EN ISO 20749:2018

Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017)

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.

Zahnheilkunde - Gekapseltes zahnärztliches Amalgam (ISO 20749:2017)

Dieses Dokument legt die Anforderungen und Prüfverfahren für zahnärztliches Amalgam fest, das dem Anwender in vordosierten Kapseln in einer Menge ausgeliefert wird, mit der die zahnärztliche Amalgam¬legierung und das dentales Quecksilber zur Herstellung einer einzelnen dentalen Restauration geeignet ist.
Dieses Dokument legt Anforderungen an und Prüfverfahren für zahnärztliche Amalgamlegierungen, die zur Herstellung von zahnärztlichem Amalgam und der Kapsel geeignet sind fest, zusammen mit Anforderungen an und Prüfverfahren für diese dentalen Amalgame und Anforderungen an Verpackung und Kennzeichnung.
Dieses Dokument gilt nicht für zahnärztliche Amalgamlegierungen, die als frei fließendes loses Pulver oder als in Tablettenform gepresstes Pulver ausgeliefert werden und nicht für dentales Quecksilber, das in Beuteln oder lose ausgeliefert wird.
Dieses Dokument gilt nicht für andere metallische Legierungen, bei denen ein Legierungspulver mit einer Legierung reagiert, die bei Umgebungstemperaturen flüssig ist, um dadurch ein festes metallisches Material herzustellen, das für dentale Restaurationen vorgesehen ist.
Dieses Dokument enthält keine besonderen qualitativen und quantitativen Prüfverfahren zum Ausschluss nicht zulässiger biologischer Risiken. Zur Beurteilung möglicher biologischer Risiken wird empfohlen, ISO 10993 1 und ISO 7405 heranzuziehen.
Der Anwendungsbereich dieses Dokuments ist ausschließlich auf zahnärztliche Amalgame beschränkt, die in vordosierten Kapseln vertrieben werden. Andere Produkte für die Verwendung bei der Herstellung von dentalen Amalgamrestaurationen (zahnärztliches Amalgam als frei fließendes loses Pulver, zahnärztliches Amalgamlegierungspulver in Tablettenform gepresst und dentale Quecksilberbeutel) liegen im Anwen¬dungsbereich von ISO 24234.

Médecine bucco-dentaire - Amalgame dentaire en capsules prédosées (ISO 20749:2017)

L'ISO 20749:2017 spécifie les exigences et les méthodes d'essai applicables aux amalgames dentaires fournis à l'utilisateur sous forme de capsules, prédosées avec l'alliage pour amalgame dentaire et le mercure à usage dentaire dans des quantités appropriées pour créer une seule restauration dentaire.
L'ISO 20749:2017 spécifie les exigences et les méthodes d'essai applicables aux alliages pour amalgame dentaire utilisés dans la préparation des amalgames dentaires et des capsules, les exigences et les méthodes d'essai relatives à ces amalgames dentaires et les exigences d'emballage et de marquage.
L'ISO 20749:2017 n'est applicable ni aux alliages pour amalgame dentaire fournis sous forme de poudre fluide en vrac ou de poudre sous forme de comprimés ni au mercure à usage dentaire fourni sous forme de sachets ou en vrac.
L'ISO 20749:2017 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.
L'ISO 20749:2017 ne comporte aucune méthode d'essai qualitative et quantitative spécifique démontrant l'absence de dangers biologiques inacceptables. Pour évaluer la possibilité de tels dangers, il est possible de se référer à l'ISO 10993‑1 et à l'ISO 7405.
Le domaine d'application de l'ISO 20749:2017 est limité aux amalgames dentaires commercialisés sous forme de capsules prédosées uniquement. Les autres produits destinés à être utilisés pour la production de restaurations en amalgame dentaire (alliage d'amalgame dentaire sous forme de poudre fluide en vrac, poudre d'alliage pour amalgame dentaire sous forme de comprimés et sachets de mercure à usage dentaire) font partie du domaine d'application de l'ISO 24234.

