EN ISO 24234:2015
(Main)Dentistry - Dental amalgam (ISO 24234:2015)
Dentistry - Dental amalgam (ISO 24234:2015)
ISO 24234:2015 specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking (including those for dental mercury).
It is applicable to dental amalgam alloys supplied in the form of a free-flowing powder in bulk, or a powder compressed to form a tablet, or a powder in a capsule (i.e. pre-capsulated).
Zahnheilkunde - Dentale Amalgame (ISO 24234:2015)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für dentale Amalgamlegierungen und für dentales Quecksilber, das zur Herstellung von dentalem Amalgam geeignet ist, fest. Ebenso sind Anforderungen an und Prüfverfahren für dieses dentale Amalgam sowie Anforderungen an die Verpackung und Kennzeichnung (einschließlich derjenigen für dentales Quecksilber) enthalten.
Sie gilt für dentale Amalgamlegierungen, die als frei fließendes loses Pulver, als in Tablettenform gepresstes Pulver, oder als Pulver in einer Kapsel (d. h. in vordosierter Kapsel) geliefert werden.
Der Anwendungsbereich wird für dentales Quecksilber ausschließlich auf das in vordosierten Kapseln oder in vordosierten Beuteln gelieferte beschränkt. Beide Lieferformen sind auf eine für eine Mischung ausreichende Masse begrenzt. Die Masse an dentalem Quecksilber in einer Kapsel oder in einem Beutel muss für die Herstellung eines plastischen homogenen Gemischs genügen, das für eine einzelne kleine oder mittelgroße Restauration in einem einzelnen Zahn ausreichend ist. Diese Internationale Norm gilt nicht für die Bereitstellung von Quecksilber in größeren als der in einem einzelnen Primärbehälter (d. h. dentales Quecksilber in loser Form) enthaltenen Massen. In loser Form geliefertes dentales Quecksilber entspricht nicht dieser Internationalen Norm.
Diese Internationale Norm schließt die getrennte Bereitstellung von dentalen Amalgamlegierungen oder dentalem Quecksilber nicht aus.
Diese Internationale Norm gilt weder für Legierungen, die für die Verwendung mit flüssigen Metallen vorgesehen sind, die kein dentales Quecksilber sind, noch für flüssige Metalllegierungen.
Médecine bucco-dentaire - Amalgame dentaire (ISO 24234:2015)
L'ISO 24234:2015 spécifie les exigences et les méthodes d'essai applicables aux alliages pour amalgame dentaire utilisés dans la préparation des amalgames dentaires, les exigences et les méthodes d'essai de ces amalgames dentaires et les exigences d'emballage et de marquage correspondantes (y compris celles du mercure à usage dentaire).
Elle est applicable aux alliages pour amalgame dentaire livrés sous forme de poudre en vrac, de poudre compressée en tablettes ou de poudre en capsules (c'est à dire des capsules prédosées).
Zobozdravstvo - Zobni amalgam (ISO 24234:2015)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2015
1DGRPHãþD
SIST EN ISO 24234:2005
SIST EN ISO 24234:2005/A1:2011
Zobozdravstvo - Zobni amalgam (ISO 24234:2015)
Dentistry - Dental amalgam (ISO 24234:2015)
Zahnheilkunde - Dentale Amalgame (ISO 24234:2015)
Médecine bucco-dentaire - Amalgame dentaire (ISO 24234:2015)
Ta slovenski standard je istoveten z: EN ISO 24234:2015
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 24234
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.060.10 Supersedes EN ISO 24234:2004
English Version
Dentistry - Dental amalgam (ISO 24234:2015)
Médecine bucco-dentaire - Amalgame dentaire (ISO Zahnheilkunde - Dentale Amalgame (ISO 24234:2015)
24234:2015)
This European Standard was approved by CEN on 3 January 2015.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 24234:2015 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 24234:2015) 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 November 2015, and conflicting national standards shall be withdrawn
at the latest by November 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 24234:2004.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 24234:2015 has been approved by CEN as EN ISO 24234:2015 without any modification.
INTERNATIONAL ISO
STANDARD 24234
Second edition
2015-05-01
Dentistry — Dental amalgam
Médecine bucco-dentaire — Amalgame dentaire
Reference number
ISO 24234:2015(E)
©
ISO 2015
ISO 24234:2015(E)
© ISO 2015
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.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved
ISO 24234:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 2
4.1 Chemical composition and purity of the dental amalgam alloy . 2
4.2 Foreign material and large particles in the dental amalgam alloy powder . 3
4.3 Accuracy and variability of pre-proportioned masses . 3
4.4 Properties of the dental amalgam . 4
4.5 Appearance of the mixed dental amalgam before setting . 4
5 Sampling . 4
6 Test methods . 5
6.1 Chemical composition and purity of the dental amalgam alloy . 5
6.2 Foreign material and large particles in the dental amalgam alloy powder . 5
6.3 Determination of the accuracy and variability of pre-proportioned masses . 5
6.4 Preparation of test-pieces to determine compliance with the requirements for creep,
dimensional change during hardening, and compressive strength . 7
6.5 Determination of creep .12
6.6 Determination of dimensional change during hardening.12
6.7 Determination of compressive strength .13
6.8 Appearance of the mixed dental amalgam before setting .14
7 Marking, labelling, and packaging .15
7.1 Packaging .15
7.2 Marking .15
7.3 Manufacturer’s instructions .17
Bibliography .19
ISO 24234:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
Restorative Materials.
This second edition cancels and replaces the first edition (ISO 24234:2004), which has been technically
revised. It also incorporates the amendment ISO 24234:2004/Amd, 1. The following changes have been
made.
— The title of this International Standard has been changed to reflect the content and requirements
more accurately.
— The supply of dental mercury in units of greater mass (bulk dental mercury) is no longer within
the scope of this International Standard. Through this restriction on the supply of dental mercury
for a product to comply with this International Standard (introduced by ISO/TC 106 SC1), a
general concern about the environmental impact from the sale of mercury in bulk volumes (for all
applications) is addressed.
— As a consequence of the removal of dental mercury supplied in bulk quantities from the scope of this
International Standard, requirements for freedom from contamination (by water, oil and foreign
bodies) and free pouring of dental mercury are no longer present in this International Standard.
— The values for the requirements on the dimensional change during hardening and the compressive
strength at 1 h and 24 h have been revised. “Permitted dimensional change during hardening” is
changed from (- 0,10 to +0,20) % to (−0,10 to +0,15) %. Furthermore, the “Minimum compressive
strength at 1h” is increased from 80 to 100 MPa, and the “Minimum compressive strength at 24 h”
is increased from 300 to 350 MPa.
— Provisions for packaging and marking have been revised.
— Markings required for mercury safety warnings and precautions have been revised.
— Normative annexes on procedures for corrosion testing have been removed from this International
Standard and are now contained in a new International Technical Specification, ISO/TS 17988:
Dentistry — Corrosion test methods for dental amalgam.
iv © ISO 2015 – All rights reserved
ISO 24234:2015(E)
Introduction
Dental amalgam alloy and dental mercury are the essential and only components of dental amalgam
restorative material. This International Standard specifies the requirements and the test methods for
dental amalgam alloy that is suitable for the preparation of dental amalgam, together with those for
the set dental amalgam and the requirements for packaging and marking (including those for dental
mercury), of which this International Standard is the second edition.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazard are not included in this International S
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.