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)

General Information

Status
Published
Publication Date
11-Jul-2023
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
12-Jul-2023
Completion Date
12-Jul-2023

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SLOVENSKI STANDARD
oSIST prEN ISO 20749:2022
01-april-2022
Zobozdravstvo - Pripravljeni zobni amalgam (ISO/DIS 20749:2022)
Dentistry - Pre-capsulated dental amalgam (ISO/DIS 20749:2022)
Zahnheilkunde – Dentalamalgam in Kapseln (ISO/DIS 20749:2022)
Médecine bucco-dentaire - Amalgame dentaire en capsules prédosées (ISO/DIS
20749:2022)
Ta slovenski standard je istoveten z: prEN ISO 20749
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 20749:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 20749:2022

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oSIST prEN ISO 20749:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20749
ISO/TC 106/SC 1 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2022-02-03 2022-04-28
Dentistry — Pre-capsulated dental amalgam
Médecine bucco-dentaire — Amalgame dentaire encapsulée
ICS: 11.060.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 20749:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 20749:2022
ISO/DIS 20749:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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oSIST prEN ISO 20749:2022
ISO/DIS 20749:2022(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
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 . 4
4.5 The yield of dental amalgam from the capsule . 4
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 . 5
4.7.5 Compressive fracture stress at 24 h . 5
4.8 Appearance of the 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 . 6
6.1.4 Procedure . 6
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 . 7
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. 9
6.4 Loss of mass of 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. 10
6.4.5 Treatment of the results . 10
6.4.6 Report. 11
6.5 Yield of amalgam from the capsule . 11
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oSIST prEN ISO 20749:2022
ISO/DIS 20749:2022(E)
6.5.1 Principle . 11
6.5.2 Test sample . 11
6.5.3 Apparatus . 11
6.5.4 Test Procedure . 12
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 . 15
6.6.6 Microhardness measurement . 15
6.6.7 Treatment of the results . 16
6.6.8 Report. 16
6.7 Properties of the dental amalgam . 17
6.7.1 Principle . 17
6.7.2 Mould for the preparation of test test-pieces for determining creep,
dimensional change during hardening and compressive fracture stress . 17
6.7.3 Test sample . 20
6.7.4 Test-piece production . 20
6.7.5 Procedure for the determination of creep. 22
6.7.6 Procedure for the determination of dimensional change during hardening .23
6.7.7 Procedure for the determination of compressive fracture stress .25
6.8 Appearance of the mixed dental amalgam before setting . 27
6.8.1 Principle . 27
6.8.2 Apparatus . 27
6.8.3 Procedure . 27
6.8.4 Treatment of the results .28
6.8.5 Report .28
6.9 Corrosion resistance of the dental amalgam .28
6.9.1 Principle .28
6.9.2 Test sample .28
6.9.3 Procedure .29
6.9.4 Treatment of results .29
6.9.5 Report.29
6.10 Length tolerance for the capsule . 30
6.10.1 Principle . 30
6.10.2 Test sample .30
6.10.3 Apparatus .30
6.10.4 Procedure .30
6.10.5 Treatment of results .30
6.10.6 Report.30
7 Report .31
8 Marking and labelling .31
8.1 Information . . 31
8.2 Labelling of the package for dental mercury . 32
8.3 Labelling of the outer surface of package or container used for shipping . 32
8.4 Manufacturer’s instructions . 33
8.5 Precautionary notes . 33
Bibliography .34
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oSIST prEN ISO 20749:2022
ISO/DIS 20749:2022(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: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling
and Restorative Materials.
The Scope of this document is restricted to dental amalgam products marketed in pre-capsulated
form, alone. Other products intended for use in the 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, 2021.
This second edition cancels and replaces the first edition (ISO 20749, 2017), which has been technically
revised.
The main changes compared with the previous edition 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 strength 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 is reduced to 2,5 mm;
— when determining the yield of dental amalgam from a capsule, a 20 min cooling time before weighing
has been added;
— additional items of information have been added to each of the test reports;
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oSIST prEN ISO 20749:2022
ISO/DIS 20749:2022(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 sub-clause, “Principle”,
has been added in which a brief summary is present to explain the method adopted;
— for each test method used to determine conformity to a requirement, a new sub-clause, “Report”,
has been added;
— a new Clause, “7 Report”, has been added. It 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.
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oSIST prEN ISO 20749:2022
ISO/DIS 20749:2022(E)
Introduction
This is the second edition of ISO 20749, Dentistry — Pre-capsulated dental amalgam.
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 should be made to ISO 10993 and ISO 7405.
vii
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oSIST prEN ISO 20749:2022

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oSIST prEN ISO 20749:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 20749:2022(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.
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 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 4287, Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions
and surface texture parameters
ISO 7488, Dentistry — Mixing machines for dental amalgam
ISO 15223-1:2016, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 23325, Dentistry — Corrosion resistance of dental amalgam
Globally Harmonized System of Classification and Labelling of Chemicals (GHS). United Nations, New York
th
and Geneva, 8 Edition, 2019, eISBN 978-92-1-004083-9
UN Recommendations on the Transport of Dangerous Goods, Model Regulations. United Nations, New York
st
and Geneva, 21 Edition, 2019, eISBN 978-92-1-004112-6
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:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
1
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oSIST prEN ISO 20749:2022
ISO/DIS 20749:2022(E)
— 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:
...

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