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  • 08/30184602 DC : DRAFT SEP 2008

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS

    Available format(s): 

    Superseded date:  30-11-2009

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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    Comment Closes On
    Committee CH/106
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    EN ISO 3630-3:2015 Dentistry - Endodontic instruments - Part 3: Compactors: pluggers and spreaders (ISO 3630-3:2015)
    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)
    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)
    EN ISO 15087-4:2000 Dental elevators - Part 4: Coupland elevators (ISO 15087-4:2000)
    EN ISO 15087-1:2001 Dental elevators - Part 1: General requirements (ISO 15087-1:1999)
    EN ISO 3823-2:2003/A1:2008 Dentistry - Rotary bur instruments - Part 2: Finishing burs - Amendment 1 (ISO 3823-2:2003/Amd 1:2008)
    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)
    EN ISO 15098-1:2001 Dental tweezers - Part 1: General requirements (ISO 15098-1:2000)
    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)
    EN ISO 15087-2:2000 Dental elevators - Part 2: Warwick James elevators (ISO 15087-2:2000)
    EN ISO 8325:2004 Dentistry - Test methods for rotary instruments (ISO 8325:2004)
    EN ISO 7885:2010 Dentistry - Sterile injection needles for single use (ISO 7885:2010)
    EN 23964:1989/AC1:1990 Dentistry - Dental handpieces - Coupling dimensions (ISO 3964:1982)
    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
    EN 21942-3 : 1993 DENTAL VOCABULARY - DENTAL INSTRUMENTS
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    EN ISO 9173-1:2016 Dentistry - Extraction forceps - Part 1: General requirements (ISO 9173-1:2016)
    EN 29168 : 1994 DENTAL HANDPIECES - HOSE CONNECTORS
    EN ISO 15087-5:2000 Dental elevators - Part 5: Bein elevators (ISO 15087-5:2000)
    EN ISO 7711-1:1998/A1:2009 DENTAL ROTARY INSTRUMENTS - DIAMOND INSTRUMENTS - PART 1: DIMENSIONS, REQUIREMENTS, MARKING AND PACKAGING
    EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
    EN ISO 7711-2:2011 Dentistry - Rotary diamond instruments - Part 2: Discs (ISO 7711-2:2011)
    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)
    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)
    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)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    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)
    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)
    EN ISO 11499:2014 Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)
    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)
    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)
    EN ISO 3823-1:1998 Dental rotary instruments - Burs - Part 1: Steel and carbide burs (ISO 3823-1:1997)
    EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
    EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
    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)
    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)
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