EN ISO 20749:2018

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
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the requester.
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
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 . 9
6.5.2 Test sample . 9
ISO 20749:2017(E)
6.5.3 Apparatus . 9
6.5.4 Test procedure .10
6.5.5 Expression of the results .10
6.5.6 Report .10
6.6 Consistency of the dental amalgam from capsule to capsule .10
6.6.1 Principle .10
6.6.2 Test sample .11
6.6.3 Apparatus .11
6.6.4 Test-piece production .12
6.6.5 Microhardness measurement .13
6.6.6 Expression of the results .13
6.6.7 Report .14
6.7 Properties of the dental amalgam .14
6.7.1 Principle .14
6.7.2 Sample.14
6.7.3 Mould for the preparation of cylindrical test-pieces for determining creep,
dimensional change during hardening and compressive strength .14
6.7.4 Preparation of cylindrical test-pieces to determine compliance with
the requirements for creep, dimensional change during hardening and
compressive strength . .18
6.7.5 Determination of creep .20
6.7.6 Determination of dimensional change during hardening .21
6.7.7 Determination of compressive strength .22
6.8 Appearance of the mixed dental amalgam before setting .23
6.8.1 Principle .23
6.8.2 Apparatus .24
6.8.3 Test procedure .24
6.8.4 Expression of the results .24
6.8.5 Report .25
6.9 Length tolerance for the capsule .25
6.9.1 Principle .25
6.9.2 Test sample .25
6.9.3 Apparatus .25
6.9.4 Test procedure .25
6.9.5 Expression of the results .25
6.9.6 Report .25
7 Marking, labelling and packaging .26
7.1 Packaging .26
7.2 Marking and labelling .26
7.2.1 Information.26
7.2.2 Labelling of a package for dental mercury .26
7.2.3 Labelling of the outer surface of package or container used for shipping .27
7.3 Manufacturer’s instructions .27
7.3.1 General instructions.27
7.3.2 Precautionary notes .27
Bibliography .28
iv © ISO 2017 – All rights reserved

ISO 20749:2017(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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative
materials.
ISO 20749:2017(E)
Introduction
This is the first edition of this document. Its scope is limited solely to dental amalgam alloy and dental
mercury that are supplied pre-capsulated in masses that are sufficient to produce a mass of dental
amalgam that is considered to be suitable for a single small or medium size restoration in a single tooth.
Dental amalgam alloy and dental mercury are the essential and only components of dental amalgam
restorative material. This document 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, those for the capsules themselves and the requirements for packaging and marking.
This document has been developed in response to the UNEP Minamata Convention on Mercury. The
objective of the Minamata Convention is to reduce anthropogenic mercury pollution by restricting
the use of mercury, products containing mercury and materials that release mercury during use. In
this convention, dental amalgam is classified as a “mercury-added product”, for which parties to the
agreement are to adopt two or more measures from a list of nine. One of these is “restricting the
use of dental amalgam to its encapsulated form”. In some countries, the term encapsulated has been
interpreted as the pre-capsulated form alone. Given the increased vigilance on the use of dental amalgam
products since 2013, when the Minamata Agreement was signed, this document will enable countries
that do not allow the use of products other than those that are pre-capsulated to adopt an ISO standard
on dental amalgam. Not all of the membership of the UN has signed the Minamata Convention and in
non-signatory countries, dental amalgam products outside the scope of this document, but within the
scope of ISO 24234, will continue to be marketed. Thus, both standards are required to provide full
global coverage for compliance.
Although this document is based on ISO 24234, there have been significant technical changes. Also, the
requirements for the capsule that were in ISO 13897 have been transferred to this document, treating
a product that falls within the scope as an entity. This document differs technically from ISO 24234 in
the following respects:
— The scope of this document is restricted to pre-capsulated products alone.
— A requirement for packaging and capsule to be free from contamination is present.
— The requirement concerning foreign matter in the dental amalgam alloy powder has been removed.
— A requirement for loss of mass from the capsule during mixing has been added.
— A requirement for the yield of dental amalgam from a capsule replaces the requirement for the
masses of dental mercury and dental amalgam powder present before mixing.
— A requirement for the consistency in the ratio of dental mercury to dental amalgam alloy powder
in capsules has been changed radically. Determination of the effect of variation in this ratio upon
properties replaces weighing the dental mercury and the dental amalgam alloy powder.
— Requirements for the capsule have been introduced and revised technically.
A decision was taken not to alter requirements upon which capsulation has no bearing, these being:
— the requirements on chemical composition and purity of the dental amalgam alloy;
— the requirements for the properties of dental amalgam;
— the requirement for the appearance of dental amalgam before setting.
As with ISO 24234, the inclusion of a requirement for corrosion resistance was considered. However, it
was agreed that the data available were insufficient to set a corrosion resistance requirement in this
edition of this document. 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 can be made to ISO/TS 17988.
vi © ISO 2017 – All rights reserved

