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
30-11-2009
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 |
CH/106
|
| DevelopmentNote |
Supersedes 08/30184602 DC. (12/2009)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| 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 |
| 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 |
| 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 |
| 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 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 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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