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||Materials and amalgams used in dentistry adhere to requirements to assure compatibility with both the human body and the equipment used to manipulate them. These standards provide guidance on testing wear, adhesion, compatibility, and corrosion, as well as setting out requirements and test methods for materials. Packaging and marking requirements are also included, to provide consistency and reliability in the use of dental materials.|
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Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
ISO 3107:2011 specifies requirements for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations. ISO 3107:2011 also specifies requirements for non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation.
Dentistry - Polymer-based restorative materials
ISO 4049:2009 specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth and for luting. The polymer-based luting materials covered by ISO 4049:2009 are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This International Standard does not cover those polymer-based luting materials that have an adhesive component within the structure of the material.
Dentistry - Elastomeric impression materials
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.
Dentistry - Ceramic materials
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.
Dentistry - Polymer-based pit and fissure sealants
ISO 6874:2015 specifies requirements and test methods for polymer-based materials intended for sealing pits and fissures in teeth. It covers both self-curing and external-energy-activated materials.
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 7405:2008 specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
This International Standard specifies requirements, test methods to determine compliance with these powered mixing amalgamators suitable for mixing dental amalgam alloy and mercury for dental amalgams. It provides methods of comparing uniformity of operation and performance of these amalgamators and is intended to ensure reproducibility of amalgamation.
Dental materials -- Determination of colour stability
This International Standard specifies a method for the determination of the colour stability of dental materials after exposure to light and water.
Dental equipment -- Mercury and alloy mixers and dispensers
Specifies requirements and test methods for devices used for dispensing dental amalgam alloys and/or mercury. Includes the dispensing portion of devices which dispense the correct portions of alloy and mercury as well as mix the amalgam in a single, continuous operation. Does not specify requirements and test methods for the efficacy of mixing.
Dentistry - Brazing materials
ISO 9333:2006 specifies requirements and test methods for brazing materials suitable for use in metallic restorations.
Dentistry - Compatibility testing - Part 1: Metal-ceramic systems
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.
Dentistry - Compatibility testing - Part 2: Ceramic-ceramic systems
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.
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
ISO 9917-1:2007 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. ISO 9917-1:2007 is applicable to both hand-mixed and capsulated cements for mechanical mixing. ISO 9917-1:2007 specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, a base or liner or as a restorative material. ISO 9917-1:2007 is not intended to address resin-modified water-based cements.
Dentistry - Water-based cements - Part 2: Resin-modified cements
ISO 9917 2:2010 specifies requirements and test methods for dental cements that are intended for luting, base or lining and restoration purposes and for which the materials are water-based and set by multiple reactions in which setting is achieved by a combination of an acid-base reaction and polymerization.
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
ISO 10139-1:2005 specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for denture lining materials suitable for short-term use.
This standard is also available from:
ISO Corrigendum 2006 /
DIN Corrigendum 2006 /
ON 2006 /
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
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.
Dentistry - Corrosion test methods for metallic materials
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.
Dentistry - Polymer-based crown and bridge materials
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.
Dentistry - Denture adhesives
ISO 10873:2010 classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. ISO 10873:2010 is applicable to denture adhesives for use by the public and excludes the dental lining materials prescribed or applied by dental professionals. ISO 10873:2010 does not specify qualitative or quantitative requirements for freedom from biological hazards. For assessing possible biological hazards, see ISO 7405 and ISO 10993-1.
Dentistry - Amalgam separators
ISO 11143:2008 specifies requirements and test methods for amalgam separators used in connection with dental equipment in the dental treatment centre. It specifies the efficiency of the amalgam separators in terms of the level of retention of amalgam based on a laboratory test and the test procedure for determining this efficiency. It also includes requirements for the safe functioning of the amalgam separator, for marking, instructions for use, operation and maintenance. All tests described in ISO 11143:2008 are type tests.
