SIST EN ISO 24234:2015
(Main)Dentistry - Dental amalgam (ISO 24234:2015)
Dentistry - Dental amalgam (ISO 24234:2015)
This International Standard 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).
With respect to dental mercury, the scope is limited solely to dental mercury which is supplied precapsulated
or in pre-dosed sachets. Both are limited to a mass sufficient for one mix. The mass of dental
mercury in one capsule or sachet shall be sufficient to produce a homogeneous plastic mix, appropriate
for a small or medium sized restoration in a single tooth. This International Standard is not applicable to
mercury supplied in masses greater than this in a single primary container (i.e. dental mercury in bulk).
Dental mercury supplied in bulk volumes will not conform to this International Standard.
This International Standard does not exclude the supply of dental amalgam alloy or dental mercury
separately.
This International Standard is not applicable to 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.
NOTE Dental mercury is at least 99,99 % pure, and as such, it is a metallic element of high commercial purity,
and not an alloy
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
SIST EN ISO 24234:2015
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
SIST EN ISO 24234:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 24234:2015
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SIST EN ISO 24234:2015
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.
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SIST EN ISO 24234:2015
EN ISO 24234:2015 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 24234:2015
EN ISO 24234:2015 (E)
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.
3
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SIST EN ISO 24234:2015
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SIST EN ISO 24234:2015
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
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SIST EN ISO 24234:2015
ISO 24234:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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Tel. + 41 22 749 01 11
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E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved
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SIST EN ISO 24234:2015
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 2015 – All rights reserved iii
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SIST EN ISO 24234:2015
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
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SIST EN ISO 24234:2015
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 Standard but it is recommended that, for the
assessment of possible biological hazards, reference should be made to ISO 10993 and ISO 7405.
To enhance the safety of dentists and support staff, and minimize the consequence that might result
from the accidental damage to containers during shipping, the scope is limited solely to dental mercury
that is supplied pre-capsulated or in pre-dosed sachets. Both are limited to a mass sufficient for one mix.
Safety precautions relating to marking, labelling, and packaging have been strengthened in this revision.
Restricting the scope to dental amalgam alloys with copper contents above 12 % by mass (i.e. “high
copper” dental amalgam alloy) was considered, because it is reported that restorations made with such
alloys, as a group, have a better long term survival rate than those made with traditional alloys (i.e.
“low copper” dental amalgam alloy). This was rejected since there are a few products with a low copper
content that produce restorations that are as durable as those produced using some of the high copper
products. (Factors other than the percentage of copper are important.) Also, it was felt that excluding
products from compliance should not be done by a change to the composition requirement; it should be
on the basis of a revision to the requirements for the properties that determine performance.
Inclusion of a requirement for corrosion resistance was considered. However, it was agreed that the data
available were insufficient to set a corrosion requirement in this edition of this International Standard.
A requirement for the corrosion resistance will be set and incorporated at the earliest possible date. It
is recommended that, in assessing corrosion resistance of a dental amalgam product (relative to other
dental amalgam products) reference should be made to ISO/TS 17988.
In the first edition of this International Standard (and before that in ISO 1559) a compression strength
test was used to determine the resistance to fracture of dental amalgam. Such a test, with a compressive
strength requirement, continues to be used in this edition. However, the Working Group recognizes
that dental amalgam, is in effect, a brittle material and it is evaluating a suitable test procedure that
produces tensile forces to initiate fracture in a way that replicates the clinical process. At this time,
the work has not reached the point at which this test (with a requirement) can be included in this
revision of the International Standard. When evaluation is completed, consideration will be given to
adding a requirement for fracture resistance that utilizes this test. This will be in the form of a Technical
Amendment.
Requirements and test methods for the capsules used for pre-capsulated products are contained in
ISO 13897.
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SIST EN ISO 24234:2015
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SIST EN ISO 24234:2015
INTERNATIONAL STANDARD ISO 24234:2015(E)
Dentistry — Dental amalgam
1 Scope
This International Standard 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).
With respect to dental mercury, the scope is limited solely to dental mercury which is supplied pre-
capsulated or in pre-dosed sachets. Both are limited to a mass sufficient for one mix. The mass of dental
mercury in one capsule or sachet shall be sufficient to produce a homogeneous plastic mix, appropriate
for a small or medium sized restoration in a single tooth. This International Standard is not applicable to
mercury supplied in masses greater than this in a single primary container (i.e. dental mercury in bulk).
Dental mercury supplied in bulk volumes will not conform to this International Standard.
