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CEN/TR 12401:2009

CEN/TR 12401:2009

Current

Current

The latest, up-to-date edition.

Dentistry - Guidance on the classification of dental devices and accessories

Published date

05-13-2009

Publisher

Comite Europeen de Normalisation

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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

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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