CEN/TR 12401:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Dentistry - Guidance on the classification of dental devices and accessories
13-05-2009
16-04-2025
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 |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| PD CEN/TR 12401:2009 | 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 |
| S.R. CEN TR 12401:2009 | Equivalent |
| DS CEN/TR 12401 : 2009 | Identical |
| PD CR 12401:2003 | Identical |
| S.R. CEN TR 12401:2009 | Identical |
| UNE-CEN/TR 12401:2009 IN | 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 |
| 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 |
| 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 |
| 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 |
| UNE-EN 1642:2012 | 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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