all parts), ISO8537, ISO9626];

    • Needles (ISO6009, ISO7864);

    • Intravascular Catheters and Ports [ISO10555 (all parts), ISO11070].

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

    Committee CH/84
    Document Type Standard
    Publisher British Standards Institution
    Status Current

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

    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    ISO 20072:2009 Aerosol drug delivery device design verification Requirements and test methods
    ISO 21649:2006 Needle-free injectors for medical use — Requirements and test methods
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 23907:2012 Sharps injury protection Requirements and test methods Sharps containers
    ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
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