SIST EN ISO 6874:2005
(Main)Dentistry - Polymer-based pit and fissure sealants (ISO 6874:2005)
Dentistry - Polymer-based pit and fissure sealants (ISO 6874:2005)
ISO 6874:2005 specifies requirements and test methods for polymer-based materials intended for sealing pits and fissures in teeth.
ISO 6874:2005 covers both self-cured and external-energy-activated materials.
Zahnheilkunde - Kunststoffe zur Fissurenversiegelung (ISO 6874:2005)
In dieser Internationalen Norm werden Anforderungen an und Prüfverfahren für Kunststoffe zur Fissurenversiegelung in Zähnen festgelegt.
Diese Internationale Norm gilt sowohl für selbsthärtende Werkstoffe als auch für Werkstoffe, die durch eine externe Energiequelle aktiviert werden.
Art dentaire - Produits dentaires a base de polymeres pour ccomblement des puits et fissures (ISO 6874:2005)
L'ISO 6874:2005 fixe les exigences et spécifie les méthodes d'essai des produits à base de polymères destinés au comblement des puits et fissures dans les dents.
L'ISO 6874:2005 couvre à la fois les produits autopolymérisables et les produits activés par une source externe d'énergie.
Zobozdravstvo - Tesnilna sredstva na osnovi polimerov za otiske in razpoke (ISO 6874:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 6874:2005
01-december-2005
1DGRPHãþD
SIST EN 26874:2000
Zobozdravstvo - Tesnilna sredstva na osnovi polimerov za otiske in razpoke (ISO
6874:2005)
Dentistry - Polymer-based pit and fissure sealants (ISO 6874:2005)
Zahnheilkunde - Kunststoffe zur Fissurenversiegelung (ISO 6874:2005)
Art dentaire - Produits dentaires a base de polymeres pour ccomblement des puits et
fissures (ISO 6874:2005)
Ta slovenski standard je istoveten z: EN ISO 6874:2005
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 6874:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 6874:2005
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SIST EN ISO 6874:2005
EUROPEAN STANDARD
EN ISO 6874
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2005
ICS 11.060.10 Supersedes EN 26874:1992
English Version
Dentistry - Polymer-based pit and fissure sealants (ISO
6874:2005)
Art dentaire - Produits dentaires à base de polymères pour Zahnheilkunde - Versiegelungskunststoffe für Grübchen
ccomblement des puits et fissures (ISO 6874:2005) und Fissuren (ISO 6874:2005)
This European Standard was approved by CEN on 1 August 2005.
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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6874:2005: E
worldwide for CEN national Members.
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SIST EN ISO 6874:2005
EN ISO 6874:2005 (E)
Foreword
This document (EN ISO 6874:2005) 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 February 2006, and conflicting national
standards shall be withdrawn at the latest by February 2006.
This document supersedes EN 26874:1992.
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 6874:2005 has been approved by CEN as EN ISO 6874:2005 without any
modifications.
2
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SIST EN ISO 6874:2005
INTERNATIONAL ISO
STANDARD 6874
Second edition
2005-08-15
Dentistry — Polymer-based pit and
fissure sealants
Art dentaire — Produits dentaires à base de polymères pour
comblement des puits et fissures
Reference number
ISO 6874:2005(E)
©
ISO 2005
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SIST EN ISO 6874:2005
ISO 6874:2005(E)
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ii © ISO 2005 – All rights reserved
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SIST EN ISO 6874:2005
ISO 6874:2005(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 6874 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
This second edition cancels and replaces the first edition (ISO 6874:1988), and in comparison with the first
edition the classification and the test for depth of cure have been aligned with ISO 4049:2000. It is intended to
include sealant materials within the scope of ISO 4049 at its the next revision. The requirements and tests for
uncured film thickness, sensitivity to ambient light and curing time for Type 2 sealants have been deleted from
this edition of ISO 6874.
© ISO 2005 – All rights reserved iii
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SIST EN ISO 6874:2005
ISO 6874:2005(E)
Introduction
The efficacy of pit and fissure sealants for the prevention of dental caries is widely accepted. The polymer-
based materials intended for this purpose and covered by this International Standard harden by a free-radical
polymerization reaction that is either initiated by mixing components or by external energy, e.g. visible light.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard. However, when assessing possible biological or toxicological hazards, it is
recommended to refer to ISO 10993-1 and ISO 7405.
iv © ISO 2005 – All rights reserved
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SIST EN ISO 6874:2005
INTERNATIONAL STANDARD ISO 6874:2005(E)
Dentistry — Polymer-based pit and fissure sealants
1 Scope
This International Standard specifies requirements and test methods for polymer-based materials intended for
sealing pits and fissures in teeth.
This International Standard covers both self-cured and external-energy-activated materials.
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 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
3 Classification
For the purposes of this International Standard, polymer-based pit and fissure sealants are classified,
according to the method of curing, as follows:
Class 1: Materials whose setting is effected by mixing an initiator and activator (“self-curing” materials).
Class 2: Materials whose setting is effected by the application of energy from an external source, such
as visible light (“external-energy-activated” materials).
4 Requirements
4.1 Biocompatibility
See ISO 7405 and ISO 10993-1 for guidance on biocompatibility.
4.2 Physical properties
4.2.1 Working time, Class 1 sealant
The working time for Class 1 sealants, determined in accordance with 6.4, shall not be less than 40 s.
4.2.2 Setting time, Class 1 sealant
The setting time for Class 1 sealants, determined in accordance with 6.5, shall not be greater than 5 min.
© ISO 2005 – All rights reserved 1
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SIST EN ISO 6874:2005
ISO 6874:2005(E)
4.2.3 Depth of cure, Class 2 sealant
The depth of cure for Class 2 sealants, determined in accordance with 6.6, shall not be less than 1,5 mm. If
the material is supplied in more than one shade, each shade shall comply with this requirement.
5 Sampling
The test sample shall consist of a retail package, or packages, from the same batch containing sufficient
material (a minimum of 20 g) to carry out the specified tests and repeat tests, if necessary.
6 Test methods
6.1 Inspection
Inspect visually to check that requirements specified in Clause 7 have been met.
6.2 Test conditions
Unless specified otherwise by the manufacturer, prepare and test all specimens at (23 ± 1) °C. Control the
relative humidity to ensure that it remains greater than 30 % at all times. If the material was refrigerated for
storage, allow it to attain (23 ± 1) °C before use.
For the preparation of Class 2 materials, reference should be made to the manufacturer’s instructions [see
7.3 e) and h)] that state the external energy source or sources recommended for the materials to be tested.
Care shall be taken to ensure that the source is in a satisfactory operating condition.
Reference may also be made to ISO 10650 (all parts).
6.3 Preparation of test specimens
Mix or otherwise prepare the mate
...
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