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  • EN 1639:2009

    Current The latest, up-to-date edition.

    Dentistry - Medical devices for dentistry - Instruments

    Available format(s): 

    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 instruments used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, reprocessing, packaging, marking, labelling, and information supplied by the manufacturer.This European Standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by EN 1640.Tests for demonstrating compliance with this European 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)

    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
    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
    02/563818 DC : DRAFT SEP 2002 BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
    EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
    PD CEN/TR 12401:2009 Dentistry. Guidance on the classification of dental devices and accessories
    PD CR 12401:2003 Dentistry. Guidance on the classification of dental devices and accessories

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

    ISO 21531:2009 Dentistry Graphical symbols for dental instruments
    ISO 15087-3:2000 Dental elevators — Part 3: Cryer elevators
    EN ISO 3630-3:2015 Dentistry - Endodontic instruments - Part 3: Compactors: pluggers and spreaders (ISO 3630-3:2015)
    ISO 13397-4:1997 Periodontal curettes, dental scalers and excavators Part 4: Dental excavators Discoid-type
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    ISO 9168:2009 Dentistry Hose connectors for air driven dental handpieces
    ISO 7885:2010 Dentistry Sterile injection needles for single use
    EN ISO 13397-4:1997 Periodontal curettes, dental scalers and excavators - Part 4: Dental excavators - Discoid-type (ISO 13397-4:1997)
    EN ISO 2157:2016 Dentistry - Nominal diameters and designation code numbers for rotary instruments (ISO 2157:2016)
    EN ISO 13397-3:1996 Periodontal curettes, dental scalers and excavators - Part 3: Dental scalers, H-type (ISO 13397-3:1996)
    EN ISO 15087-6:2000 Dental elevators - Part 6: Flohr elevators (ISO 15087-6:2000)
    ISO 10323:2013 Dentistry — Bore diameters for rotary instruments such as discs and wheels
    EN ISO 3630-1:2008 Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO 3630-1:2008)
    EN 21942-1 : 1991 DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS
    EN ISO 13397-2:2005/A1:2012 DENTISTRY - PERIODONTAL CURETTES, DENTAL SCALERS AND EXCAVATORS - PART 2: PERIODONTAL CURETTES OF GR-TYPE (ISO 13397-2:2005)
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 21533:2003 Dentistry Reusable cartridge syringes intended for intraligamentary injections
    ISO 15087-4:2000 Dental elevators — Part 4: Coupland elevators
    ISO 7711-2:2011 Dentistry Rotary diamond instruments Part 2: Discs
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    EN ISO 15087-4:2000 Dental elevators - Part 4: Coupland elevators (ISO 15087-4:2000)
    ISO 13397-3:1996 Periodontal curettes, dental scalers and excavators — Part 3: Dental scalers — H-type
    EN ISO 15087-1:2001 Dental elevators - Part 1: General requirements (ISO 15087-1:1999)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 1797-2:1992 Dental rotary instruments Shanks Part 2: Shanks made of plastics
    EN ISO 3823-2:2003/A1:2008 Dentistry - Rotary bur instruments - Part 2: Finishing burs - Amendment 1 (ISO 3823-2:2003/Amd 1:2008)
    ISO 3630-3:2015 Dentistry Endodontic instruments Part 3: Compactors: pluggers and spreaders
    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)
    EN ISO 3630-2:2013 Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2013)
    EN ISO 1797-2:1995 Dental rotary equipment - Shanks - Part 2: Shanks made of plastics (ISO 1797-2:1992)
    ISO 1942-1:1989 Dental vocabulary Part 1: General and clinical terms
    ISO 21671:2006 Dentistry Rotary polishers
    EN ISO 15098-1:2001 Dental tweezers - Part 1: General requirements (ISO 15098-1:2000)
    ISO 13295:2007 Dentistry — Mandrels for rotary instruments
    EN ISO 15098-2:2000 Dental tweezers - Part 2: Meriam types (ISO 15098-2:2000)
    EN ISO 10323:2013 Dentistry - Bore diameters for rotary instruments such as discs and wheels (ISO 10323:2013)
    ISO 15087-6:2000 Dental elevators — Part 6: Flohr elevators
    EN ISO 15087-2:2000 Dental elevators - Part 2: Warwick James elevators (ISO 15087-2:2000)
    EN ISO 21531:2009 Dentistry - Graphical symbols for dental instruments (ISO 21531:2009)
    EN ISO 8325:2004 Dentistry - Test methods for rotary instruments (ISO 8325:2004)
    ISO 15606:1999 Dental handpieces Air-powered scalers and scaler tips
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    EN ISO 7885:2010 Dentistry - Sterile injection needles for single use (ISO 7885:2010)
    ISO 15098-1:1999 Dental tweezers Part 1: General requirements
    EN 23964:1989/AC1:1990 Dentistry - Dental handpieces - Coupling dimensions (ISO 3964:1982)
