SIST EN ISO 6876:2003
(Main)Dental root canal sealing materials (ISO 6876:2001)
Dental root canal sealing materials (ISO 6876:2001)
Migrated from Progress Sheet (TC Comment) (2000-07-10): draft BP: UAP on ISO 6876 when published (TA/990326)
Zahnärztliche Wurzelkanalfüllungswerkstoffe (ISO 6876:2001)
In dieser Internationalen Norm sind Anforderungen und Prüfverfahren für Wurzelkanalfüllungswerkstoffe festgelegt, die mit und ohne Mitwirkung von Feuchtigkeit aushärten und für den dauerhaften Verschluss des Wurzelkanals mit oder ohne Hilfe von Wurzel(kanal)spitzen verwendet werden. Sie gilt nur für Füllungswerkstoffe die zur orthogonalen Anwendung vorgesehen sind, d. h. die Wurzelkanalfüllung wird durch die Zahnkrone gelegt.
Produits dentaires pour le scellement des canaux radiculaires (ISO 6876:2001)
Materiali za zapiranje zobnega kanala (ISO 6876:2001)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 6876:2003
01-marec-2003
1DGRPHãþD
SIST EN 26876:2000
SIST EN 26876:2000/AC1:2000
Materiali za zapiranje zobnega kanala (ISO 6876:2001)
Dental root canal sealing materials (ISO 6876:2001)
Zahnärztliche Wurzelkanalfüllungswerkstoffe (ISO 6876:2001)
Produits dentaires pour le scellement des canaux radiculaires (ISO 6876:2001)
Ta slovenski standard je istoveten z: EN ISO 6876:2002
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 6876:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 6876:2003
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SIST EN ISO 6876:2003
EUROPEAN STANDARD
EN ISO 6876
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2002
ICS 11.060.10 Supersedes EN 26876:1990
English version
Dental root canal sealing materials (ISO 6876:2001)
Produits dentaires pour le scellement des canaux Zahnärztliche Wurzelkanalfüllungswerkstoffe (ISO
radiculaires (ISO 6876:2001) 6876:2001)
This European Standard was approved by CEN on 23 September 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, 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
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6876:2002 E
worldwide for CEN national Members.
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SIST EN ISO 6876:2003
EN ISO 6876:2002 (E)
CORRECTED 2003-01-08
Foreword
The text of ISO 6876:2001 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
6876:2002 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 May 2003, and conflicting national standards
shall be withdrawn at the latest by May 2003.
This document supersedes EN 26876:1990.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 6876:2001 has been approved by CEN as EN ISO 6876:2002 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2
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SIST EN ISO 6876:2003
EN ISO 6876:2002 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 3696 1987 Water for analytical laboratory use – EN ISO 3696 1995
Specification and test methods
3
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SIST EN ISO 6876:2003
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SIST EN ISO 6876:2003
INTERNATIONAL ISO
STANDARD 6876
Second edition
2001-08-15
Dental root canal sealing materials
Produits dentaires pour le scellement des canaux radiculaires
Reference number
ISO 6876:2001(E)
© ISO 2001
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SIST EN ISO 6876:2003
ISO 6876:2001(E)
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© ISO 2001
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, elec-
tronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's mem-
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©
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SIST EN ISO 6876:2003
ISO 6876:2001(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 1
4.1 Components . 1
4.2 Microbiological hazard . 2
4.3 Physical and mechanical properties . 2
5 Sampling . 3
6 Test conditions . 3
7 Test methods . 3
7.1 Extraneous matter . 3
7.2 Flow . 3
7.3 Working time . 4
7.4 Setting time . 4
7.5 Film thickness . 5
7.6 Dimensional change following setting . 5
7.7 Solubility . 6
7.8 Radiopacity . 7
8 Packaging, marking and information to be supplied by manufacturer . 8
8.1 General . 8
8.2 Packaging . 8
8.3 Marking . 8
8.4 Manufacturer's instructions and information for the purchaser . 9
Bibliography. 10
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SIST EN ISO 6876:2003
ISO 6876:2001(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 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 6876 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 6876:1986), which has been technically revised.
