ISO/TC 106/SC 1/WG 7 - Dental amalgam

This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy powder and dental mercury in quantities suitable for the creation of a single dental restoration. This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking. This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration. This document is restricted to dental amalgam products marketed in pre-capsulated form, alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are described in ISO 24234.

This document specifies the requirements and test methods for dental amalgam alloy powder and dental mercury 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. NOTE Two of the requirements apply only to dental mercury (as supplied). All of the other requirements apply to the dental amalgam alloy (as supplied) and dental amalgam. This document is not applicable to dental amalgam alloy powder and dental mercury supplied in a pre-capsulated form. This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration. This document applies to products used to make dental amalgam restorations, supplied to the user in the following forms: dental amalgam alloy as a fine free flowing powder, or as a fine powder compacted into tablets and dental mercury in dental mercury sachets (sometimes referred to as dental mercury pillows). The mass of dental mercury in these sachets is limited to the amount required to make a small to medium-sized restoration in a single tooth. This document is not applicable to dental mercury that is supplied in a primary container in an undivided mass that exceeds the amount suitable for a small to medium-sized restoration.

This document specifies the requirements for the permissible reduction in strength resulting from crevice corrosion of dental amalgam products that are within the scope of ISO 24234 or ISO 20749. It provides details of the test procedure for determining this.

This document gives the details of test procedures for evaluating the corrosion resistance of dental amalgam formed from products that are within the scopes of ISO 24234 and ISO 20749. This document is not applicable to other metallic materials in which an alloy powder reacts with a liquid alloy to produce a solid metallic material intended for dental restoration.

ISO/TS 20746:2016 gives the practical details of the test method for the measurement of the strength of a dental amalgam by the Hertzian indentation strength test (HIT) method. It is applicable to dental amalgam formed from products that are within the scope of ISO 24234 and ISO 20749.

ISO 20749:2017 specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable for the creation of a single dental restoration. ISO 20749:2017 specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam and the capsule, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking. ISO 20749:2017 is not applicable to dental amalgam alloys supplied as a free-flowing powder in bulk quantities or as powder compressed into tablets, or to dental mercury supplied in sachets or bulk quantities. This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration. Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this document. For the assessment of possible biological hazards, reference can be made to ISO 10993‑1 and ISO 7405. The scope of this document is restricted to dental amalgam products marketed in pre-capsulated form alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are within the scope of ISO 24234.

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).

ISO 24234:2004 specifies the requirements and test methods for alloys and for mercury suitable for the preparation of dental amalgam, together with the requirements and test methods for that amalgam and the requirements for packaging and marking. It is applicable to alloys supplied in the form of either a powder in bulk, or a powder compressed to form a tablet, or a powder in predosed capsules. It is applicable to dental mercury supplied either in bulk quantities, or in predosed sachets, or in predosed capsules. ISO 24234:2004 does not exclude the supply of alloy or mercury separately. ISO 24234:2004 is not applicable to alloys intended for use with liquid metals that are not mercury, nor is it applicable to liquid metal alloys.

ISO/TS 17576:2004 provides two test methods and concomitant protocols to determine the corrosive behaviour of dental amalgams and their tendency to release mercury vapour during corrosion. The methods measure 1) the integrated current in a potentiostatic corrosion test and 2) the amount of released ions and mercury vapour in a static immersion test. ISO/TS 17576:2004 is not intended to set limits for the relevant parameters in the two tests described.

Specifies requirements and test methods for alloys composed mainly of silver, tin and copper. The alloy may be in either powder or tablet form, or in capsules with portions of alloy and mercury predosed by the manufacturer, suitable for the preparation of dental amalgam. Replaces the second edition, of which it constitutes a technical revision.

Specification of requirements and test methods for mercury suitable for the preparation of dental amalgam, together with requirements for packaging and marketing. This standard does not specify neither the requirements for sampling and the method of procurement nor the amount of mercury needed for testing.