ISO 24234:2021 PDF

Scope: 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.

ISO 24234:2021 Referenced Document

ISO 13897 Dentistry - Dental amalgam reusable mixing-capsules
ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 1942 Dentistry — Vocabulary — Amendment 1
ISO 23325 Dentistry — Corrosion resistance of dental amalgam
ISO 286-2 Geometrical product specifications (GPS) - ISO code system for tolerances on linear sizes - Part 2: Tables of standard tolerance classes and limit deviations for holes and shafts; Technical Corrigendum 1
ISO 3310-1 Test sieves - Technical requirements and testing - Part 1: Test sieves of metal wire cloth
ISO 3864-2 Graphical symbols - Safety colours and safety signs - Part 2: Design principles for product safety labels
ISO 4287 Geometrical product specifications (GPS) — Surface finish: Profile method — Surface finish terms, definitions and parameters — Amendment 2: .
ISO 7488 Dentistry - Mixing machines for dental amalgam

2021 ISO 24234:2021 Dentistry - Dental amalgam
2015 ISO 24234:2015 Dentistry - Dental amalgam
2011 ISO 24234:2004/Amd 1:2011 Dentistry - Mercury and alloys for dental amalgam - Amendment 1: Requirements for marking and manufacturer's instructions concerning mercury
2004 ISO 24234:2004 Dentistry - Mercury and alloys for dental amalgam