Dentistry - Dental amalgam
|Publication Date:||1 May 2015|
|ICS Code (Dental materials):||11.060.10|
This International Standard 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).
With respect to dental mercury, the scope is limited solely to dental mercury which is supplied precapsulated or in pre-dosed sachets. Both are limited to a mass sufficient for one mix. The mass of dental mercury in one capsule or sachet shall be sufficient to produce a homogeneous plastic mix, appropriate for a small or medium sized restoration in a single tooth. This International Standard is not applicable to mercury supplied in masses greater than this in a single primary container (i.e. dental mercury in bulk). Dental mercury supplied in bulk volumes will not conform to this International Standard.
This International Standard does not exclude the supply of dental amalgam alloy or dental mercury separately.
This International Standard is not applicable to 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.
NOTE Dental mercury is at least 99,99 % pure, and as such, it is a metallic element of high commercial purity, and not an alloy