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  • 10/30212297 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-04-2012

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Dimensions and designation
    4 Requirements
    5 Tolerance on graduated capacity
    6 Packaging and labelling
    Annex A (informative) - Head designs
    Annex B (informative) - Guidance on materials
    Annex C (informative) - Test for the determination
            of particulate contamination
    Bibliography

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

    Comment Closes On
    Committee CH/212
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 11040-7:2015 Prefilled syringes Part 7: Packaging systems for sterilized subassembled syringes ready for filling
    ASTM D 7210 : 2013 : REDLINE Standard Practice for Extraction of Additives in Polyolefin Plastics
    ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    ISO 13926-2:2011 Pen systems Part 2: Plunger stoppers for pen-injectors for medical use
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ISO 15747:2010 Plastic containers for intravenous injections
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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