SIST EN ISO 20749:2023

Dentistry - Pre-capsulated dental amalgam (ISO 20749:2023)

This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy powder and dental mercury in quantities suitable for the creation of a single dental restoration.
This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking.
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.
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 described in ISO 24234.

Zahnheilkunde – Dentalamalgam in Kapseln (ISO 20749:2023)

Dieses Dokument legt die Anforderungen und Prüfverfahren für Dentalamalgamprodukte fest, das an den Anwender in Kapseln, vordosiert mit dentalem Amalgamlegierungspulver und dentalem Quecksilber in Mengen, die zur Herstellung einer einzelnen dentalen Restauration geeignet ist, ausgeliefert wird.
Dieses Dokument legt die Anforderungen und Prüfverfahren für die Kapsel sowie die Anforderungen an die Verpackung und Kennzeichnung fest.
Dieses Dokument ist nicht anwendbar für andere metallische Werkstoffe, bei denen ein Legierungspulver mit einer Legierung, die bei Umgebungstemperatur flüssig ist, reagiert, um einen festen metallischen Werkstoff herzustellen, der für dentale Restaurationen vorgesehen ist.
Dieses Dokument beschränkt sich auf Dentalamalgamprodukte, die ausschließlich in vorgekapselter Form vermarktet werden. Andere Produkte, die für die Herstellung von dentalen Amalgamrestaurationen bestimmt sind (dentale Amalgamlegierung als frei fließendes Pulver, das in großen Mengen geliefert wird, dentales Amalgamlegierungspulver, das in Form von gepressten Tabletten geliefert wird, und dentale Quecksilberbeutel), sind in ISO 24234 beschrieben.

Médecine bucco-dentaire - Amalgame dentaire en capsules prédosées (ISO 20749:2023)

Le présent document spécifie les exigences et les méthodes d’essai applicables aux amalgames dentaires fournis à l’utilisateur sous forme de capsules, prédosées avec la poudre d’alliage pour amalgame dentaire et le mercure à usage dentaire dans des quantités appropriées pour créer une seule restauration dentaire.
Le présent document spécifie les exigences et les méthodes d'essai applicables à la capsule, et les exigences d'emballage et de marquage.
Le présent document 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.
Le présent document est limité aux amalgames dentaires commercialisés sous forme de capsules prédosées uniquement. Les autres produits destinés à être utilisés lors de la production de matériaux de restauration des amalgames dentaires (alliages d’amalgame dentaire sous forme de poudre fluide en vrac, poudre d’alliage pour amalgame dentaire sous forme de tablettes comprimées et sachets de mercure à usage dentaire) sont décrits dans l’ISO 24234.

Zobozdravstvo - Pripravljeni zobni amalgam (ISO 20749:2023)

Zobna amalgamska zlitina in živo srebro sta bistveni in edini sestavini materiala za obnovo zob iz zobnega amalgama. Ta dokument 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.
Ta dokument določa zahteve in preskusne metode za pripravljeni zobni amalgam ter zahteve za embalažo in označevanje.

General Information

• Status: Published
• Public Enquiry End Date: 29-Apr-2022
• Publication Date: 12-Sep-2023
• ICS: 11.060.10 - Dental materials
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Aug-2023
• Due Date: 06-Oct-2023
• Completion Date: 13-Sep-2023
• Ref Project: EN ISO 20749:2023 - Dentistry - Pre-capsulated dental amalgam (ISO 20749:2023)

Relations

• Replaces: SIST EN ISO 20749:2018 - Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017)
• Effective Date: 01-Sep-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2023
Nadomešča:
SIST EN ISO 20749:2018
Zobozdravstvo - Pripravljeni zobni amalgam (ISO 20749:2023)
Dentistry - Pre-capsulated dental amalgam (ISO 20749:2023)
Zahnheilkunde – Dentalamalgam in Kapseln (ISO 20749:2023)
Médecine bucco-dentaire - Amalgame dentaire en capsules prédosées (ISO
20749:2023)
Ta slovenski standard je istoveten z: EN ISO 20749:2023
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20749
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 20749:2018
English Version
Dentistry - Pre-capsulated dental amalgam (ISO
20749:2023)
Médecine bucco-dentaire - Amalgame dentaire en Zahnheilkunde - Dentalamalgam in Kapseln (ISO
capsules prédosées (ISO 20749:2023) 20749:2023)
This European Standard was approved by CEN on 13 March 2023.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20749:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 20749:2023) 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 January 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
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.
This document supersedes EN ISO 20749:2018.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 20749:2023 has been approved by CEN as EN ISO 20749:2023 without any modification.

