BS EN 1640:2009
Current
The latest, up-to-date edition.
Dentistry. Medical devices for dentistry. Equipment
Hardcopy , PDF
English
11-30-2009
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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 items of dental equipment used in the practice of dentistry and which are medical devices.
| Committee |
CH/106
|
| DevelopmentNote |
Supersedes 94/508361 DC and 02/563818 DC. (06/2004) Supersedes 08/30184608 DC. (12/2009)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This European Standard specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer.
This European Standard does not apply to dental X-ray equipment.
This European Standard does not apply to any dental instruments connected to an item of dental equipment. These instruments are covered by EN1639.
Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
| Standards | Relationship |
| DIN EN 1640:2010-02 | Identical |
| I.S. EN 1640:2009 | Identical |
| NBN EN 1640 : 2009 | Identical |
| NEN EN 1640 : 2009 | Identical |
| NF EN 1640 : 2009 | Identical |
| SN EN 1640 : 2010 | Identical |
| UNI EN 1640 : 2010 | Identical |
| EN 1640:2009 | Identical |
| NS EN 1640 : 2009 | Identical |
| UNE-EN 1640:2010 | Identical |
| ISO 9680:2014 | Dentistry Operating lights |
| EN 21942-1 : 1991 | DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS |
| EN ISO 11498:1999 | Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997) |
| EN 60825-1:2014/AC:2017-06 | SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014) |
| ISO 21530:2004 | Dentistry — Materials used for dental equipment surfaces — Determination of resistance to chemical disinfectants |
| EN ISO 7494-1:2011 | Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| EN ISO 7494-2:2015 | Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 21942-4 : 1993 | DENTAL VOCABULARY - DENTAL EQUIPMENT |
| 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) |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| EN ISO 11143:2008 | Dentistry - Amalgam separators (ISO 11143:2008) |
| ISO 6875:2011 | Dentistry Patient chair |
| ISO 7494-2:2015 | Dentistry — Stationary dental units — Part 2: Air, water, suction and wastewater systems |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| EN ISO 21530:2004 | Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants (ISO 21530:2004) |
| IEC 60601-2-22:2007+AMD1:2012 CSV | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| EN 60601-2-22:2013 | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| CEN/TR 12401:2009 | Dentistry - Guidance on the classification of dental devices and accessories |
| EN ISO 6875:2011 | Dentistry - Patient chair (ISO 6875:2011) |
| EN 1639:2009 | Dentistry - Medical devices for dentistry - Instruments |
| 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 |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO/TS 22595-2:2008 | Dentistry Plant area equipment Part 2: Compressor systems |
| ISO/TS 22595-1:2006 | Dentistry Plant area equipment Part 1: Suction systems |
| 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 11498:1997 | Dental handpieces Dental low-voltage electrical motors |
| EN ISO 13294:1997 | Dental handpieces - Dental air-motors (ISO 13294:1997) |
| EN ISO 3950:2016 | Dentistry - Designation system for teeth and areas of the oral cavity (ISO 3950:2016) |
| EN ISO 10650-2:2007 | Dentistry - Powered polymerization activators - Part 2: Light-emitting diode (LED) lamps (ISO 10650-2:2007) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 60601-1-4:1996/A1:1999 | MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
| ISO 7494-1:2011 | Dentistry Dental units 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 |
| ISO 10637:1999 | Dental equipment High- and medium-volume suction systems |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| EN ISO 9680:2014 | Dentistry - Operating lights (ISO 9680:2014) |
| ISO 10650-2:2007 | Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps |
| ISO 7488:1991 | Dental amalgamators |
| ISO 13294:1997 | Dental handpieces Dental air-motors |
| EN ISO 10650-1:2005 | Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps (ISO 10650-1:2004) |
| ISO 10650-1:2004 | Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps |
| ISO 11143:2008 | Dentistry Amalgam separators |
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