SIST EN ISO 3107:2005
(Main)Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements (ISO 3107:2004)
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements (ISO 3107:2004)
ISO 3107:2004 specifies the requirements and performance test methods for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for permanent cementation, for cavity liners and bases and as temporary restorations.
ISO 3107:2004 is also applicable to non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation.
Zahnheilkunde - Zinkoxideugenolzemente und eugenolfreie Zinkoxidzemente (ISO 3107:2004)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für die Leistung von nicht auf Wasser basierenden Zinkoxideugenolzementen fest, die in der restaurativen Zahnheilkunde zur Anwendung für provisorische Befestigungen, für permanente Befestigungen und für Unterfüllungen von Kavitäten sowie für provisorische Füllungen vorgesehen sind.
Diese Internationale Norm gilt auch für eugenolfreie Zemente, die Zinkoxid und aromatische Öle enthalten, und die für provisorische Befestigungen und Füllungen geeignet sind.
Art dentaire - Ciments dentaires a base d'oxyde de zinc-eugénol et a base d'oxyde de zinc sans eugénol (ISO 3107:2004)
L'ISO 3107:2005 spécifie les exigences et les méthodes d'essai de performance des ciments non aqueux à base d'oxyde de zinc-eugénol, destinés à être utilisés en médecine dentaire restauratrice pour obturation temporaire, obturation permanente, pour les fonds de cavité et les bases et comme restauration temporaire.
L'ISO 3107:2005 s'applique également aux ciments sans eugénol contenant de l'oxyde de zinc et des huiles aromatiques destinées à une obturation temporaire.
Zobozdravstvo - Cementi iz cinkovega oksida/eugenola in cinkovega oksida brez eugenola (ISO 3107:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 3107:2005
01-marec-2005
Zobozdravstvo - Cementi iz cinkovega oksida/eugenola in cinkovega oksida brez
eugenola (ISO 3107:2004)
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements (ISO 3107:2004)
Zahnheilkunde - Zinkoxideugenolzemente und eugenolfreie Zinkoxidzemente (ISO
3107:2004)
Art dentaire - Ciments dentaires a base d'oxyde de zinc-eugénol et a base d'oxyde de
zinc sans eugénol (ISO 3107:2004)
Ta slovenski standard je istoveten z: EN ISO 3107:2004
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 3107:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 3107:2005
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SIST EN ISO 3107:2005
EUROPEAN STANDARD
EN ISO 3107
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2004
ICS 11.060.10 Supersedes EN 23107:1991
English version
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol
cements (ISO 3107:2004)
Art dentaire - Ciments dentaires à base d'oxyde de zinc- Zahnheilkunde - Zinkoxideugenolzemente und eugenolfreie
eugénol et à base d'oxyde de zinc sans eugénol (ISO Zinkoxidzemente (ISO 3107:2004)
3107:2004)
This European Standard was approved by CEN on 23 September 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3107:2004: E
worldwide for CEN national Members.
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SIST EN ISO 3107:2005
EN ISO 3107:2004 (E)
Foreword
This document (EN ISO 3107:2004) 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 2005, and conflicting national
standards shall be withdrawn at the latest by April 2005.
This document supersedes EN 23107:1991.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 3107:2004 has been approved by CEN as EN ISO 3107:2004 without any
modifications.
2
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SIST EN ISO 3107:2005
INTERNATIONAL ISO
STANDARD 3107
Third edition
2004-10-01
Dentistry — Zinc oxide/eugenol and zinc
oxide/non-eugenol cements
Art dentaire — Ciments dentaires à base d'oxyde de zinc-eugénol et à
base d'oxyde de zinc sans eugénol
Reference number
ISO 3107:2004(E)
©
ISO 2004
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SIST EN ISO 3107:2005
ISO 3107:2004(E)
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ii © ISO 2004 – All rights reserved
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SIST EN ISO 3107:2005
ISO 3107:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Classification. 1
4 Requirements . 2
4.1 Performance requirements . 2
4.2 Biocompatibility . 2
5 Sampling . 2
6 Test methods. 2
6.1 Preparation of test specimens. 2
6.2 Determination of setting time . 2
6.3 Determination of compressive strength. 4
6.4 Determination of film thickness . 6
6.5 Determination of disintegration. 8
6.6 Determination of acid-soluble arsenic content. 12
7 Packaging and marking. 12
7.1 Packaging . 12
7.2 Manufacturer's instructions. 12
7.3 Marking of containers. 13
7.4 Capsule or single-dose container . 13
Bibliography . 14
© ISO 2004 – All rights reserved iii
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SIST EN ISO 3107:2005
ISO 3107:2004(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 third edition cancels and replaces the second edition (ISO 3107:1988), which has been technically
revised, including extensive revision and simplification of the classification system, and removal of the
disintegration limit as a requirement for temporary cements.
iv © ISO 2004 – All rights reserved
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SIST EN ISO 3107:2005
ISO 3107:2004(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard, but it is recommended that, in assessing possible biological or toxicological hazards,
reference be made to ISO 10993-1 and ISO 7405.
