EN ISO 24234:2004
(Main)Dentistry - Mercury and alloys for dental amalgam (ISO 24234:2004)
Dentistry - Mercury and alloys for dental amalgam (ISO 24234:2004)
ISO 24234:2004 specifies the requirements and test methods for alloys and for mercury suitable for the preparation of dental amalgam, together with the requirements and test methods for that amalgam and the requirements for packaging and marking.
It is applicable to alloys supplied in the form of either a powder in bulk, or a powder compressed to form a tablet, or a powder in predosed capsules.
It is applicable to dental mercury supplied either in bulk quantities, or in predosed sachets, or in predosed capsules.
ISO 24234:2004 does not exclude the supply of alloy or mercury separately.
ISO 24234:2004 is not applicable to alloys intended for use with liquid metals that are not mercury, nor is it applicable to liquid metal alloys.
Zahnheilkunde - Quecksilber und Legierungen für zahnärztliche Amalgame (ISO 24234:2004)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für Legierungen und für Quecksilber, die zur Herstellung von zahnärztlichem Amalgam geeignet sind, zusammen mit den Anforderungen und Prüfverfahren für dieses Amalgam sowie die Anforderungen an die Verpackung und Kennzeichnung fest.
Sie gilt für Legierungen, die als loses Pulver, als Pulver, das in Tablettenform gepresst wurde, oder als Pulver in vordosierten Kapseln geliefert werden.
Sie gilt für dentales Quecksilber, das in losen Mengen oder in vordosierten Kapseln geliefert wird.
Diese Internationale Norm schließt Legierungen oder Quecksilber, die getrennt geliefert werden, nicht aus.
Diese Internationale Norm gilt nicht für Legierungen, die für die Verwendung mit flüssigen Metallen, die kein Quecksilber sind, vorgesehen sind, und gilt auch nicht für flüssige Metalllegierungen.
Art dentaire - Mercure et alliages pour amalgame dentaire (ISO 24234:2004)
L'ISO 24234:2004 spécifie les exigences et les méthodes d'essai applicables aux alliages et au mercure utilisés dans la préparation des amalgames dentaires, les exigences et les méthodes d'essai de l'amalgame lui-même et les exigences d'emballage et de marquage correspondantes.
Elle est applicable aux alliages livrés sous forme de poudre en vrac, de poudre compressée en tablettes ou de poudre en capsules prédosées.
Elle est applicable au mercure à usage dentaire livré en vrac, en sachets prédosés ou en capsules prédosées.
L'ISO 24234:2004 n'exclut pas la fourniture d'alliage ou de mercure séparément.
L'ISO 24234:2004 n'est pas applicable aux alliages destinés à l'usage avec des métaux liquides autres que le mercure ni aux alliages métalliques liquides.
Zobozdravstvo - Živo srebro in zlitine za zobni amalgam (ISO 24234:2004)
Ta mednarodni standard določa zahteve in preskusne metode za zlitine in živo srebro, primerne za pripravo zobnega amalgama, skupaj z zahtevami in preskusnimi metodami za ta amalgam ter zahtevami za pakiranje in označevanje. Velja za zlitine, ki se dobavljajo v obliki praška v razsutem stanju, praška, stisnjenega v tableto, ali praška v predodmerjenih kapsulah. Velja za živo srebro za zobozdravstvo, ki se dobavlja v razsutem stanju, v predodmerjenih vrečkah ali predodmerjenih kapsulah. Ta mednarodni standard ne izključuje ločene dobave zlitine in živega srebra. Ta mednarodni standard ne velja za zlitine, ki se uporabljajo s tekočimi kovinami, ki niso živo srebro, in ne velja za tekoče kovinske zlitine.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2005
1DGRPHãþD
SIST EN 21560:2000
Zobozdravstvo - Živo srebro in zlitine za zobni amalgam (ISO 24234:2004)
Dentistry - Mercury and alloys for dental amalgam (ISO 24234:2004)
Zahnheilkunde - Quecksilber und Legierungen für zahnärztliche Amalgame (ISO
24234:2004)
Art dentaire - Mercure et alliages pour amalgame dentaire (ISO 24234:2004)
Ta slovenski standard je istoveten z: EN ISO 24234:2004
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
October 2004
ICS 11.060.10 Supersedes EN 21560:1991
English version
Dentistry - Mercury and alloys for dental amalgam (ISO
24234:2004)
Art dentaire - Mercure et alliages pour amalgame dentaire Zahnheilkunde - Quecksilber und Legierungen für
(ISO 24234:2004) zahnärztliche Amalgame (ISO 24234:2004)
This European Standard was approved by CEN on 16 August 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 24234:2004: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 24234:2004) 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 April 2005, and conflicting national
standards shall be withdrawn at the latest by April 2005.
