EN ISO 6876:2012
(Main)Dentistry - Root canal sealing materials (ISO 6876:2012)
Dentistry - Root canal sealing materials (ISO 6876:2012)
ISO 6876:2012 specifies requirements and test methods for root canal (endodontic) sealing materials which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It only covers sealers intended for orthograde use, i.e. a root filling placed from the coronal aspect of a tooth.
Zahnheilkunde - Wurzelkanalversiegelungswerkstoffe (ISO 6876:2012)
Diese Internationalen Norm legt Anforderungen an und Prüfverfahren für Wurzelkanalversiegelungswerkstoffe
fest, die unter Feuchtigkeitseinfluss oder ohne diesen erhärten und die für das dauerhafte Ausfüllen des
Wurzelkanals mit und ohne Hilfe von Wurzelspitzen/-stiften verwendet werden. Sie gilt nur für
Wurzelkanalversiegelungswerkstoffe, die zur orthograden Anwendung vorgesehen sind, d. h. die
Wurzelkanalfüllung wird vom koronalen Teil eines Zahnes vorgenommen.
In dieser Internationalen Norm werden keine besonderen qualitativen und quantitativen Anforderungen zum
Ausschluss biologischer Risiken gestellt. Zur Beurteilung möglicher biologischer Risiken wird jedoch
empfohlen, ISO 10993-1 und ISO 7405 heranzuziehen.
Médecine bucco-dentaire - Matériaux de scellement des canaux radiculaires (ISO 6876:2012)
L'ISO 6876:2012 spécifie les exigences et les méthodes d'essai relatives aux matériaux de scellement (endodontiques) des canaux radiculaires, dont la prise se fait avec ou sans eau et qui sont utilisés pour l'obturation définitive des canaux radiculaires avec ou sans l'aide de cônes. Elle traite uniquement des matériaux de scellement conçus pour une utilisation orthograde, c'est-à-dire l'obturation radiculaire d'une dent mise en place par voie coronaire.
Zobozdravstvo - Materiali za zapiranje zobnega kanala (ISO 6876:2012)
Ta mednarodni standard določa zahteve in preskusne metode za materiale za zapiranje zobnega kanala (endodontsko) s pomočjo vlage ali brez nje, ki se uporabljajo za trajno obturacijo zobnega kanala s pomočjo obturacijskih konic ali čepkov. Zajema le zapirala za pokončno uporabo, tj. polnjenje kanala z vrha zoba. Ta mednarodni standard ne zajema posebnih kvalitativnih in kvantitativnih preskusnih metod za dokazovanje neprisotnosti nesprejemljivih bioloških tveganj, pri čemer je za oceno takšnih bioloških tveganj priporočeno sklicevanje na standarda ISO 10993-1 in ISO 7405. Glavni spremembe so naslednje: – pregledani so bili preskusni postopki za pretok, delovni čas in raztapljanje, določena pa je bila nova mejna vrednost; – črtan je bil preskus za ugotavljanje spremembe velikosti po namestitvi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2012
1DGRPHãþD
SIST EN ISO 6876:2003
Zobozdravstvo - Materiali za zapiranje zobnega kanala (ISO 6876:2012)
Dentistry - Root canal sealing materials (ISO 6876:2012)
Zahnheilkunde - Wurzelkanalfüllpaste (ISO 6876:2012)
Médecine bucco-dentaire - Produits pour le scellement des canaux radiculaires (ISO
6876:2012)
Ta slovenski standard je istoveten z: EN ISO 6876:2012
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 6876
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2012
ICS 11.060.10 Supersedes EN ISO 6876:2002
English Version
Dentistry - Root canal sealing materials (ISO 6876:2012)
Médecine bucco-dentaire - Matériaux de scellement des Zahnheilkunde - Wurzelkanalfüllpaste (ISO 6876:2012)
canaux radiculaires (ISO 6876:2012)
This European Standard was approved by CEN on 16 June 2012.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6876:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 6876:2012) 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 January 2013, and conflicting national standards shall be withdrawn at
the latest by January 2013.
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 6876:2002.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, the United Kingdom and Turkey.
Endorsement notice
The text of ISO 6876:2012 has been approved by CEN as a EN ISO 6876:2012 without any modification.
INTERNATIONAL ISO
STANDARD 6876
Third edition
2012-06-01
Dentistry — Root canal sealing materials
Médecine bucco-dentaire — Matériaux de scellement des canaux
radiculaires
Reference number
ISO 6876:2012(E)
©
ISO 2012
ISO 6876:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 6876:2012(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 6876 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 6876:2001), which has been technically revised.
The main modifications are the following:
— the test procedures for flow, working time and solubility have been revised and a new limit value has been set;
— the test to determine dimensional change following setting has been removed.
