EN ISO 13897:2018

SLOVENSKI STANDARD
01-maj-2018
1DGRPHãþD
SIST EN ISO 13897:2004
Zobozdravstvo - Kapsule za ponovno uporabo zobnega amalgama (ISO
13897:2018)
Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)
Zahnheilkunde - Wiederverwendbare Mischkapseln für zahnärztliches Amalgam (ISO
13897:2018)
Art dentaire - Capsules réutilisables pour mélanger amalgame (ISO 13897:2018)
Ta slovenski standard je istoveten z: EN ISO 13897:2018
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 13897
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2018
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 13897:2004
English Version
Dentistry - Dental amalgam reusable mixing-capsules (ISO
13897:2018)
Médecine bucco-dentaire - Capsules de mélange Zahnheilkunde - Wiederverwendbare Mischkapseln für
réutilisables pour amalgame dentaire (ISO zahnärztliches Amalgam (ISO 13897:2018)
13897:2018)
This European Standard was approved by CEN on 2 February 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 13897:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 13897:2018) 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 August 2018, and conflicting national standards shall
be withdrawn at the latest by August 2018.
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 13897:2004.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13897:2018 has been approved by CEN as EN ISO 13897:2018 without any modification.

INTERNATIONAL ISO
STANDARD 13897
Second edition
2018-02
Dentistry — Dental amalgam reusable
mixing-capsules
Médecine bucco-dentaire — Capsules de mélange réutilisables pour
amalgame dentaire
Reference number
ISO 13897:2018(E)
©
ISO 2018
ISO 13897:2018(E)
© ISO 2018
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
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
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Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 13897:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 1
4.1 Dimensions . 1
4.1.1 Length tolerance . 1
4.1.2 Diameter tolerance . 2
4.2 Loss of mass from the mixing-capsule during mixing. 2
4.3 Retention of dental amalgam in the mixing-capsule . 2
5 Sampling . 2
6 Measurements and test methods . 2
6.1 Dimensions . 2
6.1.1 Apparatus . 2
6.1.2 Test sample . 2
6.1.3 Procedure . 2
6.1.4 Report . 3
6.2 Loss of mass from the mixing-capsule during mixing. 3
6.2.1 Principle . 3
6.2.2 Test sample . 3
6.2.3 Apparatus . 3
6.2.4 Test procedure . 4
6.2.5 Expression of the results . 5
6.2.6 Report . 5
6.3 Retention of dental amalgam in the mixing-capsule . 5
6.3.1 Principle . 5
6.3.2 Test sample . 6
6.3.3 Apparatus . 6
6.3.4 Test procedure . 6
6.3.5 Expression of the results . 7
6.3.6 Additional testing . 8
6.3.7 Report . 8
7 Labelling . 8
Bibliography . 9
ISO 13897:2018(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 6, Dental
equipment.
This second edition cancels and replaces the first edition (ISO 13897:2003) including Technical
Corrigendum 1 (ISO 13897:2003/Cor.1:2003), which has been technically revised.
The main changes compared to the previous edition are as follows:
— the scope has been revised and is now restricted to dental amalgam reusable mixing-capsules;
— classification into two types has been deleted;
— labelling requirements have been updated.
— requirements for single-use capsules are now within the scope of ISO 20749:2017, these being:
— the requirement for surface contamination of the package and the capsule for pre-capsulated
dental amalgam alloy products;
— loss of mass during mixing from single-use capsules;
— the requirement for containers in which single-use capsules are supplied to prevent spillage of
dental mercury leaking from faulty or damaged single-use capsules;
— labelling requirements for pre-capsulated dental amalgam products;
— manufacturer’s instructions regarding conditions of storage and the disposal of single-use
capsules in pre-capsulated dental amalgam products.
iv © ISO 2018 – All rights reserved

ISO 13897:2018(E)
Introduction
In order to produce dental amalgam, an electrically-powered mixing machine, as described in ISO 7488
is used for mixing dental amalgam alloy powder with dental mercury. In addition, a removable mixing-
capsule is used to contain the dental amalgam alloy and the dental mercury during the mixing process.
NOTE Traditionally, the mixing machine for dental amalgam has been called an amalgamator. The latter is
now a deprecated term.
INTERNATIONAL STANDARD ISO 13897:2018(E)
Dentistry — Dental amalgam reusable mixing-capsules
1 Scope
This document specifies the requirements for reusable mixing-capsules intended to contain dental
amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the
test methods used to determine conformity to these requirements.
NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not
dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitute 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 1942, Dentistry — Vocabulary
ISO 7488, Dentistry — Mixing machines for dental amalgam
ISO 24234:2015, Dentistry — Dental amalgam
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
— IEC
...