EN 1641:2009
Current
Current
The latest, up-to-date edition.
Dentistry - Medical devices for dentistry - Materials
Published date
28-10-2009
Publisher
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex ZA (informative) - Relationship between this
European Standard and the
Essential Requirements of
EU Directive 93/42/EEC
Bibliography
This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
| Committee |
CEN/TC 55
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| PN EN 1641 : 2010 | Identical |
| NF EN 1641 : 2009 | Identical |
| DIN EN 1641:2010-02 | Identical |
| AS EN 1641-2002 | Identical |
| NBN EN 1641 : 2009 | Identical |
| NEN EN 1641 : 2009 | Identical |
| I.S. EN 1641:2009 | Identical |
| UNI EN 1641 : 2010 | Identical |
| BS EN 1641:2004 | Identical |
| UNE-EN 1641:2010 | Identical |
| SN EN 1641 : 2010 | Identical |
| SS-EN 1641:2009 | Identical |
| NS EN 1641 : 2009 | Identical |
| BS EN 1641:2009 | Identical |
| 02/563845 DC : DRAFT SEP 2002 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| DIN EN 1642:2012-06 | Dentistry - Medical devices for dentistry - Dental implants |
| CEN/TR 12401:2009 | Dentistry - Guidance on the classification of dental devices and accessories |
| CR 12401 : 1996 | DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
| S.R. CEN TR 12401:2009 | DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
| I.S. EN 1642:2011 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| UNI EN 1642 : 2012 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| 08/30184615 DC : DRAFT SEP 2008 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| PD CEN/TR 12401:2009 | Dentistry. Guidance on the classification of dental devices and accessories |
| UNE-EN 1642:2012 | Dentistry - Medical devices for dentistry - Dental implants |
| EN 1642:2011 | Dentistry - Medical devices for dentistry - Dental implants |
| PD CR 12401:2003 | Dentistry. Guidance on the classification of dental devices and accessories |
| BS EN 1642:2011 | Dentistry. Medical devices for dentistry. Dental implants |
| EN ISO 21606:2007 | Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007) |
| EN 21942-1 : 1991 | DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS |
| EN ISO 3107:2011 | Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO 3107:2011) |
| EN ISO 7551:1998 | Dental absorbent points (ISO 7551:1996) |
| ISO 9333:2006 | Dentistry — Brazing materials |
| ISO 21606:2007 | Dentistry — Elastomeric auxiliaries for use in orthodontics |
| EN 21942-2 : 1992 | DENTAL VOCABULARY - DENTAL MATERIALS |
| ISO 6872:2015 | Dentistry — Ceramic materials |
| ISO 6877:2006 | Dentistry Root-canal obturating points |
| EN ISO 6877:2006 | Dentistry - Root-canal obturating points (ISO 6877:2006) |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 24234:2015 | Dentistry Dental amalgam |
| ISO 13716:1999 | Dentistry Reversible-irreversible hydrocolloid impression material systems |
| ISO 20795-1:2013 | Dentistry Base polymers Part 1: Denture base polymers |
| EN ISO 22674:2016 | Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016) |
| EN ISO 9917-1:2007 | Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2007) |
| EN ISO 10271:2011 | Dentistry - Corrosion test methods for metallic materials (ISO 10271:2011) |
| EN ISO 1564:1998 | Dental aqueous impression materials based on agar (ISO 1564:1995) |
| ISO 10271:2011 | Dentistry Corrosion test methods for metallic materials |
| ISO 6874:2015 | Dentistry Polymer-based pit and fissure sealants |
| ISO 4823:2015 | Dentistry Elastomeric impression materials |
| 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) |
| ISO 1942-1:1989 | Dental vocabulary Part 1: General and clinical terms |
| EN ISO 6873:2013 | Dentistry - Gypsum products (ISO 6873:2013) |
| EN ISO 22112:2017 | Dentistry - Artificial teeth for dental prostheses (ISO 22112:2017) |
| EN ISO 4823:2015 | Dentistry - Elastomeric impression materials (ISO 4823:2015) |
| ISO 7491:2000 | Dental materials — Determination of colour stability |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ISO 1563:1990 | Dental alginate impression material |
| ISO 1942-2:1989 | Dental vocabulary Part 2: Dental materials |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| EN ISO 10139-2:2016 | Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2016) |
| ISO 10139-1:2005 | Dentistry Soft lining materials for removable dentures Part 1: Materials for short-term use |
| ISO 15854:2005 | Dentistry Casting and baseplate waxes |
| CEN/TR 12401:2009 | Dentistry - Guidance on the classification of dental devices and accessories |
| ISO 9917-2:2017 | Dentistry — Water-based cements — Part 2: Resin-modified cements |
| ISO 15841:2014 | Dentistry Wires for use in orthodontics |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 3950:2016 | Dentistry — Designation system for teeth and areas of the oral cavity |
| EN 1642:2011 | Dentistry - Medical devices for dentistry - Dental implants |
| ISO 1564:1995 | Dental aqueous impression materials based on agar |
| ISO 3107:2011 | Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements |
| EN 21563:1991 | Alginate dental impression material (ISO 1563:1990) |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 22112:2017 | Dentistry — Artificial teeth for dental prostheses |
| EN ISO 15854:2005 | Dentistry - Casting and baseplate waxes (ISO 15854:2005) |
| ISO 9693:1999 | Metal-ceramic dental restorative systems |
| ISO 22674:2016 | Dentistry — Metallic materials for fixed and removable restorations and appliances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 1942-5:1989 | Dental vocabulary Part 5: Terms associated with testing |
| ISO 4049:2009 | Dentistry Polymer-based restorative materials |
| EN ISO 7491:2000 | Dental materials - Determination of colour stability (ISO 7491:2000) |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| EN ISO 6876:2012 | Dentistry - Root canal sealing materials (ISO 6876:2012) |
| EN ISO 15841:2014 | Dentistry - Wires for use in orthodontics (ISO 15841:2014) |
| ISO 7551:1996 | Dental absorbent points |
| ISO 10139-2:2016 | Dentistry Soft lining materials for removable dentures Part 2: Materials for long-term use |
| EN ISO 3950:2016 | Dentistry - Designation system for teeth and areas of the oral cavity (ISO 3950:2016) |
| ISO 6873:2013 | Dentistry — Gypsum products |
| EN ISO 9917-2:2017 | Dentistry - Water-based cements - Part 2: Resin-modified cements (ISO 9917-2:2017) |
| ISO 9917-1:2007 | Dentistry Water-based cements Part 1: Powder/liquid acid-base cements |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 10477:2004 | Dentistry Polymer-based crown and bridge materials |
| EN ISO 24234:2015 | Dentistry - Dental amalgam (ISO 24234:2015) |
| EN ISO 9693 : 2000 | METAL-CERAMIC DENTAL RESTORATIVE SYSTEMS |
| EN ISO 14155-2:2009 | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
| ISO 6876:2012 | Dentistry — Root canal sealing materials |
| EN ISO 13716:2000 | Dentistry - Reversible-irreversible hydrocolloid impression material systems (ISO 13716:1999) |
| EN ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN ISO 20795-1:2013 | Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2013) |
| EN ISO 10477:2004 | Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004) |
| EN ISO 6874:2015 | Dentistry - Polymer-based pit and fissure sealants (ISO 6874:2015) |
| EN ISO 9333:2006 | Dentistry - Brazing materials (ISO 9333:2006) |
| EN ISO 4049:2009 | Dentistry - Polymer-based restorative materials (ISO 4049:2009) |
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