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  • EN ISO 7885:2010

    Current The latest, up-to-date edition.

    Dentistry - Sterile injection needles for single use (ISO 7885:2010)

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    Published date:  15-02-2010

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements of assembled needle and hub
    5 Requirements of needle tubing
    6 Requirements of hub
    7 Requirements of the primary container
    8 Sterility
    9 Labelling
    Annex A (informative) - Imperial thread sizes
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 7885:2010 gives dimensional and performance requirements for sterile injection needles for single use which are used in dental cartridge syringes complying with ISO 9997 for injection of dental local anaesthetics. It further specifies requirements with respect to their packaging, labelling and colour coding. It does not cover needles for special applications or techniques.Only the materials used for the construction of the needle tubing are specified.

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

    Committee CEN/TC 55
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    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
    UNI EN 1639 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments

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

    ISO 21533:2003 Dentistry Reusable cartridge syringes intended for intraligamentary injections
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    ISO 9997:1999 Dental cartridge syringes
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 1942:2009 Dentistry Vocabulary
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    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 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11499:2014 Dentistry — Single-use cartridges for local anaesthetics
    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 6009:2016 Hypodermic needles for single use Colour coding for identification
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