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I.S. EN 1641:2009

Current
Current

The latest, up-to-date edition.

DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
CEN/TC 55
DocumentType
Standard
Pages
13
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
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
UNI EN 1641 : 2010 Identical
BS EN 1641:2004 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
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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