This document supersedes EN 21560:1991.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 24234:2004 has been approved by CEN as EN ISO 24234:2004 without any
modifications.
INTERNATIONAL ISO
STANDARD 24234
First edition
2004-10-15
Dentistry — Mercury and alloys for dental
amalgam
Art dentaire — Mercure et alliages pour amalgame dentaire
Reference number
ISO 24234:2004(E)
©
ISO 2004
ISO 24234:2004(E)
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ii © ISO 2004 – All rights reserved
ISO 24234:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Requirements . 3
4.1 General. 3
4.2 Chemical composition of the alloy. 3
4.3 Biocompatibility . 4
4.4 Foreign material and large particles in the alloy powder . 4
4.5 Contamination of the mercury by oil, water and foreign material . 4
4.6 Purity of mercury — Free pouring. 4
4.7 Variability of preproportioned masses . 4
4.8 Properties of the amalgam. 5
4.9 Appearance of the mixed amalgam before setting. 5
5 Sampling . 6
6 Test methods. 6
6.1 Chemical composition of the alloy. 6
6.2 Foreign material and large particles in the alloy powder . 6
6.3 Contamination of the mercury by oil, water or foreign material . 7
6.4 Free-pouring of mercury . 8
6.5 Determination of the variability of preproportioned masses . 8
6.6 Preparation of test specimens to determine compliance with the requirements for creep,
dimensional change and compressive strength . 9
6.7 Determination of creep. 14
6.8 Determination of dimensional change during hardening. 14
6.9 Determination of compressive strength.15
6.10 Appearance of the mixed amalgam before setting. 15
7 Marking, labelling and packaging . 16
7.1 Packaging . 16
7.2 Marking. 16
7.3 Manufacturer’s instructions. 17
Annex A (normative) Determination of immersion corrosion for dental amalgam . 19
Annex B (normative) Potentiostatic determination of corrosion for dental amalgam . 24
Bibliography . 28
Table 1 — Requirements for chemical composition of the alloy . 4
Table 2 — Properties of amalgam . 5
Table 3 — Schedule for the preparation of test specimens .13
Table B.1 — Potential settings for different reference electrodes and temperatures of
the reference electrodes. 27
ISO 24234:2004(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 24234 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
This International Standard cancels and replaces ISO 1559:1995, ISO 1559:1995/Cor.1:1997 and
ISO 1560:1985.
A number of technical revisions have been made as improvements or as a consequence of combining the
International Standards that have been replaced.
The scope of this International Standard applies to alloys for dental amalgam and dental mercury,
whether provided individually or together.
The clause permitting a deviation in the composition of alloys for amalgam has been removed.
Guidance on biocompatibility assessment has been introduced.
A limit on the presence of large alloy particles has been introduced.
The requirement for loss of mercury from predosed capsules has been removed, since it is a requirement
in ISO 13897.
The values for the requirements on creep, dimensional change and compressive strength at 1 h have
been revised.
The criterion for compliance with the compressive strength requirements has been revised.
Provisions for packaging and marking have been revised.
Markings required for mercury safety warnings and precautions have been revised to conform to
ISO requirements and the United Nations Globally Harmonized System of Classification and Labelling of
Chemicals (GHS). They are no longer dependent upon national or regional requirements.
Procedures for corrosion testing have been added as normative annexes.
iv © ISO 2004 – All rights reserved
ISO 24234:2004(E)
Introduction
Dental amalgam alloy and mercury are the essential and only components of dental amalgam restorative
material. This International Standard combines the requirements and the test methods for the alloy with those
for the mercury in a single standard, of which this is the first edition. Formerly, these were contained in two
separate standards.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard, but it is recommended that, in assessing possible
...
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