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SIST EN ISO 6876:2003
ISO 6876:2001(E)
Introduction
This International Standard was first published in 1986 (ISO 6876:1986). There were significant differences between
ISO 6876 and the United States specification ANSI/ADA Specification No 57 (1983). In addition test houses had
reported difficulties with some of the test procedures in the International Standard. In an attempt to harmonize the
ISO and ANSI/ADA Standards and improve the test procedures, a planned programme of revision was commenced
in 1991. The changes in this second edition are as follows:
The classification has been removed.
Non-setting materials are no longer covered by this International Standard.
The test procedures for flow, working time and setting time have been altered.
A new test to determine dimensional change following setting has been added.
For dental root canal sealers which require moisture to facilitate setting, a new test procedure to simulate the setting
mode of the sealers in the root canal system has been included.
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SIST EN ISO 6876:2003
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SIST EN ISO 6876:2003
INTERNATIONAL STANDARD ISO 6876:2001(E)
Dental root canal sealing materials
1 Scope
This International Standard specifies requirements and test methods for root canal sealing materials which set with
and without the assistance of moisture and are used for permanent obturation of the root canal, with or without the
aid of obturating points. It is applicable only to sealers intended for orthograde use, i.e. a root filling placed from the
coronal aspect of a tooth.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 3665:1996, Photography — Intra-oral dental radiographic film — Specification.
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods.
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
mixing time
that part of the working time specified or required in order to obtain a satisfactory mix of the components
3.2
working time
period of time, measured from the start of mixing, during which it is possible to manipulate the dental sealer without
an adverse effect on its properties
3.3
setting time
period of time measured from the end of mixing until the sealer has set according to the criteria and conditions
described in 7.4
NOTE For the purposes of this International Standard, the setting time is determined from the end of mixing because of the wide
variation in mixing times.
4 Requirements
4.1 Components
The components of the sealer shall be visually free from extraneous matter when tested according to 7.1.
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SIST EN ISO 6876:2003
ISO 6876:2001(E)
The components shall, when used in accordance with the manufacturer's instructions, form a sealer which complies
with the requirements of this International Standard.
4.2 Microbiological hazard
Specific qualitative and quantitative requirements for freedom from biological hazards 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.
Verification for a claim of sterility is the responsibility of the manufacturer. This International Standard does not
specify requirements or test methods for sterility and it is recommended that reference be made to any national
requirements that may exist. When no national requirements exist, reference should be made to the United States,
European or Japanese Pharmacopoeia.
If a therapeutic effect is claimed, the purity and sterility of the constituents shall comply with the relevant
pharmacopoeia applicable in the country in which the sealer is marketed, or with such national regulations as are
applicable to purity and sterility of pharmaceutical products.
4.3 Physical and mechanical properties
4.3.1 Flow
When determined in accordance with 7.2, each disc shall have a diameter not less than 20 mm.
4.3.2 Working time
The minimum working time of a sealer, when determined by the method described in 7.3, shall be not less than 90 %
of the working time stated by the manufacturer.
This test applies only to sealers having a working time claimed by the manufacturer to be less than 30 min.
4.3.3 Setting time
For sealers having a setting time of less than 30 min, the setting time of a sealer, when determined by the method
described in 7.4, shall be no greater than 110 % of that stated by the manufacturer.
For sealers having a setting time greater than 30 min, and up to 72 h, for which the manufacturer quotes a time
range, the setting time measured shall be within the range stated by the manufacturer.
4.3.4 Film thickness
Sealers shall have a film thickness of not more than 50m when tested in accordance with 7.5.
4.3.5 Dimensional change following setting
The mean dimensional change in length of the sealer, measured in accordance with the method set out in 7.6, shall
not exceed 1,0 % in shrinkage or 0,1
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