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  • BS EN ISO 7885:2010

    Current The latest, up-to-date edition.

    Dentistry. Sterile injection needles for single use

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-03-2010

    Publisher:  British Standards Institution

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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)

    Specifies 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.

    Scope - (Show below) - (Hide below)

    This International Standard gives dimensional and performance requirements for sterile injection needles for single use which are used in dental cartridge syringes complying with ISO9997 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 CH/106/4
    Development Note Renumbers and supersedes BS ISO 7885 (03/1999) 1999 Version incorporates amendment 10437 to BS ISO 7885 Supersedes 99/563225 DC (06/2005) Supersedes 95/560016 DC. (03/2007) Supersedes 09/30168835 DC. (03/2010) Reviewed and confirmed by BSI, September 2015. (09/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    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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