ISO/TC 106/SC 1/WG 10 - Dental luting cements, bases and liners
Ciments dentaires pour scellements, fonds et revêtements de cavités
General Information
ISO 9917-2:2017 specifies requirements and test methods for water-based dental cements in which setting is achieved by a combination of an acid-base reaction and polymerization. The materials are intended for luting, base or lining, restoration and tooth core build up purposes. EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of this document will normally be able to effect setting by such an aqueous acid-base type reaction but in addition will be able to undergo setting by polymerization. NOTE The attention of manufacturers and test laboratories is drawn to the closely-related International Standards ISO 4049 and ISO 9917‑1 so that they can consider which is the most appropriate for evaluating any individual product.
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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.
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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.
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ISO 3107:2004 specifies the requirements and performance test methods for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for permanent cementation, for cavity liners and bases and as temporary restorations. ISO 3107:2004 is also applicable to non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation.
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ISO 9917-1:2003 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. It is applicable to both hand-mixed cements and encapsulated cements for mechanical mixing. It specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, a restorative material, a base or a liner. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of ISO 9917, but it is recommended that, in assessing possible biological or toxicological hazards, reference should be made to ISO 7405, Dentistry -- Preclinical evaluation of biocompatibility of medical deviced used in dentistry -- Test methods for dental materials, and ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing.
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Specifies requirements for dental cements as follows: silicate cements, zinc phosphate cements, silicophosphate cements, zinc polycarbonate cements and glass polyalkenoate cements.
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Cancels and replaces ISO 3106/74 and ISO 3107/74. It specifies requirements and test methods for cements delivered as separate components and used in restorative dentistry for temporary and permanent cementation. Specific qualitative or quantitative requirements for freedom from biological or toxicological hazards are not included.
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