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  • EN ISO 11499:2014

    Current The latest, up-to-date edition.

    Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)

    Available format(s): 

    Language(s): 

    Published date:  04-06-2014

    Publisher:  Comite Europeen de Normalisation

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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)

    ISO 11499:2014 gives 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.ISO 11499:2014 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. Labelling requirements are also specified.

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

    Committee CEN/TC 55
    Development Note Supersedes PREN ISO 11499. (06/2014)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

    02/563808 DC : DRAFT SEP 2002 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments
    BS EN 1639:2009 Dentistry. Medical devices for dentistry. Instruments
    I.S. EN 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    08/30184602 DC : DRAFT SEP 2008 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    BS EN ISO 9997:2000 Dental cartridge syringes
    UNI EN 1639 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    EN ISO 9997:1999 Dental cartridge syringes (ISO 9997:1999)
    I.S. EN ISO 9997:2000 DENTAL CARTRIDGE SYRINGES
    EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments

    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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