I.S. EN 1639:2009
Current
The latest, up-to-date edition.
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
Hardcopy , PDF
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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.
Committee |
CEN/TC 55
|
DocumentType |
Standard
|
Pages |
17
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Current
|
Supersedes |
Standards | Relationship |
NEN EN 1639 : 2009 | Identical |
SN EN 1639:2010 | Identical |
NBN EN 1639 : 2009 | Identical |
UNI EN 1639 : 2010 | Identical |
EN 1639:2009 | Identical |
UNE-EN 1639:2010 | Identical |
NF EN 1639 : 2009 | Identical |
DIN EN 1639:2010-02 | Identical |
NS EN 1639 : 2009 | Identical |
BS 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 |
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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