• EN ISO 10477:2004

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s): 

    Superseded date:  17-06-2019

    Language(s): 

    Published date:  01-10-2004

    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 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

    Abstract - (Show below) - (Hide below)

    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.

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

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    Status Superseded
    Superseded By

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

    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

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

    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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