ISO 20749:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Dentistry — Pre-capsulated dental amalgam
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
30-06-2023
English, French
17-03-2017
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ISO 20749:2017 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.
ISO 20749:2017 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.
ISO 20749:2017 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.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological 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-capsulated form alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are within the scope of ISO 24234.
| Committee |
ISO/TC 106/SC 1
|
| DevelopmentNote |
Supersedes ISO/DIS 20749. (03/2017)
|
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| DS/EN ISO 20749 : 2018 | Identical |
| SS-EN ISO 20749 : 2018 | Identical |
| NF ISO 20749 : 2017 | Identical |
| SN EN ISO 20749:2019 | Identical |
| UNI EN ISO 20749:2018 | Identical |
| UNE-EN ISO 20749:2019 | Identical |
| EN ISO 20749:2018 | Identical |
| BS ISO 20749 : 2017 | Identical |
| NEN-EN-ISO 20749:2018 en | Identical |
| DIN EN ISO 20749:2018-11 | Identical |
| PN-EN ISO 20749:2018-12 | Identical |
| ÖNORM EN ISO 20749 : 2018 | Identical |
| BS EN ISO 20749:2018 | Identical |
| ISO 13897:2018 | Dentistry — Dental amalgam reusable mixing-capsules |
| 17/30323658 DC : 0 | BS EN ISO 7488 - MIXING MACHINES FOR DENTAL AMALGAM |
| I.S. EN ISO 13897:2018 | DENTISTRY - DENTAL AMALGAM REUSABLE MIXING-CAPSULES (ISO 13897:2018) |
| EN ISO 13897:2018 | Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018) |
| ISO 3310-1:2016 | Test sieves Technical requirements and testing Part 1: Test sieves of metal wire cloth |
| ISO 24234:2015 | Dentistry Dental amalgam |
| ISO 3864-2:2016 | Graphical symbols — Safety colours and safety signs — Part 2: Design principles for product safety labels |
| ISO/TS 17988:2014 | Dentistry Corrosion test methods for dental amalgam |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| ISO 1942:2009 | Dentistry Vocabulary |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| 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 6344-1:1998 | Coated abrasives Grain size analysis Part 1: Grain size distribution test |
| 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 7488:1991 | Dental amalgamators |
| ISO 13897:2003 | Dentistry Amalgam capsules |
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