This International Standard does not exclude the supply of dental amalgam alloy or dental mercury
separately.
This International Standard is not applicable to 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.
NOTE Dental mercury is at least 99,99 % pure, and as such, it is a metallic element of high commercial purity,
and not an alloy
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 286-2, Geometrical product specifications (GPS) — ISO code system for tolerances on linear sizes —
Part 2: Tables of standard tolerance classes and limit deviations for holes and shafts
ISO 1942, Dentistry — Vocabulary
ISO 3310-1, Test sieves — Technical requirements and testing — Part 1: Test sieves of metal wire cloth
ISO 3864-2, Graphical symbols — Safety colours and safety signs — Part 2: Design principles for product
safety labels
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 7488, Dental amalgamators
ISO 13565-2, Geometrical Product Specifications (GPS) — Surface texture: Profile method; Surfaces having
stratified functional properties — Part 2: Height characterization using the linear material ratio curve
ISO 13897, Dentistry — Amalgam capsules
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
© ISO 2015 – All rights reserved 1
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SIST EN ISO 24234:2015
ISO 24234:2015(E)
Globally Harmonized System of Classification and Labelling of Chemicals (GHS). United Nations, New York
and Geneva, 5th Edition, 2010, ISBN 92-1-116840-6
UN Recommendations on the Transport of Dangerous Goods, Model Regulations. United Nations, New York
and Geneva, 18th Edition 2013. ISBN 978-9211931466
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
dental amalgam alloy
alloy in fine particles, composed mainly of silver, tin, and copper, which, when mixed with dental
mercury, produces a dental amalgam
3.2
dental mercury
mercury supplied for use in the preparation of dental amalgam
Note 1 to entry: Dental mercury complying with the scope of this International Standard is supplied either pre-
capsulated (3.3) or in a pre-dosed sachet (3.5), with a mass that is considered suitable for a single small or medium
size restoration in a single tooth.
3.3
pre-capsulated product
product supplied in a sealed capsule that contains measured amounts of dental amalgam alloy powder
and dental mercury with masses that are appropriate for the production of a mass of dental amalgam
that is considered to be suitable for a single small or medium sized restoration in a single tooth
Note 1 to entry: The dental amalgam alloy powder and dental mercury are separated by a barrier that is broken
immediately prior to mixing to allow their contact. The capsule remains sealed until mixing has been completed.
3.4
dental amalgam alloy tablet
dental amalgam alloy powder that has been compressed to form a single entity for the purpose of
providing a pre-dosed quantity of the alloy that when mixed with an appropriate mass of dental mercury,
produces a mass of dental amalgam that is considered to be suitable for a single small or medium sized
restoration in a single tooth
Note 1 to entry: During mixing, the tablet is intended to break apart, forming a fine powder.
3.5
dental mercury sachet
measured quantity of dental mercury supplied in a sachet (for use in a reusable mixing capsule) in a
mass that, when mixed with an appropriate mass of dental amalgam alloy, produces a mass of dental
amalgam that is considered to be suitable for a single small or medium sized restoration in a single tooth
Note 1 to entry: The sachet is intended to rupture during mixing to allow the dental mercury to come into contact
with the dental amalgam alloy.
4 Requirements
4.1 Chemical composition and purity of the dental amalgam alloy
The manufacturer shall declare every element that is present in a concentration greater than, or equal
to 0,1 % (mass fraction). All alloying elements present in concentrations greater than 0,5 % (mass
fraction) shall be given by name with mass fraction values rounded to the nearest whole percentage
point. Alloying elements that are present in concentrations between 0,1 % and 0,5 % (mass fraction)
shall be named without a percentage value.
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SIST EN ISO 24234:2015
ISO 24234:2015(E)
Test in accordance with 6.1.
The chemical composition shall comply with Table 1.
The total for other elements present in concentrations greater than 0,01 % (mass fraction) but below 0,1 %
(mass fraction) that are not declared as alloying elements, shall not exceed 0,1 % (mass fraction).
Table 1 — Requirements for chemical composition of the dental amalgam alloy
Mass fraction
Element
%
silver ≥40
tin ≤32
copper ≤30
indium ≤5
palladium ≤1
platinum ≤I
zinc ≤2
mercury ≤3
4.2 Foreign material and large particles in the dental amalgam alloy powder
This requirement applies to all products with the exception of products in which dental mercury sachets
alone are supplied.
When tested in accordance with 6.2, no more than five particles of foreign material shall be found on
the sieve.
The mass of alloy particles that remain on the sieve shall not exceed 0,1 % (mass fraction) of the sample
used for this test.
