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  • BS EN ISO 11499:2014

    Current The latest, up-to-date edition.

    Dentistry. Single-use cartridges for local anaesthetics

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-06-2014

    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 Marking
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides specific performance requirements for single-use dental cartridges of 1,0 ml, 1,7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics.

    Scope - (Show below) - (Hide below)

    This International Standard gives specific performance requirements for single-use dental cartridges of 1,0ml, 1,7ml, 1,8ml and 2,2ml nominal capacity for use with local anaesthetics.

    It specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall dimensions to ensure that the cartridge will fit dental cartridge syringes complying with ISO9997 and ISO21533.

    Labelling requirements are also specified.

    NOTE A list of International Standards for certain types of cartridge component is given in the Bibliography.

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

    Committee CH/106/4
    Development Note Renumbers and supersedes BS ISO 11499. 1999 version incorporates amendment 10696 to BS ISO 11499. Supersedes 95/561272 DC. (11/2005) Supersedes 06/30109922 DC. (08/2007) Supersedes 13/30257549 DC. (06/2014)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 11040-2:2011 Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges
    ISO 7885:2010 Dentistry Sterile injection needles for single use
    ISO 21533:2003 Dentistry Reusable cartridge syringes intended for intraligamentary injections
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    ISO 11040-3:2012 Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
    ISO 9997:1999 Dental cartridge syringes
    ISO 1942:2009 Dentistry Vocabulary
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 7500-1:2015 Metallic materials Calibration and verification of static uniaxial testing machines Part 1: Tension/compression testing machines Calibration and verification of the force-measuring system
    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 11040-1:2015 Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges
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