This International Standard specifies requirements and test methods for dental amalgam alloys suitable for the manufacture of dental amalgam, together with requirements and test methods for such dental amalgams and requirements for packaging and labeling (including those for dental mercury). It applies to dental amalgam alloys supplied in the form of free-flowing loose powder, or as powder pressed into tablet form, or as powder in a capsule (ie pre-dosed capsule). With regard to dental mercury, the scope of application is limited to dental mercury supplied in pre-dosed capsules or in pre-dosed sachets. Both delivery forms are limited to a mass that is sufficient for a mixture. The mass of dental mercury in a capsule or bag must be sufficient to produce a homogeneous plastic mixture sufficient for a small or medium-sized restoration in a single tooth. This International Standard does not apply to mercury supplied in quantities greater than a single primary container (ie dental mercury in bulk form). Dental mercury supplied in loose form does not comply with this International Standard. This International Standard does not exclude the separate supply of dental amalgam alloys or dental mercury. This International Standard does not apply to metallic alloys in which an alloy powder reacts with an alloy that is liquid at ambient temperatures to thereby produce a solid metallic material intended for dental restorations. NOTE Dental mercury is at least 99.99% pure and, as such, is a metallic element of high commercial purity and is not an alloy.
EN ISO 24234:2015 Referenced Document
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