• EN ISO 7494-2:2015

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)

    Available format(s): 

    Withdrawn date:  31-10-2015

    Language(s): 

    Published date:  08-04-2015

    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 Tests
    8 Manufacturer's instructions for use
    9 Technical description
    Annex A (informative) - Schematic diagram of possible
            components and connections in a dental unit
    Annex B (informative) - Test sequences
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 7494-2:2015 specifies requirements and test methods concerninga) the configuration of dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,b) the materials, design, and construction of the compressed air and water system within the dental unit,c) the quality for incoming water and air, andd) the performance of dental unit suction system.ISO 7494-2:2015 also specifies requirements for instructions for use and technical description.ISO 7494-2:2015 is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in ISO 7494-2:2015.

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

    Committee CEN/TC 55
    Development Note Supersedes PREN ISO 7494-2 & EN ISO 11144. (04/2015)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Withdrawn
    Supersedes

    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
    BS EN 80601-2-60:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental equipment
    EN 80601-2-60:2015 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
    EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment

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

    ISO 9168:2009 Dentistry Hose connectors for air driven dental handpieces
    EN 1717:2000 Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 8573-1:2010 Compressed air Part 1: Contaminants and purity classes
    ISO 1942:2009 Dentistry Vocabulary
    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/TS 11080:2009 Dentistry Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water
    ISO 10637:1999 Dental equipment High- and medium-volume suction systems
    ISO 11143:2008 Dentistry Amalgam separators
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