Dentistry - Testing of adhesion to tooth structure
ISO/TS 11405:2015 gives guidance on substrate selection, storage, and handling as well as essential characteristics of different test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure, i.e. enamel and dentine. It includes a tensile bond strength measurement test, a test for measurement of marginal gaps around fillings, a microleakage test, and gives guidance on clinical usage tests for such materials. Some specific test methods for bond strength measurements are given for information in Annex A. ISO/TS 11405:2015 does not include requirements for adhesive materials and their performance.
Dentistry - Test Method for Determining Radio-Opacity of Materials
Dentistry - Amalgam capsules
ISO 13897:2003 specifies requirements and test methods for predosed capsules and for reusable capsules used for mixing dental amalgam alloys and mercury.
Dentistry - Polymer-based die materials
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)
Dentistry - Duplicating material
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.
Dental materials - Guidance on testing of wear - Part 1: Wear by toothbrushing
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.
Dental materials - Guidance on testing of wear - Part 2: Wear by two- and/or three body contact
This part of ISO/TS 14569 specifies test methods for the assessment of resistance to wear of materials occurring on the occlusal surfaces of restorations, in or on natural teeth or on artificial teeth, as a result of physiological activity in the mouth. Some of the proposed methods include wear from foodstuff as well as, or only, wear by direct contact. The test methods shown in Table 1 are described. This part of ISO/TS 14569 is not applicable to phenomena such as the marginal degradation and loss of substance by chemical processes, swelling, splintering of edges, or wear from toothbrushing.
Dentistry - Casting and baseplate waxes
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.
Dentistry - Refractory investment and die material
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 can be considered ? a procedure not recommended, however, for investment materials with other binders.
Dentistry - Polymerization shrinkage: Method for determination of polymerization shrinkage of polymer-based restorative materials
ISO 17304:2013 specifies a test method for the measurement of the polymerization shrinkage of external energy-activated polymer-based restorative materials such as composites and core materials.
Dentistry - Corrosion test methods for dental amalgam
ISO/TS 17988:2014 gives details of test procedures for evaluating the corrosion resistance of dental amalgam produced from a dental amalgam alloy product. It is applicable to dental amalgam formed from products that are within the scope of ISO 24234 .
Dentistry - Base polymers - Part 1: Denture base polymers
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.
Dentistry - Base polymers - Part 2: Orthodontic base polymers
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.
Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants
ISO 21530:2004 specifies test methods for determining the resistance to chemical disinfectants of all materials used for external surfaces of dental equipment intended for such disinfection. Three test methods are specified: an immersion test, a spray test and a contact test. The choice of test method to be used is left to the discretion of the party conducting the testing. ISO 21530:2004 does not address the bactericidal, virucidal and fungicidal effectivity of the disinfectants. ISO 21530:2004 does not provide for testing the possible detrimental effects of applied stress on the resistance of test materials to the test reagents.
Dentistry - Hydrocolloid impression materials
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.
Dentistry - Metallic materials for fixed and removable restorations and appliances
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).
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
ISO 22794:2007 applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (greater than 90 %) hydroxyapatite are not covered by this International Standard. Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials.
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
ISO 22803:2004 gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality, b) in contact with teeth and/or dental implants, c) for prevention of epithelial migration in periodontal surgery, d) for the augmentation of bone prior to the planned insertion of dental implants, e) and/or for augmentation of bone for stabilization of dental prostheses. This International Standard is not applicable to materials whose primary intended use is to deliver a medicinal product, autografts and allografts, or materials intended to act through pharmacological, immunological or metabolic means.
Dentistry - Dental amalgam
ISO 24234:2015 specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking (including those for dental mercury). It is applicable to dental amalgam alloys supplied in the form of a free-flowing powder in bulk, or a powder compressed to form a tablet, or a powder in a capsule (i.e. pre-capsulated).
Dentistry - Adhesion - Notched-edge shear bond strength test
ISO 29022:2013 specifies a shear test method used to determine the adhesive bond strength between direct dental restorative materials and tooth structure, e.g. dentine or enamel. The method as described is principally intended for dental adhesives. The method includes substrate selection, storage and handling of tooth structure, as well as the procedure for testing.