UNE-EN ISO 20749:2019

This document specifies the requirements and test methods for dental amalgam products supplied tothe user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable forthe creation of a single dental restoration.This document specifies the requirements and test methods for dental amalgam alloys that are suitablefor the preparation of dental amalgam and the capsule, together with the requirements and testmethods for that dental amalgam and the requirements for packaging and marking.This document is not applicable to dental amalgam alloys supplied as a free-flowing powder in bulkquantities or as powder compressed into tablets, or to dental mercury supplied in sachets or bulkquantities.This document is not applicable to other metallic materials in which an alloy powder reacts with analloy that is liquid at ambient temperature to produce a solid metallic material intended for dentalrestoration.Specific qualitative and quantitative test methods for demonstrating freedom from unacceptablebiological 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-capsulatedform alone. Other products intended for use in the production of dental amalgam restorations (dentalamalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder suppliedas compressed tablets and dental mercury sachets) are within the scope of ISO 24234.