CEN/TR 12401:2009
Current
Current
The latest, up-to-date edition.
Dentistry - Guidance on the classification of dental devices and accessories
Published date
13-05-2009
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Foreword
Introduction
1 Scope
2 Classification of dental devices and accessories
3 Proposals for classification of dental devices
and accessories
Bibliography
This CEN Technical Report provides guidance on the application of the classification rules in Council Directive 93/42 EEC of 14 June 1993, amended by Directive 2007/47/EC, concerning medical devices as they pertain to dental devices and accessories.
| Committee |
CEN/TC 55
|
| DevelopmentNote |
Supersedes CR 12401 (01/2004) Supersedes NEN CR 12401. (08/2009)
|
| DocumentType |
Technical Report
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| PD CEN/TR 12401:2009 | Identical |
| UNE-CEN/TR 12401:2009 IN | Identical |
| NEN NPR CEN/TR 12401 : 2009 | Identical |
| FD CEN/TR 12401 : 2009 FD | Identical |
| DIN SPEC 1012;DIN-Fachbericht CEN/TR 12401:2009-08 | Identical |
| PD CR 12401:2003 | Identical |
| S.R. CEN TR 12401:2009 | Identical |
| I.S. CEN TR 12401:2003 | Identical |
| 08/30184612 DC : DRAFT SEP 2008 | BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
| DIN EN 1642:2012-06 | Dentistry - Medical devices for dentistry - Dental implants |
| DIN EN 1639:2010-02 | Dentistry - Medical devices for dentistry - Instruments |
| DIN EN 1641:2010-02 | Dentistry - Medical devices for dentistry - Materials |
| DIN EN 1640:2010-02 | Dentistry - Medical devices for dentistry - Equipment |
| BS EN 1640:2009 | Dentistry. Medical devices for dentistry. Equipment |
| BS EN 1639:2009 | Dentistry. Medical devices for dentistry. Instruments |
| I.S. EN 1642:2011 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| I.S. EN 1639:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| I.S. EN 1640:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| I.S. EN 1641:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
| UNI EN 1642 : 2012 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| 08/30184602 DC : DRAFT SEP 2008 | BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| 08/30184615 DC : DRAFT SEP 2008 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| UNI EN 1641 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
| UNI EN 1640 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| UNI EN 1639 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| 08/30184608 DC : DRAFT SEP 2008 | BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| ISO 16059:2007 | Dentistry — Required elements for codification used in data exchange |
| UNE-EN 1642:2012 | Dentistry - Medical devices for dentistry - Dental implants |
| BS EN 1641:2004 | Dentistry. Medical devices for dentistry. Materials |
| EN 1641:2009 | Dentistry - Medical devices for dentistry - Materials |
| EN 1642:2011 | Dentistry - Medical devices for dentistry - Dental implants |
| EN 1639:2009 | Dentistry - Medical devices for dentistry - Instruments |
| EN 1640:2009 | Dentistry - Medical devices for dentistry - Equipment |
| BS EN 1642:2011 | Dentistry. Medical devices for dentistry. Dental implants |
| EN 21942-1 : 1991 | DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS |
| EN 21942-2 : 1992 | DENTAL VOCABULARY - DENTAL MATERIALS |
| 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) |
| EN 1641:2009 | Dentistry - Medical devices for dentistry - Materials |
| EN 21942-3 : 1993 | DENTAL VOCABULARY - DENTAL INSTRUMENTS |
| EN 1639:2009 | Dentistry - Medical devices for dentistry - Instruments |
| EN 1642:2011 | Dentistry - Medical devices for dentistry - Dental implants |
| EN 1640:2009 | Dentistry - Medical devices for dentistry - Equipment |
| CEN ISO/TR 14969:2005 | Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) |
| ISO 1942-5:1989 | Dental vocabulary Part 5: Terms associated with testing |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
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