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ILNAS-EN ISO 20749:2018 Edition 09/2018
Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017)
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Abstract

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.

Status

Standard - Superseded

Origin

Technical Committee :
CEN/TC 55 : Dentistry

Implementation

start of the vote on the project    24/08/2017   date of ratification (dor)    22/07/2018
end of the vote on the project    16/11/2017   date of anouncement (doa)    31/12/2018
start of the vote on the final project    26/04/2018   date of publication (dop)    31/03/2019
end of the vote on the final project    21/06/2018   date of withdrawal (dow)    31/03/2019


Publication Official Journal
of the Grand-Duchy of Luxembourg
06/11/2018
Reference Mémorial A N° 1003

Relations

Evolutions
ILNAS-EN ISO 20749:2023

Relations to older standards
ILNAS-EN ISO 24234:2015

International Classification for Standards (ICS codes) :

11.060.10 : Dental materials

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