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  • EN 1641:2009

    Current The latest, up-to-date edition.

    Dentistry - Medical devices for dentistry - Materials

    Available format(s): 

    Language(s): 

    Published date:  28-10-2009

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 55
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    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

    Standards Referencing This Book - (Show below) - (Hide below)

    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
    EN ISO 7405:2008/A1:2013 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
    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 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    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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