• EN 1640:2009

    Current The latest, up-to-date edition.

    Dentistry - Medical devices for dentistry - Equipment

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    Language(s): 

    Published date:  28-10-2009

    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 Requirements
    Annex ZA (informative) - Relationship between this
                             European Standard and the
                             Essential Requirements of
                             EU Directive 93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    This European Standard specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer.This European Standard does not apply to dental X-ray equipment.This European Standard does not apply to any dental instruments connected to an item of dental equipment. These instruments are covered by EN 1639.Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

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

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

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

    02/563808 DC : DRAFT SEP 2002 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    CEN/TR 12401:2009 Dentistry - Guidance on the classification of dental devices and accessories
    CR 12401 : 1996 DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES
    S.R. CEN TR 12401:2009 DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES
    BS EN 1639:2009 Dentistry. Medical devices for dentistry. Instruments
    I.S. EN 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    08/30184602 DC : DRAFT SEP 2008 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments
    UNI EN 1639 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    PD CEN/TR 12401:2009 Dentistry. Guidance on the classification of dental devices and accessories
    EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
    PD CR 12401:2003 Dentistry. Guidance on the classification of dental devices and accessories

    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
    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    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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