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EN ISO 10477:2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004)
Superseded date

06-17-2019

Published date

10-01-2004

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
  5.1 Biocompatibility
  5.2 Sensitivity to ambient light, Type 2, Class 2
       polymer-based crown and bridge materials
  5.3 Depth of cure, Type 2, Class 2 polymer-based
       crown and bridge materials
  5.4 Surface finish
  5.5 Flexural strength
  5.6 Bond strength
  5.7 Water sorption
  5.8 Solubility
  5.9 Shade consistency
  5.10 Colour stability
6 Sampling
  6.1 For all tests
  6.2 For test of shade consistency
  6.3 For test of colour stability
7 Test methods
  7.1 General
  7.2 Visual inspection
  7.3 Sensitivity to ambient light, Type 2, Class 2
       polymer-based crown and bridge materials
  7.4 Depth of cure, Type 2, Class 2 polymer-based
       crown and bridge materials
  7.5 Surface finish
  7.6 Flexural strength
  7.7 Bond strength
  7.8 Water sorption and solubility
  7.9 Shade consistency and colour stability
8 Packaging and labelling
  8.2 Labelling
9 Manufacturer's instructions and information for the user
  9.1 Instructions for use
  9.2 Shade guide
Bibliography

ISO 10477:2004 classifies polymer-based dental crown and bridge materials and specifies their requirements. It also specifies the test methods to be used to determine compliance with these requirements. ISO 10477:2004 is applicable to polymer-based dental crown and bridge materials for laboratory-fabricated permanent facings or anterior crowns that may or may not be attached to a metal substructure. It also applies to polymer-based dental crown and bridge materials for which the manufacturer claims adhesion to the metal substructure without macromechanical retention such as beads or wires.ISO 10477:2004 is not applicable to polymer-based materials that are used to make crowns, veneers or repairs in the operatory, nor does it cover the application of those materials to stress-bearing areas of posterior teeth.

Committee
CEN/TC 55
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

08/30184612 DC : DRAFT SEP 2008 BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
02/563832 DC : DRAFT SEP 2002 BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
DIN EN 1641:2010-02 Dentistry - Medical devices for dentistry - Materials
I.S. EN 1641:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
UNI EN 1641 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
BS EN 1641:2004 Dentistry. Medical devices for dentistry. Materials
EN 1641:2009 Dentistry - Medical devices for dentistry - Materials

ISO 6507-2:2005 Metallic materials Vickers hardness test Part 2: Verification and calibration of testing machines
ISO 6874:2015 Dentistry Polymer-based pit and fissure sealants
ISO 7491:2000 Dental materials — Determination of colour stability
ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
ISO 1562:2004 Dentistry Casting gold alloys
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 4049:2009 Dentistry Polymer-based restorative materials
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
ISO 6344-1:1998 Coated abrasives Grain size analysis Part 1: Grain size distribution test
ISO 8891:1998 Dental casting alloys with noble metal content of at least 25 % but less than 75 %

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