ISO/TC 106/SC 2 - Prosthodontic materials

This document specifies the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use. This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

This document specifies the requirements and their test methods for elastomeric impression and bite registration materials. NOTE This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

This document specifies the classification of and requirements for dental casting and dental baseplate waxes together with the test methods to be employed to determine compliance with these requirements. This document does not apply to waxes supplied for additive manufacturing or CAD/CAM-based procedures.

This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements. This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.

This document specifies test methods and procedures to determine the corrosion behaviour of metallic materials used in the oral cavity. It is intended that these test methods and procedures be referred to in individual International Standards specifying such metallic materials. This document is not applicable to dental instruments.

This document specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures and overdentures), superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.

This document specifies requirements for tooth-like colour representations made of ceramic materials used to determine the tooth colour in the patient's mouth or to check the colour of dental prosthesis, which are referred to as colour tabs in this document. The colour coordinates of colour tabs are left to the manufacturers' discretion. Resources for visualizing the colours of ceramic and other masses, e.g. mass shade guides and colour patterns for certain ceramic and other masses, do not fall into the scope of this document. They can be manufactured from any materials and serve solely to illustrate the colour effect; they do not serve to determine colour inside the mouth.

This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material. For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

ISO 28319:2018 specifies requirements and test methods for laser welding and the filler materials thereto used in the dental laboratory for welding of metallic restorations and appliances. For filler materials used in laser welding, this document also specifies the information given in the instructions for use, marking and labelling.

ISO 10139-1:2018 specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis.

ISO/TS 19736:2017 specifies a test method for bonding of polymer teeth to denture base materials. This test method is not designed to prove the properties of polymer teeth and denture base materials.

ISO 22112:2017 specifies the classification, requirements, and test methods for artificial teeth such as ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.

ISO/TR 28642:2016 identifies three types of topics related to shade conformity and interconvertibility of monochromatic and polychromatic tissues and materials related to the discipline of dentistry; it describes visual and instrumental methods for assessment of these topics. It suggests interpretation of the findings through colour difference thresholds and provides guidelines for future standardization related to dental shade conformity and interconvertibility. It also includes guidelines related to colour vision of persons undertaking visual colour assessments and instructions for reporting of colour and colour difference assessments.

ISO 13078-2:2016 determines a degree of firing to be implemented by the user. It represents a test method for adapting the firing program of a dental furnace by determining the degree of firing of fired test specimens for a dental ceramic. The test method is suitable for powdered dental ceramics according to ISO 6872, Type I. The test method enables monitoring of the temperature control in the dental furnace by evaluating the firing degree of a dental ceramic. The test method is also suitable for evaluating the reproducibility of the firings in a dental furnace or for comparing several dental furnaces.

ISO 10139-2:2016 specifies requirements for softness, adhesion, water sorption and water solubility, as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.

ISO 22674:2016 classifies metallic materials that are suitable for the fabrication of dental restorations and appliances, including metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses, and specifies their requirements. Furthermore, it specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for the use of these materials, including products delivered for sale to a third party. ISO 22674:2016 does not apply to alloys for dental amalgam (ISO 24234), dental brazing materials (ISO 9333), or metallic materials for orthodontic appliances (ISO 15841) (e.g. wires, brackets, bands and screws).

ISO 15912:2016 gives requirements and test methods for determining the compliance of dental casting investment, dental brazing investment, dental pressable-ceramic investment and dental refractory die materials used in the dental laboratory, regardless of the composition of the refractory powder, the composition of the binder, or the particular application. ISO 15912:2016 classifies such products into types and classes, according to their intended use and the burn-out procedure recommended by the manufacturer. It also gives requirements for marking, labelling and manufacturer's instructions. It specifies requirements for the essential physical and mechanical properties of the products and the test methods to be used for determining them. NOTE 1 Compliance with all of the requirements presented in Clause 5 may not be necessary for some products, and a requirement might not be applicable to a product with a particular binder chemistry or be intended for an application in which that requirement is irrelevant. When this is the case, a clear statement to this effect is given according to Clause 5. NOTE 2 A specific quantitative requirement for setting expansion is not included in this International Standard. If the setting expansion of gypsum-bonded investment is measured, then the procedure given in ISO 6873[1] can be considered ? a procedure not recommended, however, for investment materials with other binders.

ISO 6872:2015 specifies the requirements and the corresponding test methods for dental ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses.

ISO 6873:2013 gives a classification of, and specifies requirements for, gypsum products used for dental purposes such as making oral impressions, moulds, casts, dies or model bases, and mounting models. It specifies the test methods to be employed to determine compliance with these requirements. It also includes requirements for the labelling of packaging and for adequate instructions to accompany each package.

ISO 20795-1:2013 classifies denture base polymers and copolymers and specifies their requirements. It also specifies the test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Furthermore, it applies to denture base polymers for which the manufacturer claims that the material has improved impact resistance. It also specifies the respective requirement and the test method to be used. ISO 20795-1:2013 applies to denture base polymers such as those listed below: poly(acrylic acid esters); poly(substituted acrylic acid esters); poly(vinyl esters); polystyrene; rubber modified poly(methacrylic acid esters); polycarbonates; polysulfones; poly(dimethacrylic acid esters); polyacetals (polyoxymethylene); copolymers or mixtures of the polymers listed in 1 to 9.