    ISO 13397-1:1995 Periodontal curettes, dental scalers and excavators Part 1: General requirements
    EN ISO 13295:2007 Dentistry - Mandrels for rotary instruments (ISO 13295:2007)
    CEN/TR 12401:2009 Dentistry - Guidance on the classification of dental devices and accessories
    ISO 1942-3:1989 Dental vocabulary Part 3: Dental instruments
    ISO 3823-2:2003 Dentistry Rotary bur instruments Part 2: Finishing burs
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 1797-1:2011 Dentistry Shanks for rotary instruments Part 1: Shanks made of metals
    ISO 3823-1:1997 Dental rotary instruments — Burs — Part 1: Steel and carbide burs
    EN 21942-3 : 1993 DENTAL VOCABULARY - DENTAL INSTRUMENTS
    ISO 3964:2016 Dentistry — Coupling dimensions for handpiece connectors
    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
    EN ISO 9173-1:2016 Dentistry - Extraction forceps - Part 1: General requirements (ISO 9173-1:2016)
    ISO 9997:1999 Dental cartridge syringes
    EN 29168 : 1994 DENTAL HANDPIECES - HOSE CONNECTORS
    EN ISO 15087-5:2000 Dental elevators - Part 5: Bein elevators (ISO 15087-5:2000)
    ISO 7711-1:1997 Dental rotary instruments Diamond instruments Part 1: Dimensions, requirements, marking and packaging
    EN ISO 7711-1:1998/A1:2009 DENTAL ROTARY INSTRUMENTS - DIAMOND INSTRUMENTS - PART 1: DIMENSIONS, REQUIREMENTS, MARKING AND PACKAGING
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
    ISO 15087-5:2000 Dental elevators — Part 5: Bein elevators
    ISO 15098-2:2000 Dental tweezers Part 2: Meriam types
    EN ISO 7711-2:2011 Dentistry - Rotary diamond instruments - Part 2: Discs (ISO 7711-2:2011)
    ISO 15098-3:2000 Dental tweezers Part 3: College types
    ISO 3630-2:2013 Dentistry — Endodontic instruments — Part 2: Enlargers
    ISO 2157:2016 Dentistry Nominal diameters and designation code numbers for rotary instruments
    EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
    ISO 15087-1:1999 Dental elevators — Part 1: General requirements
    ISO 7785-1:1997 Dental handpieces Part 1: High-speed air turbine handpieces
    EN ISO 1797-1:2011 Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals (ISO 1797-1:2011)
    EN ISO 13402:2000 Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:1995)
    ISO 7785-2:1995 Dental handpieces Part 2: Straight and geared angle handpieces
    EN ISO 7785-1:1999 Dental handpieces - Part 1: High-speed air turbine handpieces (ISO 7785-1:1997)
    EN ISO 15087-3 : 2000 Dental elevators - Part 3: Cryer elevators (ISO 15087-3:2000)
    EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
    ISO 15087-2:2000 Dental elevators — Part 2: Warwick James elevators
    ISO 7153-1:2016 Surgical instruments Materials Part 1: Metals
    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 7492:1997 Dental explorers
    EN ISO 9997:1999 Dental cartridge syringes (ISO 9997:1999)
    EN ISO 7153-1:2016 Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)
    ISO 9173-1:2016 Dentistry — Extraction forceps — Part 1: General requirements
    EN ISO 13397-1:1995 Periodontal curettes, dental scalers and excavators - Part 1: General requirements (ISO 13397-1:1995)
    EN ISO 15606:1999 Dental handpieces - Air-powered scalers and scaler tips (ISO 15606:1999)
    ISO 13397-2:2005 Dentistry Periodontal curettes, dental scalers and excavators Part 2: Periodontal curettes of Gr-type
    ISO 13402:1995 Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure
    EN ISO 11499:2014 Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)
    EN ISO 3950:2016 Dentistry - Designation system for teeth and areas of the oral cavity (ISO 3950:2016)
    EN ISO 15883-1:2009/A1:2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)
    EN ISO 15098-3:2000 Dental tweezers - Part 3: College types (ISO 15098-3:2000)
    ISO 7711-3:2004 Dentistry Diamond rotary instruments Part 3: Grit sizes, designation and colour code
    EN ISO 17665-1 : 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
    ISO 8325:2004 Dentistry — Test methods for rotary instruments
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 11499:2014 Dentistry — Single-use cartridges for local anaesthetics
    EN ISO 3823-1:1998 Dental rotary instruments - Burs - Part 1: Steel and carbide burs (ISO 3823-1:1997)
    ISO 3630-1:2008 Dentistry Root-canal instruments 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
    EN ISO 7785-2:1997 Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-2:1995)
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    EN 13060:2014 Small steam sterilizers
    EN ISO 7711-3:2004 Dentistry - Diamond rotary instruments - Part 3: Grit sizes, designation and colour code (ISO 7711-3:2004)
    EN ISO 21671:2006/A1:2011 Dentistry - Rotary polishers - Amendment 1 (ISO 21671:2006/Amd 1:2011)
    EN ISO 9873:2017 Dentistry - Intra-oral mirrors (ISO 9873:2017)
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 9873:2017 Dentistry Intra-oral mirrors
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