• DIN EN ISO 18397:2016-09

    Current The latest, up-to-date edition.

    DENTISTRY - POWERED SCALER (ISO 18397:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  German, English

    Published date:  01-01-2016

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    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. Also contains specifications on manufacturers' instructions, marking and packaging.

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

    Development Note Supersedes DIN EN ISO 15606 & DIN EN ISO 22374. (09/2016)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    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
    DIN EN ISO 15223-1:2015-08 (Draft) MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
    DIN EN ISO 9687:2015-05 DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
    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
    DIN EN 61672-1:2014-07 ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013)
    DIN EN ISO 21531:2009-08 DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
    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
    DIN EN ISO 5349-2:2015-12 MECHANICAL VIBRATION - MEASUREMENT AND EVALUATION OF HUMAN EXPOSURE TO HAND-TRANSMITTED VIBRATION - PART 2: PRACTICAL GUIDANCE FOR MEASUREMENT AT THE WORKPLACE (ISO 5349-2:2001 + AMD 1:2015)
    DIN EN ISO 17664:2016-06 (Draft) PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
    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
    DIN EN 62366-1 : 2017 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015 + COR1:2016)
    DIN EN ISO 7494-1:2011-11 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011)
    DIN EN ISO 5349-1:2001-12 MECHANICAL VIBRATIONS - MEASUREMENT AND EVALUATION OF HUMAN EXPOSURE TO HAND-TRANSMITTED VIBRATION - PART 1: GENERAL REQUIREMENTS
    ISO 1942:2009 Dentistry Vocabulary
    DIN EN ISO 9168:2009-10 DENTISTRY - HOSE CONNECTORS FOR AIR DRIVEN DENTAL HANDPIECES
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    DIN EN ISO 14457:2016-05 (Draft) DENTISTRY - HANDPIECES AND MOTORS (ISO 14457:2017)
    ISO 9687:2015 Dentistry Graphical symbols for dental equipment
    DIN EN 80601-2-60 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT (IEC 80601-2-60:2012)
    ISO 5349-1:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements
    DIN EN ISO 1942:2011-03 Dentistry - Vocabulary (ISO 1942:2009, Corrected version 2010-03-01)
    ISO 7494-1:2011 Dentistry Dental units Part 1: General requirements and test methods
    DIN ISO 80601-2-60 : DRAFT 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT
    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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