SIST EN ISO 6877:2021
(Main)Dentistry - Endodontic obturating materials (ISO 6877:2021)
Dentistry - Endodontic obturating materials (ISO 6877:2021)
This document establishes the specifications for the dimensions of various endodontic obturating
materials including preformed metal, preformed polymeric-coated metal, polymeric points,
thermoplastic obturating material or combinations of the above, suitable for use in the obturation of
the root canal system. This document also specifies numerical systems and a colour-coding system for
designating the sizes of preformed endodontic obturating points.
Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers
the physical attributes expected of such products as supplied.
Sterility is not included in this document, and any claim that the product is sterile is the responsibility
of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for
use.
This document does not apply to instruments or apparatus used in conjunction with thermoplastic
obturating materials (obturating material that deform with heat). This document is not applicable to
materials for support of a coronal restoration.
Zahnheilkunde - Endodontische Obturationswerkstoffe (ISO 6877:2021)
Dieses Dokument legt Anforderungen an die Maße und an die Zusammensetzung von verschiedenen endodontischen Werkstoffen, einschließlich vorgefertigten Stiften aus Metall, kunststoffbeschichtetem Metall- oder Kunststoffstiften, thermoplastischem endodontischem Obturationswerkstoff oder Kombinationen davon fest, die zur Obturation eines Wurzelkanalsystems geeignet sind. Dieses Dokument beschreibt auch ein Nummernsystem und ein Farbkennzeichnungssystem zur Größenbezeichnung.
Dieses Dokument umfasst keine Werkstoffe für Wurzelstifte, die für Aufbauten verwendet werden. Dentale endodontische Füllstifte sind in steriler oder nicht steriler Form im Handel erhältlich. Diese Internationale Norm beschreibt die physikalischen Eigenschaften, die von Produkten dieser Art im Lieferzustand erwartet werden. Anforderungen an die Sterilität sind nicht enthalten, und jeder Anspruch auf Sterilität des Produktes
- fällt in den Verantwortungsbereich des Herstellers (siehe Tabelle 3). Artikel 7 legt die Anforderungen an
- die Verpackung und Etikettierung einschließlich der Gebrauchsanweisung fest.
Diese Internationale Norm gilt nicht für Instrumente oder Ausrüstung, die in Verbindung mit thermoplastischen Obturationswerkstoffen (Obturationswerkstoff, der sich bei Hitze verformt), verwendet werden.
Médecine bucco-dentaire - Matériaux d’obturation endodontique(ISO 6877:2021)
Le présent document établit les spécifications pour les dimensions de divers matériaux d’obturation endodontique incluant les cônes métalliques préformés, les cônes métalliques préformés revêtus de polymère, les cônes à base de polymères, les matériaux d’obturation thermoplastiques ou les combinaisons de ceux-ci, qui sont appropriés pour être utilisés dans le cadre de l’obturation du système de canaux radiculaires. Le présent document spécifie également des systèmes numériques et un système de code de couleur pour la désignation des tailles de cônes d’obturation endodontique préformés.
Les cônes d'obturation endodontique sont commercialisés stérilisés ou non stérilisés. Le présent document couvre les caractéristiques physiques attendues de ces produits tels qu'ils sont fournis.
La stérilité n’est pas abordée dans le présent document et toute revendication indiquant que le produit est stérile est sous la responsabilité du fabricant (voir Tableau 3). L’Article 7 spécifie l’étiquetage, y compris les instructions d’utilisation.
Le présent document ne s’applique pas aux instruments ou à l’appareillage utilisés en association avec les matériaux d'obturation thermoplastiques (matériaux d’obturation qui se déforment sous l’effet de la chaleur). Le présent document n’est pas applicable aux matériaux utilisés pour l’ancrage d’une restauration coronaire.
