EN ISO 20749:2023
(Main)Dentistry - Pre-capsulated dental amalgam (ISO 20749:2023)
Dentistry - Pre-capsulated dental amalgam (ISO 20749:2023)
This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy powder and dental mercury in quantities suitable for the creation of a single dental restoration.
This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking.
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 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 described in ISO 24234.
Zahnheilkunde - Dentalamalgam in Kapseln (ISO 20749:2023)
Dieses Dokument legt die Anforderungen und Prüfverfahren für Dentalamalgamprodukte fest, das an den Anwender in Kapseln, vordosiert mit dentalem Amalgamlegierungspulver und dentalem Quecksilber in Mengen, die zur Herstellung einer einzelnen dentalen Restauration geeignet ist, ausgeliefert wird.
Dieses Dokument legt die Anforderungen und Prüfverfahren für die Kapsel sowie die Anforderungen an die Verpackung und Kennzeichnung fest.
Dieses Dokument ist nicht anwendbar für andere metallische Werkstoffe, bei denen ein Legierungspulver mit einer Legierung, die bei Umgebungstemperatur flüssig ist, reagiert, um einen festen metallischen Werkstoff herzustellen, der für dentale Restaurationen vorgesehen ist.
Dieses Dokument beschränkt sich auf Dentalamalgamprodukte, die ausschließlich in vorgekapselter Form vermarktet werden. Andere Produkte, die für die Herstellung von dentalen Amalgamrestaurationen bestimmt sind (dentale Amalgamlegierung als frei fließendes Pulver, das in großen Mengen geliefert wird, dentales Amalgamlegierungspulver, das in Form von gepressten Tabletten geliefert wird, und dentale Quecksilberbeutel), sind in ISO 24234 beschrieben.
Médecine bucco-dentaire - Amalgame dentaire en capsules prédosées (ISO 20749:2023)
Le présent document spécifie les exigences et les méthodes d’essai applicables aux amalgames dentaires fournis à l’utilisateur sous forme de capsules, prédosées avec la poudre d’alliage pour amalgame dentaire et le mercure à usage dentaire dans des quantités appropriées pour créer une seule restauration dentaire.
Le présent document spécifie les exigences et les méthodes d'essai applicables à la capsule, et les exigences d'emballage et de marquage.
Le présent document n’est pas applicable à d’autres matériaux métalliques dans lesquels une poudre d’alliage réagit avec un alliage liquide à température ambiante pour produire un matériau métallique solide destiné à la restauration dentaire.
Le présent document est limité aux amalgames dentaires commercialisés sous forme de capsules prédosées uniquement. Les autres produits destinés à être utilisés lors de la production de matériaux de restauration des amalgames dentaires (alliages d’amalgame dentaire sous forme de poudre fluide en vrac, poudre d’alliage pour amalgame dentaire sous forme de tablettes comprimées et sachets de mercure à usage dentaire) sont décrits dans l’ISO 24234.
Zobozdravstvo - Pripravljeni zobni amalgam (ISO 20749:2023)
Zobna amalgamska zlitina in živo srebro sta bistveni in edini sestavini materiala za obnovo zob iz zobnega amalgama. Ta dokument določa zahteve in preskusne metode za zobozdravstvene izdelke iz pripravljenega zobnega amalgama z vnaprej dodanimi količinami zobne amalgamske zlitine in živega srebra, ki so primerne za popravilo enega zoba.
Ta dokument določa zahteve in preskusne metode za pripravljeni zobni amalgam ter zahteve za embalažo in označevanje.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2023
Nadomešča:
SIST EN ISO 20749:2018
Zobozdravstvo - Pripravljeni zobni amalgam (ISO 20749:2023)
Dentistry - Pre-capsulated dental amalgam (ISO 20749:2023)
Zahnheilkunde – Dentalamalgam in Kapseln (ISO 20749:2023)
Médecine bucco-dentaire - Amalgame dentaire en capsules prédosées (ISO
20749:2023)
Ta slovenski standard je istoveten z: EN ISO 20749:2023
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 20749
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 20749:2018
English Version
Dentistry - Pre-capsulated dental amalgam (ISO
20749:2023)
Médecine bucco-dentaire - Amalgame dentaire en Zahnheilkunde - Dentalamalgam in Kapseln (ISO
capsules prédosées (ISO 20749:2023) 20749:2023)
This European Standard was approved by CEN on 13 March 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20749:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 20749:2023) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 20749:2018.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 20749:2023 has been approved by CEN as EN ISO 20749:2023 without any modification.
INTERNATIONAL ISO
STANDARD 20749
Second edition
2023-06
Dentistry — Pre-capsulated dental
amalgam
Médecine bucco-dentaire — Amalgame dentaire en capsules
prédosées
Reference number
ISO 20749:2023(E)
ISO 20749:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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Published in Switzerland
ii
ISO 20749:2023(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 Package and capsule contamination . 3
4.2 Chemical composition and purity of the dental amalgam alloy . 3
4.3 Large particles in the dental amalgam alloy powder . 3
4.4 Loss of mass from the capsule during mixing . 3
4.5 Yield of dental amalgam from the capsule . . 3
4.6 Consistency of the dental amalgam from capsule to capsule . 4
4.7 Properties of the dental amalgam . 4
4.7.1 General . 4
4.7.2 Creep . 4
4.7.3 Dimensional changes during hardening . 4
4.7.4 Compressive fracture stress at 2 h . 4
4.7.5 Compressive fracture stress at 24 h . 4
4.8 Appearance of mixed dental amalgam before setting . 5
4.9 Corrosion resistance of the dental amalgam . 5
4.10 Length tolerance for the capsule . 5
5 Sampling . 5
6 Test methods . 5
6.1 Package and capsule contamination . 5
6.1.1 Principle . 5
6.1.2 Test sample . 5
6.1.3 Apparatus . 5
6.1.4 Procedure . 5
6.1.5 Treatment of the results . 6
6.1.6 Report. 6
6.2 Chemical composition and purity of the dental amalgam alloy . 6
6.2.1 Principle . 6
6.2.2 Test sample . 6
6.2.3 Apparatus . 6
6.2.4 Procedure . 7
6.2.5 Treatment of the results . 7
6.2.6 Report. 7
6.3 Large particles in the dental amalgam alloy powder . 8
6.3.1 Principle . 8
6.3.2 Test sample . 8
6.3.3 Apparatus . 8
6.3.4 Procedure . 8
6.3.5 Treatment of the results . 8
6.3.6 Report. 8
6.4 Loss of mass from the capsule during mixing . 9
6.4.1 Principle . 9
6.4.2 Test sample . 9
6.4.3 Apparatus . 9
6.4.4 Test procedure. 9
6.4.5 Treat
...
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