INTERNATIONAL STANDARD ISO 20749:2017(E)
Dentistry — Pre-capsulated dental amalgam
1 Scope
This document 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.
This document 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.
This document 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. 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 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 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
Globally Harmonized System of Classification and Labelling of Chemicals (GHS). United Nations, New York
and Geneva, 5th Revised Edition, 2013, ISBN 978-92-1-117067-2
ISO 20749:2017(E)
UN Recommendations on the Transport of Dangerous Goods, Model Regulations. United Nations, New York
and Geneva, 18th Edition, 2013, ISBN 978-92-1-193146-6
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
dental amalgam alloy
alloy in fine particles, composed mainly of silver, tin and copper, which, when mixed with dental mercury
(3.2), produces a dental amalgam
3.2
dental mercury
mercury supplied for use in the preparation of dental amalgam
3.3
pre-capsulated product
product supplied in a sealed capsule that contains measured amounts of dental amalgam alloy (3.1)
powder and dental mercury (3.2) 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 size restoration in a single tooth
Note 1 to entry: The dental amalgam alloy powder and dental mercury (3.2) 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
self-activating capsule
pre-capsulated product (3.3) capsule in which contact between the dental amalgam alloy (3.1) powder
and the dental mercury (3.2) occurs automatically during mixing
Note 1 to entry: There is another type of design that requires a physical action by the user to rupture the
separating barrier for activation (3.6) before placing the capsule in the mechanical mixing machine.
3.5
percentage by mass
mass fraction expressed as a percentage
Note 1 to entry: The terminology “mass fraction” is favoured when expressing a composition in which this is
measured by mass. However, for dental amalgam alloys (3.1), the terminology “by mass” is in general use. Because
it is the intention for this document to be user-friendly, the latter has been adopted. In both cases, the composition
is expressed as a percentage.
3.6
activation
action that renders the capsulated dental amalgam alloy (3.1) powder and dental mercury (3.2) mixable
3.7
dental amalgam pellet
coherent mass of dental amalgam that is produced by mixing and drops from the opened and
upended capsule
Note 1 to entry: A light tap of the rim of the open capsule on a hard surface may be required to dislodge the pellet
and is permitted.
2 © ISO 2017 – All rights reserved

ISO 20749:2017(E)
4 Requirements
4.1 Package and capsule contamination
The interior of the packaging container and the outer surface of the capsules shall be free of both dental
mercury and dental amalgam alloy powder contamination when tested in accordance with 6.1.
4.2 Chemical composition and purity of the dental amalgam alloy
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 ≤1
Zinc ≤2
Mercury ≤3
The manufacturer shall declare every element that is present intentionally and in a concentration
greater than or equal to 0,1 % (by mass). All alloying elements present in concentrations greater than
0,5 % (by mass) shall be given by name with percentage by mass values rounded to the nearest whole
percentage point. Alloying elements that are present in concentrations between 0,1 % and 0,5 % (by
mass) shall be named without a percentage value.
Determine the chemical composition in accordance with 6.2.
The chemical composition shall comply with Table 1.
The total for elements that are not declared by the manufacturer as alloying elements shall not exceed
0,1 % (by mass).
4.3 Large particles in the dental amalgam alloy powder
When compliance with this requirement is determined in accordance with 6.3, the proportion of the
dental amalgam alloy powder that occurs as particles that have a size greater than 150 μm shall not
exceed 0,1 % (by mass).
4.4 Loss of mass from the capsule during mixing
When compliance with this requirement is determined in accordance with 6.4, the average loss in mass
of dental mercury and dental amalgam alloy powder from 15 capsules (during mixing in accordance
with the manufacturer’s instructions) shall not exceed 0,5 mg.
Also, the loss from any one capsule shall not exceed 1 mg.
4.5 The yield of amalgam from the capsule
When compliance with this requirement is determined in accordance with 6.5, the average mass of the
pellet of dental amalgam obtained from a capsule (for a sample of 15 capsules) shall not be less than
95,0 % of the sum of the manufacturer’s stated masses for dental mercury and dental amalgam alloy in
the capsule.
ISO 20749:2017(E)
Also, no capsule shall yield a pellet of dental amalgam that is less than 90,0 % of the sum of the
manufacturer’s stated masses for dental mercury and dental amalgam alloy in the capsule.
There may be some small free pieces of dental amalgam as well as the pellet. These are available for use
and are regarded as part of the yield, i.e. their mass should be added to that of the pellet.
4.6 Consistency of the dental amalgam from capsule to capsule
When compliance with this requirement is determined in accordance with 6.6, the mean value of the
hardness for dental amalgam produced from the content of any one capsule shall not be less than 85 %
of the overall mean value of the hardness of the dental amalgam obtained for a specified number of
capsules.
NOTE The mean value for the hardness of a test-piece is calculated from all measurements made on that
test-piece. The overall mean value for hardness is calculated from all measurements on all test-pieces.
4.7 Properties of the dental amalgam
Table 2 — Properties of the dental amalgam
Minimum compressive
Maximum Permitted dimensional Minimum compressive
strength at 24 h
creep change during hardening strength at 1 h
% % MPa
MPa
2,0 −0,10 to +0,15 100 350
4.7.1 Creep
When compliance with this requirement is determined in accordance with 6.7, the results for either
three out of three or four out of five test-pieces shall meet the requirement in Table 2.
4.7.2 Dimensional changes during hardening
When compliance with this requirement is determined in accordance with 6.7, the results for at least
four out of five test-pieces shall meet the requirement in Table 2.
4.7.3 Compressive strength at 1 h
When compliance with this requirement is determined in accordance with 6.7, the results for at least
four out of five test-pieces or eight out of 10 test-pieces shall meet the requirement in Table 2.
4.7.4 Compressive strength at 24 h
When compliance with this requirement is determined in accordance with 6.7, the results for at least
four out of five test-pieces or eight out of 10 test-pieces shall meet the requirement in Table 2.
4.8 Appearance of the mixed dental amalgam before setting
When compliance with this requirement is determined in accordance with 6.8, when the dental
amalgam alloy and dental mercury are mixed according to the manufacturer’s instructions, the dental
amalgam shall form a coherent plastic mass with a shiny surface before packing and remain a coherent
plastic mass after packing.
4.9 Length tolerance for the capsule
When compliance with this requirement is determined in accordance with 6.9, the overall length of the
activated capsule shall be within ±1 mm of the length specified by the manufacturer. All 10 capsules in
the sample tested shall meet the requirement.
4 © ISO 2017 – All rights reserved