© ISO 2004 – All rights reserved v
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SIST EN ISO 3107:2005
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SIST EN ISO 3107:2005
INTERNATIONAL STANDARD ISO 3107:2004(E)
Dentistry — Zinc oxide/eugenol and zinc oxide/non-eugenol
cements
1 Scope
This International Standard specifies the requirements and performance test methods for non-water-based
zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for permanent
cementation, for cavity liners and bases and as temporary restorations.
This International Standard is also applicable to 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 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, Data elements and interchange formats — Information interchange — Representation of dates and
times
3 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;
1) Class 1: setting cement;
2) Class 2: non-setting cement.
b) Type II: for permanent cementation;
c) Type III: for bases and temporary restorations;
d) Type IV: for cavity liners.
© ISO 2004 – All rights reserved 1
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SIST EN ISO 3107:2005
ISO 3107:2004(E)
4 Requirements
4.1 Performance requirements
When tested in accordance with the appropriate test methods specified in Clause 6, cements shall comply
with the performance requirements specified in Table 1.
Table 1 — Requirements
Setting time at 37 °C Compressive Disintegration Film Acid-soluble
Type and Class strength at 24 h after 24 h thickness arsenic content
min MPa % (mass fraction) µm mg/kg
min. max. min. max. max. max. max.
Type I, Class 1 4 10 35 N/A* 25 2
Type I, Class 2 Penetration at 1 h N/A* N/A* N/A* 25 2
Type II 4 10 35 1,5 25 2
Type III 3 10 25 1,5 N/A* 2
Type IV 4 10 5 1,5 N/A* 2
N/A* not applicable.
4.2 Biocompatibility
Guidance on biocompatibility is given in ISO 10993-1 and ISO 7405 (see Bibliography).
5 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.
6 Test methods
6.1 Preparation of test specimens
Prepare the test material in accordance with the manufacturer's instructions (7.2)
Prepare all specimens at (23 ± 1) °C and a relative humidity of (50 ± 5) %. Before the start of mixing, condition
the test samples and apparatus in these conditions for at least 1 h.
Prepare the cement according to the manufacturer's instructions. Mix sufficient cement to ensure that the
preparation of each specimen is completed from one mix. Prepare a fresh mix for each specimen.
6.2 Determination of setting time
6.2.1 Apparatus
6.2.1.1 Cabinet, capable of being maintained at a temperature of (37 ± 1) °C and a relative humidity not
less than 95 %.
6.2.1.2 Indenter needle.
2 © ISO 2004 – All rights reserved
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SIST EN ISO 3107:2005
ISO 3107:2004(E)
6.2.1.2.1 For Type I Class 1, Type II and Type III materials, an indenter needle of mass (400 ± 2) g with a
tip which is cylindrical for a distance of approximately 5 mm, which has a flat end of diameter (1,0 ± 0,1) mm.
6.2.1.2.2 For Type I Class 2 and Type IV materials, an indenter needle similar to that of 6.2.1.2.1 but of
mass (100,0 ± 0,5) g and having a flat end of diameter (2,0 ± 0,1) mm.
6.2.1.3 Mould, made of non-corrodible metal, consisting of a rectangular plate with a circular hole
conforming to the dimensions given in Figure 1.
Dimensions in millimetres
Figure 1 — Mould for use in determination of setting time
6.2.1.4 Metal block, of minimum dimensions 8 mm × 20 mm × 10 mm.
6.2.1.5 Flat glass plate, approximately 1 mm thick (for example, a microscope slide).
6.2.2 Procedure
Condition the metal block (6.2.1.4) and indenter needle (6.2.1.2) in the cabinet (6.2.1.1) at (37 ± 1) °C.
Place the metal mould (6.2.1.3), conditioned at (23 ± 1) °C, on a flat glass plate (6.2.1.5) and fill with the
cement to give a level top surface.
At (120 ± 10) s after the start of mixing for
...
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