INTERNATIONAL ISO
STANDARD 20749
Second edition
2023-06
Dentistry — Pre-capsulated dental
amalgam
Médecine bucco-dentaire — Amalgame dentaire en capsules
prédosées
Reference number
ISO 20749:2023(E)
ISO 20749:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 20749:2023(E)
Contents Page
Foreword .v
Introduction .vii
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 Yield of dental 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 General . 4
4.7.2 Creep . 4
4.7.3 Dimensional changes during hardening . 4
4.7.4 Compressive fracture stress at 2 h . 4
4.7.5 Compressive fracture stress at 24 h . 4
4.8 Appearance of mixed dental amalgam before setting . 5
4.9 Corrosion resistance of the dental amalgam . 5
4.10 Length tolerance for the capsule . 5
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 Treatment of the results . 6
6.1.6 Report. 6
6.2 Chemical composition and purity of the dental amalgam alloy . 6
6.2.1 Principle . 6
6.2.2 Test sample . 6
6.2.3 Apparatus . 6
6.2.4 Procedure . 7
6.2.5 Treatment of the results . 7
6.2.6 Report. 7
6.3 Large particles in the dental amalgam alloy powder . 8
6.3.1 Principle . 8
6.3.2 Test sample . 8
6.3.3 Apparatus . 8
6.3.4 Procedure . 8
6.3.5 Treatment of the results . 8
6.3.6 Report. 8
6.4 Loss of mass from the capsule during mixing . 9
6.4.1 Principle . 9
6.4.2 Test sample . 9
6.4.3 Apparatus . 9
6.4.4 Test procedure. 9
6.4.5 Treatment of the results . 10
6.4.6 Report. 10
6.5 Yield of amalgam from the capsule . 11
iii
ISO 20749:2023(E)
6.5.1 Principle . 11
6.5.2 Test sample . 11
6.5.3 Apparatus . 11
6.5.4 Test procedure. 11
6.5.5 Treatment of the results .12
6.5.6 Report.12
6.6 Consistency of the dental amalgam from capsule to capsule .13
6.6.1 Principle . 13
6.6.2 Test sample . 13
6.6.3 Apparatus . 13
6.6.4 Test piece production . 14
6.6.5 Procedure . 14
6.6.6 Microhardness measurement . 15
6.6.7 Treatment of the results . 15
6.6.8 Report. 16
6.7 Properties of the dental amalgam . 16
6.7.1 Principle . 16
6.7.2 Mould for the preparation of test pieces for determining creep, dimensional
change during hardening and compressive fracture stress . 16
6.7.3 Test sample . 21
6.7.4 Test piece production . 21
6.7.5 Procedure for the determination of creep. 23
6.7.6 Procedure for the determination of dimensional change during hardening . 24
6.7.7 Procedure for the determination of compressive fracture stress .26
6.8 Appearance of the mixed dental amalgam before setting .28
6.8.1 Principle .28
6.8.2 Apparatus .28
6.8.3 Procedure .28
6.8.4 Treatment of the results .29
6.8.5 Report.29
6.9 Corrosion resistance of the dental amalgam .29
6.9.1 Principle .29
6.9.2 Test sample .29
6.9.3 Procedure .30
6.9.4 Treatment of results .30
6.9.5 Report.30
6.10 Length tolerance for the capsule . 31
6.10.1 Principle . 31
6.10.2 Test sample . 31
6.10.3 Apparatus . 31
6.10.4 Procedure . 31
6.10.5 Treatment of results . 31
6.10.6 Report. 31
7 Test report .32
8 Marking and labelling .32
8.1 Information . . 32
8.2 Labelling of the package for dental mercury . 33
8.3 Labelling of the outer surface of package or container used for shipping .33
8.4 Instructions for use .34
8.5 Precautionary notes .34
Bibliography .35
iv
ISO 20749:2023(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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of 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
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling
and restorative materials, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 20749:2017), which has been technically
revised.
The main changes are as follows:
— a requirement for corrosion resistance has been added;
— the roughness measure used to specify the finish required on working surfaces of test piece moulds
has been changed from R to R ;
k a
— an instruction to abrade lightly the ends of the cylindrical test pieces, if required, for removing flash
has been deleted;
— the requirement for early compression fracture stress has been altered; measurement of the value
is made at 2 h and not at 1 h;
— the thickness of the sheet specified for the mould to test for the consistency of dental amalgam from
capsule to capsule has been reduced to 2,5 mm;
— a 20 min cooling time before weighing has been added for the determination of the yield of dental
amalgam from a capsule;
— additional items of information have been added to each of the test reports;
v
ISO 20749:2023(E)
— the edition number of the manufacturer’s instructions and information, and the date of its
introduction have been added as a requirement to the manufacturer’s instructions;
— for each test method used to determine conformity to a requirement, a new subclause, “Principle”,
has been added in which a brief summary explains the method adopted;
— for each test method used to determine conformity to a requirement, a new subclause, “Report”, has
been added;
— a new Clause 7, “Report”, has been added which provides details of the evaluation that are to