4.3 Accuracy and variability of pre-proportioned masses
4.3.1 For dental mercury sachet products
The arithmetic mean of the mass of the dental mercury in the sachet shall be within ±2,0 % of the
manufacturer’s stated mass, when tested in accordance with 6.3.1.
The coefficient of variation of the mass of the dental mercury in the sachets shall not exceed 1,5 %, when
tested in accordance with 6.3.1.
4.3.2 For pre-capsulated products
The arithmetic means of the masses of both dental amalgam alloy and dental mercury in the capsule
shall be within ±2,0 % of the manufacturer’s stated masses, when tested in accordance with 6.3.2.
The coefficients of variation of the masses of the dental amalgam alloy and the dental mercury in the
capsules shall not exceed 1,5 %, when tested in accordance with 6.3.2.
4.3.3 For dental amalgam alloy tablet products
The arithmetic mean of the mass of the dental amalgam alloy tablet shall be within ±2,0 % of the
manufacturer’s stated mass, when tested in accordance with 6.3.3.
The coefficient of variation of the mass of the dental amalgam alloy tablets shall not exceed 1,5 %, when
tested in accordance with 6.3.3.
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SIST EN ISO 24234:2015
ISO 24234:2015(E)
4.4 Properties of the dental amalgam
This requirement applies to all products in which dental amalgam alloy is supplied.
Table 2 — Properties of the dental amalgam
Maximum Permitted dimensional Minimum compressive Minimum compressive
creep change during hardening strength at 1 h strength at 24 h
% % MPa MPa
2,0 −0,10 to +0,15 100 350
4.4.1 Creep
When tested in accordance with 6.5, either three out of three, or four out of five test-pieces shall meet
the requirement in Table 2.
4.4.2 Dimensional changes during hardening
When tested in accordance with 6.6, at least four out of five test-pieces shall meet the requirement in
Table 2.
4.4.3 Compressive strength at 1 h
When tested in accordance with 6.7, at least four out of five test-pieces, or eight out of ten test-pieces
shall meet the requirement in Table 2.
4.4.4 Compressive strength at 24 h
When tested in accordance with 6.7, at least four out of five test-pieces, or eight out of ten test-pieces
shall meet the requirement in Table 2.
4.5 Appearance of the mixed dental amalgam before setting
This requirement applies to all products in which dental amalgam alloy is supplied.
When the dental amalgam alloy and dental mercury are mixed according to the manufacturer’s
instructions and tested in accordance with 6.8, the dental amalgam shall form a coherent plastic mass
with a shiny surface before packing and remain a coherent plastic mass after packing.
5 Sampling
Procure containers of capsules (pre-capsulated products), or dental mercury sachets, or dental amalgam
alloy powder, or dental amalgam alloy tablets of the same lot in packages that have been produced for
retail.
For products supplied as free-flowing dental amalgam alloy powder or dental amalgam alloy tablets, at
least 50 g of dental amalgam alloy is required.
For pre-capsulated products, the number of capsules required depends on the masses of dental amalgam
alloy and dental mercury in each.
For dental mercury supplied in sachets, 25 sachets are required.
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SIST EN ISO 24234:2015
ISO 24234:2015(E)
6 Test methods
6.1 Chemical composition and purity of the dental amalgam alloy
Use a recognized, instrumented analytical procedure that has adequate sensitivity to determine the
composition of the dental amalgam alloy for the elements declared by the manufacturer in compliance
with 4.1.
For other elements that are detected at mass fractions greater than 0,01 %, but are not alloying elements
(declared as such by the manufacturer in compliance with 4.1), sum their mass fractions and report the
sum as the mass fraction of other elements.
NOTE Inductively-coupled plasma (ICP) spectroscopy is an example of a suitable analytical procedure.
6.2 Foreign material and large particles in the dental amalgam alloy powder
For dental amalgam alloy supplied as a free-flowing powder in bulk, weigh a (10,0 ± 0,1) g sample to an
accuracy of ±1 mg and record (m ).
s
For dental amalgam alloy supplied as tablets, place a tablet in a reusable capsule that complies with
ISO 13897. Break the tablet in the capsule to its constituent powder particles by using an amalgamator
(that complies with ISO 7488) at the machine setting and at one-half the time recommended by the dental
amalgam alloy manufacturer for mixing the dental amalgam alloy and dental mercury in accordance
with 7.3.1. If the manufacturer’s recommendations include any other action to break-up the tablet (e.g.
use of a pestle), incorporate this at the appr
...
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