Zobozdravstvo - Endodontski materiali za polnitev koreninskih kanalov (obturacijo) (ISO 6877:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 6877:2021
01-december-2021
Nadomešča:
SIST EN ISO 6877:2006
Zobozdravstvo - Endodontski materiali za polnitev koreninskih kanalov
(obturacijo) (ISO 6877:2021)
Dentistry - Endodontic obturating materials (ISO 6877:2021)
Zahnheilkunde - Endodontische Obturationswerkstoffe (ISO 6877:2021)
Médecine bucco-dentaire - Matériaux d’obturation endodontique(ISO 6877:2021)
Ta slovenski standard je istoveten z: EN ISO 6877:2021
ICS:
11.060.10 Zobotehnični materiali Dental materials
SIST EN ISO 6877:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 6877:2021
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SIST EN ISO 6877:2021
EN ISO 6877
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2021
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 6877:2006
English Version
Dentistry - Endodontic obturating materials (ISO
6877:2021)
Médecine bucco-dentaire - Matériaux d'obturation Zahnheilkunde - Endodontische Obturationswerkstoffe
endodontique(ISO 6877:2021) (ISO 6877:2021)
This European Standard was approved by CEN on 7 August 2021.
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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6877:2021 E
worldwide for CEN national Members.
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SIST EN ISO 6877:2021
EN ISO 6877:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 6877:2021
EN ISO 6877:2021 (E)
European foreword
This document (EN ISO 6877:2021) 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 March 2022, and conflicting national standards shall
be withdrawn at the latest by March 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 6877:2006.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 6877:2021 has been approved by CEN as EN ISO 6877:2021 without any modification.
3
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SIST EN ISO 6877:2021
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SIST EN ISO 6877:2021
INTERNATIONAL ISO
STANDARD 6877
Third edition
2021-09
Dentistry — Endodontic obturating
materials
Médecine bucco-dentaire — Matériaux d’obturation endodontique
Reference number
ISO 6877:2021(E)
©
ISO 2021
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SIST EN ISO 6877:2021
ISO 6877:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 6877:2021
ISO 6877:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 Appearance . 3
4.2 Length . 3
4.3 Size designation and taper . 3
4.3.1 General. 3
4.3.2 Standard points . 3
4.3.3 Greater taper points . 5
4.3.4 Variable taper points . 5
4.3.5 Auxiliary points . 5
4.3.6 Carrier-based obturating material . 5
4.4 Physical integrity . 6
4.5 Radiopacity . 6
4.6 Colour-coding . 6
5 Procurement of samples. 7
6 Measurement and test methods . 7
6.1 Test conditions . 7
6.2 Visual examination . 7
6.2.1 General. 7
6.2.2 Labels . 7
6.2.3 Instructions for use. 8
6.3 Length . 8
6.3.1 Apparatus . 8
6.3.2 Method . 8
6.4 Size designation . 8
6.4.1 Apparatus . 8
6.4.2 Method . 8
6.4.3 Taper. 9
6.5 Physical integrity . 9
6.5.1 General. 9
6.5.2 Apparatus . 9
6.5.3 Method . 9
6.5.4 Interpretation of the results .10
6.6 Radiopacity for polymeric points and carrier-based obturating devices .11
6.6.1 Apparatus .11
6.6.2 Procedure .11
6.6.3 Interpretation of the results .11
6.7 Melt mass flow rate .11
7 Packaging, marking and instructions and information to be supplied by the
manufacturer .12
7.1 Packaging .12
7.2 Labelling .12
7.3 Declaration of components .13
Annex A (normative) .14
Melt mass-flow rate test
Bibliography .17
© ISO 2021 – All rights reserved iii
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SIST EN ISO 6877:2021
ISO 6877:2021(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling
and Restorative Materials, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 6877:2006), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— use of “endodontic” rather than “root canal” for the terminology;
— inclusion of points having a non-uniform taper;
— inclusion of thermoplastic materials not in the form of a point;
— standardization to the use of D, d and d for measurements of endodontic points at the projection
3 16
of the tip, 3 mm or 16 mm from the tip of a point;
— harmonization of D, d and d with the ISO 3630 series;
3 16
— reconsidering tests methods;
— addition of ISO 13116 for test method for determining radiopacity of material as a normative
reference;
— augmenting the packaging requirements for providing information;
— addition of an annex for measuring the melt-flow rate of thermoplastic materials that are not
supplied in point form.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
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SIST EN ISO 6877:2021
ISO 6877:2021(E)
Introduction
The following information should be taken into account when using this document: specific qualitative
and quantitative test methods for demonstrating freedom from unacceptable biological risks are not
included in this document but it is recommended that, for the assessment of such biological risks,
reference be made to ISO 7405 and ISO 10993-1. No performance limits are provided in this document
for melt mass flow rate, but they might be added in the future.
