CR 12401 : 1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
01-07-2003
12-01-2013
Foreword
Introduction
1 Scope
2 Classification of dental devices and accessories
3 Proposals for classification of dental devices
Bibliography
Gives guidelines on the application of classification rules in Council Directive 93/42 EEC of 14 June 1993 relevant to medical devices as they apply to dental devices and accessories.
| Committee |
TC 55
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PD CR 12401:2003 | Identical |
| PD 6618:1997 | Identical |
| SN CR 12401 : 1996 | Identical |
| NEN CR 12401 : 1996 | Identical |
| DIN V 13974:2003-10 | Corresponds |
| NF CR 12401 : 97 FD | Identical |
| UNE-CR 12401:1997 | Identical |
| 02/563808 DC : DRAFT SEP 2002 | BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| 02/563845 DC : DRAFT SEP 2002 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| 05/30099256 DC : DRAFT MAY 2005 | ISO 16059 - DENTISTRY - REQUIRED ELEMENTS FOR CODIFICATION USED IN DATA EXCHANGE |
| 02/563832 DC : DRAFT SEP 2002 | BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
| ISO/TR 15300:2001 | Dentistry Application of OSI clinical codification to the classification and coding of dental products |
| 02/563818 DC : DRAFT SEP 2002 | BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| EN 21942-1 : 1991 | DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS |
| EN 21942-2 : 1992 | DENTAL VOCABULARY - DENTAL MATERIALS |
| ISO 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| EN ISO 13488 : 2000 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| EN 21942-4 : 1993 | DENTAL VOCABULARY - DENTAL EQUIPMENT |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 724 : 1994 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| 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 |
| EN 50103 : 1995 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY |
| ISO 1942-5:1989 | Dental vocabulary Part 5: Terms associated with testing |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| 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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