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  • EN ISO 18397:2016

    Current The latest, up-to-date edition.

    Dentistry - Powered scaler (ISO 18397:2016)

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    Language(s): 

    Published date:  24-02-2016

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Classification of scaler 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) - Calculation example for power output

    Abstract - (Show below) - (Hide below)

    ISO 18397:2016 specifies requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo, ferrostrictive and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. It also contains specifications on manufacturers' instructions, marking and packaging.

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

    Committee CEN/TC 55
    Development Note Supersedes EN ISO 22374 and EN ISO 15606. (03/2016)
    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 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 14457:2017 Dentistry — Handpieces and motors
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    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 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
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