Zobozdravstvo - Pripravljeni zobni amalgam (ISO 20749:2017)

Standard ISO 20749:2017 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.
ISO 20749:2017 določa zahteve in preskusne metode za zlitine zobnega amalgama, ki so primerne za izdelavo pripravljenega zobnega amalgama, skupaj z zahtevami in preskusnimi metodami za ta zobni amalgam ter zahtevami za pakiranje in označevanje.
ISO 20749:2017 se ne uporablja za zlitine zobnega amalgama, ki so dobavljene v večjih količinah kot sipki prah, kot prah, stisnjen v tablete ali kot zobno živo srebro, dobavljeno v vrečkah ali večjih količinah.
Ta dokument se ne uporablja za druge kovinske materiale, pri katerih zlitina prahu reagira z zlitino, ki je tekoča pri sobni temperaturi, pri čemer nastane trden kovinski material za popravilo zob.
Ta dokument ne zajema posebnih kvalitativnih in kvantitativnih preskusnih metod za dokazovanje neprisotnosti nesprejemljivih bioloških tveganj. Za oceno bioloških tveganj se lahko sklicuje na standarda ISO 10993‑1 in ISO 7405.
Področje uporabe tega dokumenta je omejeno na izdelke iz zobnega amalgama, ki se tržijo kot pripravljeni zobni amalgam. Drugi izdelki, ki so namenjeni popravilu zob s pomočjo amalgama (zlitina zobnega amalgama v obliki sipkega prahu, dobavljenega v večjih količinah, prah zlitine zobnega amalgama, dobavljen v obliki tablet in zobno živo srebro, dobavljeno v vrečkah) spadajo na področje uporabe standarda ISO 24234.

General Information

• Status: Withdrawn
• Publication Date: 04-Sep-2018
• Withdrawal Date: 11-Jul-2023
• ICS: 11.060.10 - Dental materials
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 20749:2018 - Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017)

Relations

• Replaces: EN ISO 24234:2015 - Dentistry - Dental amalgam (ISO 24234:2015)
• Effective Date: 12-Sep-2018
• Replaced By: EN ISO 20749:2023 - Dentistry - Pre-capsulated dental amalgam (ISO 20749:2023)
• Effective Date: 22-Sep-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2018
1DGRPHãþD
SIST EN ISO 24234:2015
Zobozdravstvo - Pripravljeni zobni amalgam (ISO 20749:2017)
Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017)
Zahnheilkunde - Vorgefertigte Amalgamkapseln (ISO 20749:2017)
Médecine bucco-dentaire - Amalgame dentaire en capsules prédosées (ISO
20749:2017)
Ta slovenski standard je istoveten z: EN ISO 20749:2018
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20749
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2018
EUROPÄISCHE NORM
ICS 11.060.10
English Version
Dentistry - Pre-capsulated dental amalgam (ISO
20749:2017)
Médecine bucco-dentaire - Amalgame dentaire en Zahnheilkunde - Gekapseltes zahnärztliches Amalgam
capsules prédosées (ISO 20749:2017) (ISO 20749:2017)
This European Standard was approved by CEN on 22 July 2018.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20749:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 20749:2017 has been prepared by Technical Committee ISO/TC 106 "Dentistry” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 20749:2018 by
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 March 2019, and conflicting national standards shall
be withdrawn at the latest by March 2019.
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.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 20749:2017 has been approved by CEN as EN ISO 20749:2018 without any modification.

INTERNATIONAL ISO
STANDARD 20749
First edition
2017-03
Dentistry — Pre-capsulated dental
amalgam
Médecine bucco-dentaire — Amalgame dentaire en capsules
prédosées
Reference number
ISO 20749:2017(E)
©
ISO 2017
ISO 20749:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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 the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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ii © ISO 2017 – All rights reserved

ISO 20749:2017(E)
Contents Page
Foreword .v
Introduction .vi
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 The yield of 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 Creep . 4
4.7.2 Dimensional changes during hardening . 4
4.7.3 Compressive strength at 1 h . 4
4.7.4 Compressive strength at 24 h . 4
4.8 Appearance of the mixed dental amalgam before setting . 4
4.9 Length tolerance for the capsule . 4
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 Expression of the results . 5
6.1.6 Report . 5
6.2 Chemical composition and purity of the dental amalgam alloy . 5
6.2.1 Principle . 5
6.2.2 Test sample . 6
6.2.3 Apparatus . 6
6.2.4 Procedure . 6
6.2.5 Expression of results . 6
6.2.6 Report . 6
6.3 Large particles in the dental amalgam alloy powder . 6
6.3.1 Principle . 6
6.3.2 Test sample . 7
6.3.3 Apparatus . 7
6.3.4 Test procedure . 7
6.3.5 Expression of the results . 7
6.3.6 Report . 7
6.4 Loss of mass from the capsule during mixing . 8
6.4.1 Principle . 8
6.4.2 Test sample . 8
6.4.3 Apparatus . 8
6.4.4 Test procedure . 8
6.4.5 Expression of the results . 9
6.4.6 Report . 9
6.5 Yield of amalgam from the capsule . 9
6.5.1 Principle .
...