PD CEN/TR 12401:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Dentistry. Guidance on the classification of dental devices and accessories
Hardcopy , PDF
English
30-06-2009
16-04-2025
Foreword
Introduction
1 Scope
2 Classification of dental devices and accessories
3 Proposals for classification of dental devices
and accessories
Bibliography
Gives 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 |
CH/106
|
| DevelopmentNote |
Supersedes BS PD CR 12401. (06/2009)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| Standards | Relationship |
| CEN/TR 12401:2009 | Identical |
| 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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