accompany a statement of conformity to this document overall.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
vi
ISO 20749:2023(E)
Introduction
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazard are not included in this document and it is recommended that, for the assessment of
possible biological hazards, reference is made to ISO 10993-1 and ISO 7405.
vii
INTERNATIONAL STANDARD ISO 20749:2023(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 powder and dental mercury in quantities
suitable for the creation of a single dental restoration.
This document specifies the requirements and test methods for the capsule and the requirements for
packaging and marking.
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.
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 described in 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 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 6344-3, Coated abrasives — Determination and designation of grain size distribution — Part 3:
Microgrit sizes P240 to P5000
ISO 21920-2, Geometrical product specifications (GPS) — Surface texture: Profile — Part 2: Terms,
definitions and surface texture parameters
ISO 7488, Dentistry — Mixing machines for dental amalgam
ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the
manufacturer — Part 1: General requirements
ISO 23325:2020, Dentistry — Corrosion resistance of dental amalgam
Globally Harmonized System of Classification and Labelling of Chemicals (GHS). United Nations, New York
and Geneva, 9th Revised Edition, 2021, eISBN 978-92-1-005213-9
Recommendations on the Transport of Dangerous Goods, Model Regulations. United Nations, New York
st
and Geneva, 22 Edition (Vol.1), 2022, eISBN 978-92-1-005219-1
ISO 20749:2023(E)
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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
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 for dental restoration
[SOURCE: ISO 24234:2021, 3.1]
3.2
dental mercury
mercury supplied for use in the preparation of dental amalgam
[SOURCE: ISO 24234:2021, 3.2]
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 are separated by a barrier that is broken
immediately prior to mixing, allowing their contact. The capsule remains sealed until mixing has been completed.
[SOURCE: ISO 24234:2021, 3.3]
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
3.5
mechanically-activated capsule
pre-capsulated product (3.3) capsule in which force is applied to the ends of the capsule to rupture the
barrier between the dental amalgam alloy (3.1) powder and the dental mercury (3.2) for activation (3.6),
before placing the capsule in the mechanical mixing machine
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 either drops from the opened and
upended capsule, or is dislodged from the same when the rim of the open capsule is tapped lightly on a
hard surface
3.8
mixing machine for dental amalgam
DEPRECATED: amalgamator
electrically-powered mixing machine that operates using an oscillating action for mixing dental
amalgam alloy (3.1) powder and dental mercury (3.2) (in a capsule) to produce a dental amalgam
[SOURCE: ISO 24234:2021, 3.6, modified — the word "powder" has been added in the definition.]
ISO 20749:2023(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
The manufacturer shall declare every element that is present in a concentration greater than, or equal
to a mass fraction of 0,1 %. All alloying elements present in concentrations greater than a mass fraction
of 0,5 % shall be given by name with mass fraction values rounded to the nearest whole percentage
point. Alloying elements that are present in concentrations between a mass fraction of 0,1 % and 0,5 %
shall be named without a percentage value.
Test in accordance with 6.2.
The chemical composition shall comply with Table 1.
The total mass fraction for other elements present in concentrations greater than a mass fraction
of 0,01 % but below a mass fraction of 0,1 % that are not declared as alloying elements, shall not exceed
a mass fraction of 0,1 %.
Table 1 — Requirements for chemical composition of the dental amalgam alloy
Element Mass fraction
%
Silver ≥40
Tin ≤32
Copper ≤30
Indium ≤5
Palladium ≤1
Platinum ≤1
Zinc ≤2
Mercury ≤3
4.3 Large particles in the dental amalgam alloy powder
When conformity to 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 a mass fraction of 0,1 %.
4.4 Loss of mass from the capsule during mixing
When conformity to this requirement is determined in accordance with 6.4, the mean loss in mass of
dental mercury and dental amalgam alloy powder from a capsule (for the sample of 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 Yield of dental amalgam from the capsule
When conformity to this requirement is determined in accordance with 6.5, the mean mass of the pellet
of dental amalgam obtained from a capsule (for the sample of 15 capsules) shall not be less than 95,0 %
ISO 20749:2023(E)
