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  • EN ISO 14457:2017

    Current The latest, up-to-date edition.

    Dentistry - Handpieces and motors (ISO 14457:2017)

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    Published date:  06-12-2017

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Classification of handpieces
    5 Requirements and performance
    6 Sampling
    7 Testing
    8 Instructions for use, maintenance and service
    9 Technical description
    10 Marking
    11 Labelling
    12 Packaging
    Annex A (informative) - Handpiece and motor category tree
    Annex B (informative) - Test report form
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 14457:2017 specifies requirements and test methods for handpieces and motors used in dentistry for treatment of patients and having patient contact, regardless of their construction. It also specifies requirements for manufacturer's information, marking and packaging.ISO 14457:2017 is applicable to the following:a) straight and angle handpieces;b) high-speed air turbine handpieces;c) air motors;d) electrical motors;e) prophy handpieces.ISO 14457:2017 is not applicable to the following:- intraoral camera handpieces;- powered polymerization handpieces;- air-powered scalers;- electrical-powered scalers;- powder jet handpieces;- multifunction handpieces (syringes).NOTE See Annex A for clarification of handpieces and motor types covered by ISO 14457:2017.

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

    Committee CEN/TC 55
    Development Note Supersedes EN ISO 11498, EN ISO 13294, EN ISO 7785-1 & EN ISO 7785-2. (11/2012)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

    ISO 21531:2009 Dentistry Graphical symbols for dental instruments
    ISO 6507-1:2005 Metallic materials Vickers hardness test Part 1: Test method
    ISO 9168:2009 Dentistry Hose connectors for air driven dental handpieces
    ISO 5349-2:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 2: Practical guidance for measurement at the workplace
    IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 13295:2007 Dentistry — Mandrels for rotary instruments
    ISO 1797:2017 Dentistry — Shanks for rotary and oscillating instruments
    ISO 3964:2016 Dentistry — Coupling dimensions for handpiece connectors
    ISO 1942:2009 Dentistry Vocabulary
    ISO 2768-2:1989 GENERAL TOLERANCES - PART 2: GEOMETRICAL TOLERANCES FOR FEATURES WITHOUT INDIVIDUAL TOLERANCE INDICATIONS
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 9687:2015 Dentistry Graphical symbols for dental equipment
    ISO 5349-1:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements
    ISO 7494-1:2011 Dentistry Dental units Part 1: General requirements and test methods
    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 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    View more information

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