• DIN EN 1640:2010-02

    Current The latest, up-to-date edition.

    Dentistry - Medical devices for dentistry - Equipment

    Available format(s):  Hardcopy, PDF

    Language(s):  English, German

    Published date:  01-02-2010

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

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    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current
    Supersedes

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

    ISO 9680:2014 Dentistry Operating lights
    EN 21942-1 : 1991 DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS
    EN ISO 11498:1999 Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997)
    EN 60825-1:2014/AC:2017-06 SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014)
    ISO 21530:2004 Dentistry — Materials used for dental equipment surfaces — Determination of resistance to chemical disinfectants
    EN ISO 7494-1:2011 Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    EN ISO 7494-2:2015 Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN 21942-4 : 1993 DENTAL VOCABULARY - DENTAL EQUIPMENT
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    EN ISO 11143:2008 Dentistry - Amalgam separators (ISO 11143:2008)
    ISO 6875:2011 Dentistry Patient chair
    ISO 7494-2:2015 Dentistry — Stationary dental units — Part 2: Air, water, suction and wastewater systems
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    EN ISO 21530:2004 Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants (ISO 21530:2004)
    IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    EN 60601-2-22:2013 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    CEN/TR 12401:2009 Dentistry - Guidance on the classification of dental devices and accessories
    EN ISO 6875:2011 Dentistry - Patient chair (ISO 6875:2011)
    EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 3950:2016 Dentistry — Designation system for teeth and areas of the oral cavity
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO/TS 22595-2:2008 Dentistry Plant area equipment Part 2: Compressor systems
    ISO/TS 22595-1:2006 Dentistry Plant area equipment Part 1: Suction systems
    ISO 9687:2015 Dentistry Graphical symbols for dental equipment
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors
    EN ISO 13294:1997 Dental handpieces - Dental air-motors (ISO 13294:1997)
    EN ISO 3950:2016 Dentistry - Designation system for teeth and areas of the oral cavity (ISO 3950:2016)
    EN ISO 10650-2:2007 Dentistry - Powered polymerization activators - Part 2: Light-emitting diode (LED) lamps (ISO 10650-2:2007)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    ISO 7494-1:2011 Dentistry Dental units Part 1: General requirements and test methods
    EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
    EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 10637:1999 Dental equipment High- and medium-volume suction 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
    EN ISO 9680:2014 Dentistry - Operating lights (ISO 9680:2014)
    ISO 10650-2:2007 Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps
    ISO 7488:1991 Dental amalgamators
    ISO 13294:1997 Dental handpieces Dental air-motors
    EN ISO 10650-1:2005 Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps (ISO 10650-1:2004)
    ISO 10650-1:2004 Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps
    ISO 11143:2008 Dentistry Amalgam separators
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