ISO 20749:2017(E)
5 Sampling
Procure containers of capsules of the same lot in packages that have been produced for retail.
NOTE The number of capsules required depends on the masses of dental amalgam alloy and dental mercury
in each.
6 Test methods
6.1 Package and capsule contamination
6.1.1 Principle
Any loss of either component from a capsule during transit is a concern. Such a loss can be detected by
visual examination using low power magnification.
6.1.2 Test sample
Test all containers holding the capsules from the sample procured for testing, as well as 25 capsules
selected at random from the same sample.
6.1.3 Apparatus
Stereomicroscope, ×10 magnification.
6.1.4 Procedure
Using the stereomicroscope, inspect the interior surfaces of all the containers holding capsules and the
external surfaces of the 25 capsules. Examine these for traces of dental amalgam alloy powder and
visible beads of dental mercury.
6.1.5 Expression of the results
Record the observations.
6.1.6 Report
6.1.6.1 General
If contamination is seen on the surface of a container, report this and the number of containers that is
contaminated.
If it is the capsule surface that is contaminated, report this and the number of capsules that is
contaminated.
6.1.6.2 Compliance
Report whether the product does or does not comply with the requirement for package and capsule
contamination, in accordance with 4.1.
6.2 Chemical composition and purity of the dental amalgam alloy
6.2.1 Principle
Chemical analysis of the dental amalgam alloy using an instrumented technique for metallic materials.
ISO 20749:2017(E)
6.2.2 Test sample
Extract dental amalgam alloy powder from a capsule selected at random. This sample should not be
contaminated with the dental mercury during extraction from the capsule.
6.2.3 Apparatus
Recognized, instrumented analytical procedure, with a sensitivity adequate to determine the
composition of the dental amalgam alloy for the elements declared by the manufacturer in compliance
with 4.2.
NOTE Inductively-coupled plasma (ICP) spectroscopy is an example of a suitable analytical procedure.
6.2.4 Procedure
Determine the composition of the dental amalgam alloy for the elements declared by the manufacturer
in compliance with 4.2.
6.2.5 Expression of results
Record all elements detected in concentrations greater than 0,01 % (by mass) and their proportions as
percentages by mass.
For other elements that are detected in concentrations greater than 0,01 % (by mass) and below 0,1 %
(by mass), but are not alloying elements (declared as such by the manufacturer in compliance with 4.2),
sum these values and record the sum as the percentage (by mass) of other elements.
6.2.6 Report
6.2.6.1 General
Report the analytical method used. Report any irregularities in the test procedure used.
Report the percentages (by mass) for those elements that are alloying elements according to Table 1
and reported as such by the manufacturer. If any other element is declared by the manufacturer as an
alloying element, report this and its percentage (by mass).
Report the sum of the percentages (by mass) of undeclared elements present in concentrations greater
than 0,01 % (by mass).
Report each undeclared element that was found in a concentration greater than 0,1 % (by mass) by
name and the percentage (by mass).
6.2.6.2 Compliance
Report whether the product does or does not comply with the requirement for composition and purity
in accordance with 4.2
6.3 Large particles in the dental amalgam alloy powder
6.3.1 Principle
The large particles (defined as >150 μm in size) separated from the sample (a known mass of dental
amalgam powder) are weighted.
6 © ISO 2017 – All rights reserved

ISO 20749:2017(E)
6.3.2 Test sample
Select and open a sufficient number of capsules to obtain a (10,0 ± 0,1) g sample of dental amalgam alloy
powder. This sample should not be contaminated with the dental merc
...