ISO 20795-2:2013 is applicable to orthodontic base polymers and copolymers used in the construction of both active and passive orthodontic appliances and specifies their requirements. It also specifies test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials.

ISO 13078:2013 specifies a test method for the calibration of dental furnaces that are suitable for the heat treatment of silica-based dental ceramic restorations in the temperature range between 600 °C and 1 050 °C.

ISO/TR 14569-1:2007 provides guidelines for test methods for the assessment of resistance to wear by tooth brushing for the following materials: materials used for the preparation of artificial teeth; veneering of crowns and bridges.

ISO 9333:2006 specifies requirements and test methods for brazing materials suitable for use in metallic restorations.

ISO 14233:2003 gives compositional, performance, user-information, packaging and marking, and testing requirements for polymer-based die materials used in dentistry. It is applicable to die materials having a polymeric matrix as their principal constituent. Polymer-based die materials are used in the dental laboratory mainly to produce casts from dental impressions for the manufacture of fixed or removable restorations)

ISO 14356:2002 specifies requirements and tests for the duplicating materials used in dentistry which are primarily intended for forming flexible moulds needed to produce positive refractory investment copies of properly blocked-out master models.

This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements. This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.

ISO 9693-2:2016 specifies requirements and test methods to assess the compatibility of ceramic-ceramic materials used for dental restorations by testing composite structures. The requirements of this part of ISO 9693 apply when different ceramic components are used in combination. Compliance cannot be claimed for either ceramic alone. For requirements of ceramic materials, see ISO 6872.

ISO 4823:2015 specifies the requirements and tests that the state-of-the art body of knowledge suggests for helping determine whether the elastomeric impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. NOTE This International Standard does not address possible biological hazards associated with the materials. Therefore, interested parties are encouraged to explore ISO 7405 and ISO 10993 for assessment of such hazards.

ISO 21563:2013 specifies the requirements and tests for helping determine whether the elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use.

ISO 13017:2012 specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of crowns and bridges, removable partial dentures, overdentures, superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.

ISO 9693-1:2012 specifies test methods for determining the compatibility of metallic and ceramic materials used for dental restorations by testing the composite structure. The requirements given in ISO 9693-1:2012 are applicable to metallic materials and ceramics when used in combination, and are not applicable to either metallic materials or ceramics when used alone.

ISO 10271:2011 provides test methods and procedures to determine the corrosion behaviour of metallic materials used in the oral cavity. It is intended that the test methods and procedures in ISO 10271:2011 be referred to in the individual International Standards specifying such metallic materials. ISO 10271:2011 is not applicable to instruments and dental amalgam and appliances for orthodontics.

ISO/TR 28642:2011 identifies three types of topics related to shade conformity and interconvertibility of monochromatic and polychromatic tissues and materials related to the discipline of dentistry; it describes visual and instrumental methods for assessment of these topics. ISO/TR 28642:2011 suggests interpretation of the findings through colour difference thresholds, and provides guidelines for future standardization related to dental shade conformity and interconvertibility. It also includes guidelines related to colour vision of persons undertaking visual colour assessment and instructions for reporting of colour and colour difference assessments.

ISO 28319:2010 specifies requirements and test methods for laser welding, in the dental laboratory, of materials suitable for use in metallic restorations and appliances.

ISO 20795-2:2010 is applicable to orthodontic base polymers and copolymers used in the construction of both active and passive orthodontic appliances and specifies their requirements. It also specifies test methods to be used in determining compliance with these requirements. ISO 20795-2:2010 further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials.

ISO 10139-2:2009 specifies requirements for softness, adhesion, water sorption and water solubility as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.

ISO 6872:2008 specifies the requirements and the corresponding test methods for dental ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses.

ISO 20795-1:2008 classifies denture base polymers and copolymers and specifies their requirements. It also specifies the test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Furthermore it applies to denture base polymers for which the manufacturer claims that the material has improved impact resistance. It also specifies the respective requirement and the test method to be used. ISO 20795-1:2008 applies to denture base polymers such as those listed below: poly(acrylic acid esters); poly(substituted acrylic acid esters); poly(vinyl esters); polystyrene; rubber modified poly(methacrylic acid esters); polycarbonates; polysulfones; poly(dimethacrylic acid esters); polyacetals (polyoxymethylene); copolymers or mixtures of the polymers listed above.

ISO 22674:2006 classifies metallic materials that are suitable for the fabrication of dental appliances and restorations, including metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses, and specifies their requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for the use of these materials.

ISO 15912:2006 is applicable to dental casting, brazing and refractory investments and refractory die materials, regardless of the nature of the binding system or the particular application. ISO 15912:2006 classifies investments into types according to their intended use and classes according to the burn-out procedure recommended by the manufacturer. ISO 15912:2006 specifies requirements for the essential physical and mechanical properties of the materials and the test methods used to determine them. ISO 15912:2006 also includes requirements for the information and instructions which accompany each package.

ISO 22112:2005 specifies the classification, requirements, and test methods for synthetic polymer and ceramic teeth that are manufactured for use in prostheses used in dentistry.

ISO 15854:2005 is applicable to dental casting wax and to dental baseplate wax. It specifies the classification of, and requirements for, dental casting wax and baseplate wax together with the test methods to be employed to determine compliance with these requirements.