UNI EN 1640 : 2010
Current
Current
The latest, up-to-date edition.
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
Published date
01-21-2010
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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 dental equipment used in the practice of dentistry and which are medical devices.
| Committee |
CT 44
|
| DevelopmentNote |
Bilingual (Italian + English) version issued in JULY 2010. (03/2013)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN 1640 : 2009 | Identical |
| NBN EN 1640 : 2009 | Identical |
| NEN EN 1640 : 2009 | Identical |
| NS EN 1640 : 2009 | Identical |
| I.S. EN 1640:2009 | Identical |
| SN EN 1640 : 2010 | Identical |
| UNE-EN 1640:2010 | Identical |
| BS EN 1640:2009 | Identical |
| EN 1640:2009 | Identical |
| DIN EN 1640:2010-02 | 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 |
| 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 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 |
| 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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