SIST EN ISO 3107:2023
(Main)Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements (ISO 3107:2022)
Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements (ISO 3107:2022)
ISO 3107:2011 specifies requirements for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations.
ISO 3107:2011 also specifies requirements for non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation.
Zahnheilkunde - Zinkoxid-Eugenol und Zinkoxid-Nichteugenol-Zemente (ISO 3107:2022)
Dieses Dokument gilt für Zinkoxid-Eugenolzemente, die in der restaurativen Zahnheilkunde für provisorische (temporäre) Befestigungen, Unterfüllungen und provisorische Verschlüsse geeignet sind.
Dieses Dokument gilt auch für eugenolfreie Zinkoxidzemente, die Zinkoxid und Öl(e) außer Eugenol für provisorische Befestigungen enthalten.
Médecine bucco-dentaire - Ciments à l’oxyde de zinc-eugénol et à l'oxyde de zinc sans eugénol (ISO 3107:2022)
L'ISO 3107:2011 spécifie les exigences des ciments non aqueux à base d'oxyde de zinc‑eugénol, destinés à être utilisés en médecine bucco-dentaire restauratrice pour scellement temporaire, fonds de cavité et bases, et comme restauration temporaire.
L'ISO 3107:2011 spécifie également les exigences des ciments sans eugénol contenant de l'oxyde de zinc et des huiles aromatiques destinés à un scellement temporaire.
Zobozdravstvo - Cementi iz cinkovega oksida z evgenolom in iz cinkovega oksida brez evgenola (ISO 3107:2022)
Standard ISO 3107:2011 določa zahteve za cemente iz cinkovega oksida z evgenolom na vodni osnovi, ki so primerni za uporabo v restavracijskem zobozdravstvu za začasno cementiranje, za podlage in kot začasne restavracije.
Standard ISO 3107:2011 določa tudi zahteve za cemente brez evgenola, ki vsebujejo cinkov oksid in aromatična olja ter so primerni za začasno cementiranje.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 3107:2023
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
SIST EN ISO 3107:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 3107:2023
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SIST EN ISO 3107:2023
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.
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SIST EN ISO 3107:2023
EN ISO 3107:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 3107:2023
EN ISO 3107:2022 (E)
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.
3
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SIST EN ISO 3107:2023
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SIST EN ISO 3107:2023
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 2022
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SIST EN ISO 3107:2023
ISO 3107:2022(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
© ISO 2022 – All rights reserved
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SIST EN ISO 3107:2023
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 2022 – All rights reserved
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SIST EN ISO 3107:2023
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 2022 – All rights reserved
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SIST EN ISO 3107:2023
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
© ISO 2022 – All rights reserved
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SIST EN ISO 3107:2023
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SIST EN ISO 3107:2023
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
...
SLOVENSKI STANDARD
oSIST prEN ISO 3107:2022
01-julij-2022
Zobozdravstvo - Cementi iz cinkovega oksida z evgenolom in cinkovega oksida
brez evgenola (ISO/FDIS 3107:2022)
Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO/FDIS
3107:2022)
Zahnheilkunde - Zinkoxid-Eugenol und Zinkoxid-Nichteugenol-Zemente (ISO/FDIS
3107:2022)
Médecine bucco-dentaire - Ciments dentaires à base d'oxyde de zinc-eugénol et à base
d'oxyde de zinc sans eugénol (ISO/FDIS 3107:2022)
Ta slovenski standard je istoveten z: prEN ISO 3107
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 3107:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 3107:2022
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oSIST prEN ISO 3107:2022
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 3107
ISO/TC 106/SC 1
Dentistry — Zinc oxide/eugenol
Secretariat: AFNOR
cements and zinc oxide/non-eugenol
Voting begins on:
2022-05-23 cements
Voting terminates on:
Médecine bucco-dentaire — Ciments dentaires à base d'oxyde de zinc-
2022-08-15
eugénol et à base d'oxyde de zinc sans eugénol
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 3107:2022(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2022
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oSIST prEN ISO 3107:2022
ISO/FDIS 3107:2022(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
© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 3107:2022
ISO/FDIS 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 pp a r at u s . 2
7. 2 . 2 P r o c e du r e . 3
7.2.3 Treatment of results . 3
7.3 D etermination of compressive strength . 3
7. 3 .1 A pp a r at u s . 3
7.3.2 Preparation of test specimens . 5
7. 3 . 3 P r o c e du r e . 5
7.3.4 Treatment of results . 6
7.4 D etermination of film thickness . 6
7.4 .1 A pp a r at u s . 6
7.4 . 2 P r o c e du r e . 6
7.4.3 T reatment of results . 6
7.5 Determination of acid-soluble arsenic fraction . 7
7.5.1 Preparation of test sample . 7
7. 5 . 2 P r o ce du r e . 8
7. 5 . 3 C ompl i a nce . 8
8 Marking, labelling and packaging .8
8.1 Packaging . 8
8.2 M arking and instructions for use . 8
Bibliography .10
iii
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
oSIST prEN ISO 3107:2022
ISO/FDIS 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 2022 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 3107:2022
ISO/FDIS 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
© ISO 2022 – All rights reserved
---------------------- Page: 7 ----------------------
oSIST prEN ISO 3107:2022
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oSIST prEN ISO 3107:2022
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 3107:2022(E)
Dentistry — Zinc oxide/eugenol cements and zinc oxide/
non-eugenol 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 cementation.
2 Normat ive 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 1942, Dentistry — Vocabulary
ISO 2590, General method for the determination of arsenic — Silver diethyldithiocarbamate photometric
method
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 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/
4 Classification
For the purposes of this document, the following classification for cements is used, based on their
intended use:
a) Type I: for temporary cementation;
b) Type II: for bases and temporary restorations.
5 Requirements
5.1 Performance requirements
When tested in accordance with the appropriate test methods specified in Clause 7, Type I and Type II
cements shall comply with the performance requirements specified in Table 1.
1
© ISO 2022 – All rights reserved
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oSIST prEN ISO 3107:2022
ISO/FDIS 3107:2022(E)
Table 1 — Requirements
Type Setting time at 37 °C Compressive strength Film thickness Acid-soluble arsenic
at 24 h mass fraction
a
min MPa µm mg/kg
minimum maximum minimum maximum maximum maximum
Type I 1,5 10 35 25 2
Type II 1,5 10 5 N/A 2
N/A: not applica
...
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