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  • EN ISO 7494-1:2011

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)

    Available format(s): 

    Superseded date:  31-07-2019

    Language(s): 

    Published date:  15-08-2011

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Classification
    5 Requirements
    6 Sampling
    7 Testing
    8 Manufacturer's instructions
    9 Marking
    10 Packaging
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 7494-1:2011 specifies requirements and test methods for dental units, regardless of whether or not they are electrically powered.ISO 7494-1:2011 also specifies requirements for manufacturer's instructions, marking and packaging.

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

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    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment
    BS EN 1640:2009 Dentistry. Medical devices for dentistry. Equipment
    I.S. EN 1640:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
    UNI EN 1640 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
    08/30184608 DC : DRAFT SEP 2008 BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
    EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment

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

    ISO 11226:2000 Ergonomics — Evaluation of static working postures
    ISO 21530:2004 Dentistry — Materials used for dental equipment surfaces — Determination of resistance to chemical disinfectants
    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 4073:2009 Dentistry Information system on the location of dental equipment in the working area of the oral health care provider
    ISO 6875:2011 Dentistry Patient chair
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 1942:2009 Dentistry Vocabulary
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
    ISO 9687:2015 Dentistry Graphical symbols for dental equipment
    ISO 11144:1995 Dental equipment Connections for supply and waste lines
    ISO 6385:2016 Ergonomics principles in the design of work systems
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    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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