EN ISO 3107:2011
(Main)Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO 3107:2011)
Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO 3107:2011)
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-Eugenolzemente und eugenolfreie Zinkoxidzemente (ISO 3107:2011)
Diese Internationale Norm gilt für Zinkoxid-Eugenolzemente, die nicht auf Wasser basieren, und die in der
restaurativen Zahnheilkunde für provisorische (temporäre) Befestigungen, Unterfüllungen und provisorische
Verschlüsse geeignet sind.
Diese Internationale Norm gilt auch für eugenolfreie Zemente, die Zinkoxid und aromatische Öle enthalten,
und die für provisorische Befestigungen geeignet sind.
Médecine bucco-dentaire - Ciments dentaires à base d'oxyde de zinc-eugénol et à base d'oxyde de zinc sans eugénol (ISO 3107:2011)
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 cinkovega oksida brez evgenola (ISO 3107:2011)
Ta mednarodni standard določa zahteve za nevodno zasnovane cemente iz cinkovega oksida z evgenolom, primerne za uporabo v restavrativnem zobozdravstvu za začasno cementacijo, za baze in začasne restavracije. Ta mednarodni standard prav tako določa zahteve za cemente brez evegenola, ki vsebujejo cinkov oksid in aromatična olja, primerne za začasno cementacijo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2011
1DGRPHãþD
SIST EN ISO 3107:2005
SIST EN ISO 3107:2005/AC:2006
Zobozdravstvo - Cementi iz cinkovega oksida z evgenolom in cinkovega oksida
brez evgenola (ISO 3107:2011)
Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO
3107:2011)
Zahnheilkunde - Zinkoxideugenolzemente und eugenolfreie Zinkoxidzemente (ISO
3107:2011)
Art dentaire - Ciments dentaires à base d'oxyde de zinc-eugénol et à base d'oxyde de
zinc sans eugénol (ISO 3107:2011)
Ta slovenski standard je istoveten z: EN ISO 3107:2011
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 3107
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2011
ICS 11.060.10 Supersedes EN ISO 3107:2004
English Version
Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-
eugenol cements (ISO 3107:2011)
Médecine bucco-dentaire - Ciments dentaires à base Zahnheilkunde - Zinkoxid-Eugenolzemente und
d'oxyde de zinc-eugénol et à base d'oxyde de zinc sans eugenolfreie Zinkoxidzemente (ISO 3107:2011)
eugénol (ISO 3107:2011)
This European Standard was approved by CEN on 28 February 2011.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3107:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
The text of ISO 3107:2011 has been prepared by Technical Committee ISO/TC 106 "Dentistry" of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 3107:2011 by
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 September 2011, and conflicting national standards shall be
withdrawn at the latest by September 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 3107:2004.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 3107:2011 has been approved by CEN as a EN ISO 3107:2011 without any modification.
INTERNATIONAL ISO
STANDARD 3107
Fourth edition
2011-03-01
Dentistry — Zinc oxide/eugenol cements
and zinc oxide/non-eugenol cements
Médecine bucco-dentaire — Ciments dentaires à base d'oxyde de zinc-
eugénol et à base d'oxyde de zinc sans eugénol
Reference number
ISO 3107:2011(E)
©
ISO 2011
ISO 3107:2011(E)
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ii © ISO 2011 – All rights reserved
ISO 3107:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Classification .1
5 Requirements.1
5.1 Performance requirements.1
5.2 Biocompatibility.2
6 Sampling .2
7 Test methods .2
7.1 Preparation of test specimens .2
7.2 Determination of setting time.2
7.3 Determination of compressive strength .3
7.4 Determination of film thickness.6
7.5 Determination of acid-soluble arsenic fraction.8
8 Marking, labelling and packaging.8
8.1 Packaging.8
8.2 Marking and instructions for use.8
Bibliography.10
ISO 3107:2011(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 3107 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
This fourth edition cancels and replaces the third edition (ISO 3107:2004), which has been technically revised.
It also incorporates the Technical Corrigendum ISO 3107:2004/Cor.1:2006.
The main changes are that the
a) classification types have been consolidated into two,
b) compressive strength limit has been reduced to reflect materials in current use,
c) text on interpretation of compressive test results has been modified, and
d) lower setting time limit has been lowered to reflect materials in current use.
iv © ISO 2011 – All rights reserved
ISO 3107:2011(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard, but it is intended that in assessing possible biological or toxicological hazards,
reference be made to ISO 10993-1 and ISO 7405.
INTERNATIONAL STANDARD ISO 3107:2011(E)
Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-
eugenol cements
1 Scope
This International Standard 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.
This International Standard also specifies requirements for non-eugenol cements containing zinc oxide and
aromatic oils suitable for temporary cementation.
2 Normative references
The following referenced documents are indispensable for the application 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, Water for analytical laboratory use — Specification and test methods
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 apply.
4 Classification
For the purposes of this International Standard, 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.
ISO 3107:2011(E)
Table 1 — Requirements
Type Setting time at 37 °C Compressive strength Film thickness Acid-soluble
at 24 h arsenic mass
fraction
a
min MPa µm
mg/kg
min. max. min. max. max. max.
Type I 1,5 10 35 25 2
Type II 1,5 10 5 N/A 2
N/A: not applicable
a
mg/kg is the equivalent of ppm; ppm is a deprecated unit.
5.2 Biocompatibility
For guidance on biocompatibility, see ISO 10993-1 and ISO 7405.
6 Sampling
The test sample shall consist of packages prepared for retail sale from the same batch containing enough
material to carry out the specified tasks plus an allowance for repeats. 50 g should be sufficient.
7 Test methods
7.1 Prepara
...
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