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  • EN ISO 20608:2018

    Current The latest, up-to-date edition.

    Dentistry - Powder jet handpieces and powders (ISO 20608:2018)

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    Published date:  16-05-2018

    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 handpieces
    5 Requirements
    6 Sampling
    7 Measurement and test methods
    8 Instructions for use, maintenance and service
    9 Technical description
    10 Marking and labelling
    11 Packaging
    Annex A (informative) - Example of a test report

    Abstract - (Show below) - (Hide below)

    ISO 20608:2018 specifies the general requirements, test methods, manufacturer's information, marking and packaging, independently of the design of the powder jet handpieces (see Figure 1).ISO 20608:2018 applies to powder jet handpieces and their associated powders for use in the field of dentistry. They are used on patients to remove dental debris, discolourations and plaque and to clean and polish teeth where abrasion is a side effect.ISO 20608:2018 is also applicable to powder jet handpieces and their associated powders that are used in dentistry for air driven abrasion, e.g. minimally invasive cavity preparation, preparation of surfaces for adhesives and for the removal of cement residues where abrasion is part of the desired outcome.ISO 20608:2018 is not applicable for the dental units that are employed to supply the powder jet handpieces.ISO 20608:2018 is not applicable to dental prophylaxis handpieces (contra angles), or electrically driven plaque removers (scalers) or multifunctional handpieces (syringes).

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

    Committee CEN/TC 55
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    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 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 11014:2009 Safety data sheet for chemical products Content and order of sections
    ISO 5349-1:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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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