This document 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. This document 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. This document 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.
DIN EN ISO 20749:2018 Referenced Document
DIN EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
DIN EN ISO 13565-2:1998 Geometrical Product Specifications (GPS) - Surface texture: Profile method - Surfaces having stratified functional properties - Part 2: Height characterization using the linear material ratio curve (ISO 13565-2:1996); German version EN ISO 13565-2:1997
DIN EN ISO 13897:2018 Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018); German version EN ISO 13897:2018
DIN EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03); German version EN ISO 15223-1:2016, with CD-ROM
DIN EN ISO 1942:2011 Dentistry - Vocabulary (ISO 1942:2009, Corrected version 2010-03-01); German version EN ISO 1942:2010
DIN EN ISO 24234:2015 Dentistry - Dental amalgam (ISO 24234:2015); German version EN ISO 24234:2015
DIN EN ISO 286-2:2010 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 (ISO 286-2:2010); German version EN ISO 286-2:2010
DIN EN ISO 7405:2013 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008 + Amd. 1:2013); German version EN ISO 7405:2008 + A1:2013
DIN EN ISO 7488:2018 Dentistry - Mixing machines for dental amalgam (ISO 7488:2018); German version EN ISO 7488:2018
DIN ISO 3310-1:2017 Test sieves - Technical requirements and testing - Part 1: Test sieves of metal wire cloth (ISO 3310-1:2016)
DIN ISO 3864-2:2017 Graphical symbols - Safety colours and safety signs - Part 2: Design principles for product safety labels (ISO 3864-2:2016)
DIN ISO 6344-1:2000 Coated abrasives - Grain size analysis - Part 1: Grain size distribution test (ISO 6344-1:1998)
ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 13565-2:1996 Geometrical Product Specifications (GPS) - Surface texture: Profile method; Surfaces having stratified functional properties - Part 2: Height characterization using the linear material ratio curve
ISO 13897:2018 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 286-2:2010 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
ISO 3310-1:2016 Test sieves - Technical requirements and testing - Part 1: Test sieves of metal wire cloth
ISO 3864-2:2016 Graphical symbols - Safety colours and safety signs - Part 2: Design principles for product safety labels
ISO 6344-1:1998 Coated abrasives - Grain size analysis - Part 1: Grain size distribution test
ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 7488:2018 Dentistry - Mixing machines for dental amalgam
ISO/TS 17988:2014 Dentistry - Corrosion test methods for dental amalgam
DIN EN ISO 20749:2018 history
2023DIN EN ISO 20749:2023-10 Dentistry - Pre-capsulated dental amalgam (ISO 20749:2023); German version EN ISO 20749:2023
2023DIN EN ISO 20749:2023 Dentistry - Pre-capsulated dental amalgam (ISO 20749:2023)
2018DIN EN ISO 20749:2018-11 Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017); German version EN ISO 20749:2018 / Note: To be replaced by DIN EN ISO 20749 (2022-03).
2018DIN EN ISO 20749:2018 Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017); German version EN ISO 20749:2018
2017DIN EN ISO 20749 E:2017 Draft Document - Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017); German and English version prEN ISO 20749:2017
2015DIN EN ISO 24234:2015 Dentistry - Dental amalgam (ISO 24234:2015); German version EN ISO 24234:2015
0000 DIN EN ISO 24234:2013
2011DIN EN ISO 24234:2011 Dentistry - Mercury and alloys for dental amalgam (ISO 24234:2004 + Amd 1:2011); German version EN ISO 24234:2004 + A1:2011
0000 DIN EN ISO 24234/A1:2009
0000 DIN EN ISO 24234:2005
DIN EN ISO 20749:2018 Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017); German version EN ISO 20749:2018 has been changed from DIN EN ISO 24234:2015 Dentistry - Dental amalgam (ISO 24234:2015); German version EN ISO 24234:2015.