ISO 6876:2012(E)
Introduction
Following the publication of the second edition of this International Standard (ISO 6876:2001), test houses reported
difficulties with some of the test procedures. In an attempt to improve the test procedures, a planned programme
of revision began in 2006. The following should be taken into account when using this International Standard.
— 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 are expected to 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.
— Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological
risks are not included in this International Standard but it is recommended that, for the assessment of such
biological risks, reference be made to ISO 10993-1 and ISO 7405.
iv © ISO 2012 – All rights reserved
INTERNATIONAL STANDARD ISO 6876:2012(E)
Dentistry — Root canal sealing materials
1 Scope
This International Standard specifies requirements and test methods for root canal (endodontic) sealing
materials which set with or without the assistance of moisture and are used for permanent obturation of the
root canal with or without the aid of obturating points/cones. It only covers sealers intended for orthograde use
i.e. a root filling placed from the coronal aspect of a tooth.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks
are not included in this International Standard but it is recommended that, for the assessment of such biological
risks, reference be made to ISO 10993-1 and ISO 7405.
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 3665, Photography — Intra-oral dental radiographic film and film packets — Manufacturer specifications
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 6873, Dentistry — Gypsum products
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 and the following apply.
3.1
root canal sealing material
endodontic material intended to permanently seal the root canal filling material into the cavities previously
occupied by the removed pulp
3.2
root canal filling material
endodontic material intended to permanently obturate the cavities previously occupied by the pulp
3.3
mixing time
that part of the working time required in order to obtain a satisfactory mix of the components
3.4
working time
period of time, measured from the start of mixing, during which it is possible to manipulate the root canal sealer
without any adverse effect on its properties
ISO 6876:2012(E)
3.5
setting time
period of time measured from the end of mixing until the sealer has set, according to the criteria and conditions
described in 5.4
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 free from extraneous matter when tested according to 5.1.
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 the determination of microbiological growth are not
included in this International Standard.
4.3 Physical and mechanical properties
4.3.1 Flow
When determined in accordance with 5.2, each disc shall have a diameter of not less than 17 mm.
4.3.2 Working time
For sealers that are claimed by the manufacturer to have a stated working time of up to 30 min, the diameter
of the flow test, determined in accordance with 5.2, shall be not less than 17 mm 15 s before the end of the
stated working time.
4.3.3 Setting time
For sealers that are claimed by the manufacturer to have a setting time of up to 30 min, the setting time shall
be no more than 10 % longer than that claimed by the manufacturer, when determined in accordance with 5.4.
For sealers that are claimed by the manufacturer to have a setting time of more than 30 min and up to 72 h, and
for which the manufacturer quotes a time range, the setting time measured shall be within the range stated by
the manufacturer, when determined in accordance with 5.4.
4.3.4 Film thickness
Sealers shall have a film thickness of not more than 50 µm when tested in accordance with 5.5.
4.3.5 Solubility and disintegration
The solubility of the set sealer, when determined in accordance with 5.6, shall not exceed 3,0 % by mass.
The specimen shall show no evidence of disintegration when examined visually.
4.3.6 Radio-opacity
The sealer, when tested in accordance with 5.7, shall have a radio-opacity equivalent to not less than 3 mm
of aluminium.
2 © ISO 2012 – All rights reserved
ISO 6876:2012(E)
4.4 Sampling
Use one or more retail packages from the same batch, containing sufficient sealer to carry out the specified
tests, plus an allowance for repeats, if necessary.
4.5 Test conditions
Unless otherwise stated by the manufacturer, carry out all tests at (23 ± 2) °C and at (50 ± 5) % RH. Condition
all components at this temperature and relative humidity for at least 24 h prior to testing.
4.6 Preparation of material for testing
Manipulate all the components of the sealer in accordance with the manufacturer’s instructions for use.
5 Test methods
5.1 Extraneous matter
Examine under normal visual acuity.
5.2 Flow
5.2.1 Apparatus
5.2.1.1 Two glass plates, at least 40 mm × 40 mm and approximately 5 mm thick, and with a mass of
approximately 20 g.
5.2.1.2 A weight with a mass of approximately 100 g.
5.2.1.3 Graduated syringe, designed to deliver (0,05 ± 0,005) ml of mixed sealer.
5.2.2 Procedure
Place (0,05 ± 0,005) ml of sealer on the centre of one of the glass plates using the graduated syringe.
NOTE An alternative method is to use the mass of the sample, having first determined the density, and use the formula:
m = V × d
where
m is mass;
d is density;
V is volume.
At (180 ± 5) s after the commencement of mixing, place the second glass plate centrally on top of the sealer
and an additional mass on the plate to total (120 ± 2) g. Ten minutes after the commencement of mixing,
remove the weight and measure the maximum and minimum diameters of the compressed disc of sealer. If the
diameters are within 1 mm of each other, record the mean of the two diameters. If the two dia
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.