SIST EN ISO 3107:2023

SLOVENSKI STANDARD
01-januar-2023
Nadomešča:
SIST EN ISO 3107:2011
Zobozdravstvo - Cementi iz cinkovega oksida z evgenolom in iz cinkovega oksida
brez evgenola (ISO 3107:2022)
Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements (ISO
3107:2022)
Zahnheilkunde - Zinkoxid-Eugenol und Zinkoxid-Nichteugenol-Zemente (ISO 3107:2022)
Médecine bucco-dentaire - Ciments à l’oxyde de zinc-eugénol et à l'oxyde de zinc sans
eugénol (ISO 3107:2022)
Ta slovenski standard je istoveten z: EN ISO 3107:2022
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 3107
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2022
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 3107:2011
English Version
Dentistry - Zinc oxide-eugenol cements and non-eugenol
zinc oxide cements (ISO 3107:2022)
Médecine bucco-dentaire - Ciments à l'oxyde de zinc- Zahnheilkunde - Zinkoxid-Eugenol und Zinkoxid-
eugénol et à l'oxyde de zinc sans eugénol (ISO Nichteugenol-Zemente (ISO 3107:2022)
3107:2022)
This European Standard was approved by CEN on 16 September 2022.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3107:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 3107:2022) 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 April 2023, and conflicting national standards shall be
withdrawn at the latest by April 2023.
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 3107:2011.
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 3107:2022 has been approved by CEN as EN ISO 3107:2022 without any modification.

INTERNATIONAL ISO
STANDARD 3107
Fifth edition
2022-09
Dentistry — Zinc oxide-eugenol
cements and non-eugenol zinc oxide
cements
Médecine bucco-dentaire — Ciments à l’oxyde de zinc-eugénol et à
l'oxyde de zinc sans eugénol
Reference number
ISO 3107:2022(E)
ISO 3107:2022(E)
© 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
ISO 3107:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 S c op e . 1
2 Nor m at i ve r ef er enc e s . 1
3 Terms and definitions . 1
4 Classification . 1
5 R e qu i r ement s . 1
5.1 P erformance requirements . 1
5.2 B iocompatibility . 2
6 S a mpl i n g . 2
7 Te s t me t ho d s . 2
7.1 P reparation of test specimens . 2
7.1.1 A mbient c ond it ion s . 2
7.1.2 P rocedure for mixing . 2
7.2 D etermination of setting time . 2
7.2.1 A pparatus . 2
7.2.2 Procedure . 3
7.2.3 Treatment of results . 3
7.3 D etermination of compressive strength . 3
7.3.1 Apparatus . 3
7.3.2 Preparation of test specimens . 5
7.3.3 P rocedure . 5
7.3.4 Treatment of results . 6
7.4 D etermination of film thickness . 6
7.4.1 Apparatus . 6
7.4.2 Procedure . 6
7.4.3 T reatment of results . 6
7.5 D etermination of acid-soluble arsenic fraction . 7
7.5.1 Preparation of test sample . 7
7.5.2 P rocedure . 8
7.5.3 C ompliance . 8
8 Marking, labelling and packaging .8
8.1 Packaging . 8
8.2 M arking and instructions for use . 8
Bibliography .10
iii
ISO 3107:2022(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 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 fifth edition cancels and replaces the fourth edition (ISO 3107:2011), of which it constitutes a
minor revision.
— replace “zinc oxide/eugenol cement” with “zinc oxide-eugenol cement”,
— replace “non-eugenol cement” with “non-eugenol zinc oxide cement”, and
— replace “aromatic oils” with “oil(s) other than eugenol”.
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.
iv
ISO 3107:2022(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazard are not included
in this document, but it is intended that in assessing possible biological or toxicological hazards,
reference be made to ISO 10993-1 and ISO 7405.
v
INTERNATIONAL STANDARD ISO 3107:2022(E)
Dentistry — Zinc oxide-eugenol cements and non-eugenol
zinc oxide cements
1 S cope
This document specifies requirements for zinc oxide-eugenol cements suitable for use in restorative
dentistry for temporary cementation, for bases and as temporary restorations.
This document also specifies requirements for non-eugenol zinc oxide cements containing zinc oxide
and oil(s) other than eugenol for temporary cementati
...