BS EN 1641:2004
Current
Current
The latest, up-to-date edition.
Dentistry. Medical devices for dentistry. Materials
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
14-06-2004
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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
Describes 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.
| Committee |
CH/106/2
|
| DevelopmentNote |
Supersedes 94/508364 DC. (06/2004) Supersedes 08/30184612 DC. (12/2009)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| I.S. EN 1641:2009 | Identical |
| UNI EN 1641 : 2010 | Identical |
| NF EN 1641 : 2009 | Identical |
| DIN EN 1641:2010-02 | Identical |
| NBN EN 1641 : 2009 | Identical |
| NEN EN 1641 : 2009 | Identical |
| EN 1641:2009 | Identical |
| UNE-EN 1641:2010 | Identical |
| SN EN 1641 : 2010 | Identical |
| NS EN 1641 : 2009 | Identical |
| 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) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.