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    I.S. EN ISO 18397:2016

    Current The latest, up-to-date edition.

    DENTISTRY - POWERED SCALER (ISO 18397:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    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)

    Defines 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.

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

    Development Note Supersedes I.S. EN ISO 15606 & I.S. EN ISO 22374. (04/2016)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    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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