of the sum of the manufacturer’s stated masses for dental mercury and dental amalgam alloy powder in
the capsule.
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 powder in the capsule.
There can 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 conformity to this requirement is determined in accordance with 6.6, the mean value for the
hardness of 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 from a sample of 10 capsules.
The content of one capsule is used to make one test piece only.
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 made on all 10 test
pieces.
4.7 Properties of the dental amalgam
4.7.1 General
The following properties are required, regarding creep, dimensional change during hardening and
compressive fracture stress.
Table 2 — Properties of the dental amalgam
Maximum Permitted dimensional Minimum compressive Minimum compressive
creep change during hardening fracture stress at 2 h fracture stress at 24 h
% % MPa MPa
2,0 –0,10 to +0,15 100 350
4.7.2 Creep
When conformity to 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.
4.7.3 Dimensional changes during hardening
When conformity to 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.
4.7.4 Compressive fracture stress at 2 h
When conformity to 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.
4.7.5 Compressive fracture stress at 24 h
When conformity to 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.
ISO 20749:2023(E)
4.8 Appearance of mixed dental amalgam before setting
When conformity to this requirement is determined in accordance with 6.8, the dental amalgam alloy
and dental mercury being 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 body
after packing is completed.
4.9 Corrosion resistance of the dental amalgam
When conformity to this requirement is determined in accordance with 6.9, the mean value (in newtons)
of 10 valid results for corrosion test pieces shall not be less than 80 % of the mean value (in newtons) of
10 valid results for control test pieces.
4.10 Length tolerance for the capsule
When conformity to this requirement is determined in accordance with 6.10, 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.
5 Sampling
Procure material in packages that have been produced for retail and that are from a single lot.
Procure a sufficient number of capsules to conduct all the testing needed to evaluate the alloy, the
capsules and to make the required number of dental amalgam test pieces, including the maximum
number of test pieces allowed to replace any that are rejected.
NOTE The number of capsules required depends on the masses of dental amalgam alloy powder 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 between production and receipt by the user is of concern.
Such a loss can be detected by visual examination of capsule and container surfaces at low power
magnification.
6.1.2 Test sample
All the containers holding capsules from the sample procured for testing the product for conformity to
all other requirements, 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.
ISO 20749:2023(E)
6.1.5 Treatment of the results
Record the observations.
6.1.6 Report
6.1.6.1 Test report
A test report shall be prepared. At least the following information shall be included:
a) name of the dental amalgam product and its lot number;
b) name and address of the manufacturer;
c) the International Standard used (i.e. ISO 20749:2023);
d) the test method used;
e) any irregularities in the test procedure;
f) if contamination is seen on the surface of a container, report this and the number of containers that
were contaminated;
g) if it is the capsule surface that is contaminated, report this and the number of capsules that were
contaminated;
h) name and address of the organization responsible for the testing (e.g. test house, university,
department of manufacturer);
i) date of testing.
6.1.6.2 Conformity
Report whether the product does or does not conform to the requirement for package and capsule
freedom from 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.
6.2.2 Test sample
Extract the dental amalgam alloy powder from one 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 instrument, with a sensitivity adequate to determine the
composition of the dental amalgam alloy for each of the elements declared by the manufacturer in
compliance with 4.2.
NOTE Inductively coupled plasma atomic emission spectroscopy (ICP-AES) is an example of a suitable
analytical procedure.
ISO 20749:2023(E)
6.2.4 Procedure
Determine the composition of the dental amalgam alloy for the elements declared by the manufacturer
in compliance with 4.2. Other elements can be detected during the analysis, being undeclared or
impurities. Determine the concentration of each of these as a mass fraction (percentage).
6.2.5 Treatment of the results
Record all the mass fraction percentages of alloying elements detected in concentrations greater than a
mass fraction of 0,
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