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BS EN 1639:2009

Current
Current

The latest, up-to-date edition.

Dentistry. Medical devices for dentistry. Instruments
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

11-30-2009

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

Describes general requirements for instruments used in the practice of dentistry and which are medical devices.

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 EN1640.

Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate.

Committee
CH/106/4
DevelopmentNote
Supersedes 08/30184602 DC. (12/2009)
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
UNE-EN 1639:2010 Identical
NF EN 1639 : 2009 Identical
DIN EN 1639:2010-02 Identical
NS EN 1639 : 2009 Identical
I.S. EN 1639:2009 Identical
NEN EN 1639 : 2009 Identical
SN EN 1639:2010 Identical
NBN EN 1639 : 2009 Identical
UNI EN 1639 : 2010 Identical
EN 1639:2009 Identical

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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