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SIST EN ISO 6877:2021
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SIST EN ISO 6877:2021
INTERNATIONAL STANDARD ISO 6877:2021(E)
Dentistry — Endodontic obturating materials
1 Scope
This document establishes the specifications for the dimensions of various endodontic obturating
materials including preformed metal, preformed polymeric-coated metal, polymeric points,
thermoplastic obturating material or combinations of the above, suitable for use in the obturation of
the root canal system. This document also specifies numerical systems and a colour-coding system for
designating the sizes of preformed endodontic obturating points.
Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers
the physical attributes expected of such products as supplied.
Sterility is not included in this document, and any claim that the product is sterile is the responsibility
of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for
use.
This document does not apply to instruments or apparatus used in conjunction with thermoplastic
obturating materials (obturating material that deform with heat). This document is not applicable to
materials for support of a coronal restoration.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 3630-1, Dentistry — Endodontic instruments — Part 1: General requirements
ISO 13116, Dentistry — Test method for determining radio-opacity of materials
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer —
Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 3630-1 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org
3.1
endodontic obturating material
substance intended as a definitive product to fill a prepared root canal system, usually a combination of
points (3.2) and endodontic sealer (3.15)
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SIST EN ISO 6877:2021
ISO 6877:2021(E)
3.2
point
preformed metal, preformed polymeric-coated metal, and polymeric cones for use in the obturation of
a root canal system
Note 1 to entry: For the purposes of this document, the term “endodontic obturating point (cone)” is abbreviated
as “point”.
3.3
size designation
numerical indication, “000”, of the projected tip diameter, measured in hundredths of a millimetre
3.4
taper
percentage increase in diameter along the length of the point (3.2)
EXAMPLE 02 taper represents a 2 % increase in diameter along the length of the point.
3.5
standard point
point (3.2) having a uniform 02 taper over the first 16 mm
3.6
greater taper point
point (3.2) having a uniform taper greater than 02 over the first 16 mm
3.7
variable taper point
point (3.2) which has a taper that varies over the first 16 mm
3.8
auxiliary point
point (3.2) excepting standard point (3.5), greater taper point (3.6) and variable taper point (3.7)
3.9
carrier-based obturating device
point (3.2) designed to obturate a root canal with thermoplastic polymeric material coated on a core
material, usually in the shape of a point (3.2)
Note 1 to entry: The core material remains in the canal or may be removed after carrying the thermoplastic
material.
3.10
injection material
substance supplied in non-conical form, such as pellets for injection after being warmed to a
thermoplastic state
3.11
injection system
instrument designed to obturate a root canal with thermoplasticized injection material (3.9) using an
injection equipment or device
3.12
melt mass-flow rate
MFR
measure of flow through a capillary of a thermoplastic polymer at a particular temperature, measured
in grams per unit time at a given force
3.13
unit pack
smallest pack of points distributed, containing one or more sizes of points (3.2)
2 © ISO 2021 – All rights reserved
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SIST EN ISO 6877:2021
ISO 6877:2021(E)
3.14
radiopacity
property of obstructing the passage of radiant energy, such as x-rays, through the representative areas
appearing grey or white on the exposed film or sensor image
3.15
endodontic sealer
material intended to permanently seal the root canal dentine from the periapical tissue usually in
combination with a solid or semi-solid core material [endodontic obturating material (3.1)], to fill voids
and to seal root canals during orthograde obturation
4 Requirements
4.1 Appearance
Throughout the tapered length, the point shall be smooth and uniform in appearance, free from
extraneous matter. Test according to 6.2.
4.2 Length
Unless otherwise stated by the manufacturer, the overall length shall be not less than 28 mm. Test
according to 6.3.
4.3 Size designation and taper
4.3.1 General
The designation shall be in the form of a five-digit numerical set, having two parts: 000 XX, where 000
corresponds to the size designation and XX corresponds to the two significant figures of the taper per
cent. For example, a 2 % taper is designated as 02.
The diameter tolerance of points at d (see Figure 1) shall be:
16
— ±0,02 mm for metallic points (cones),
— ±0,05 mm for polymeric points or carrier-based obturating devices of sizes 008 to 025,
— ±0,07 mm for polymeric points of carrier-based obturating devices of sizes 030 to 140.
The tolerances of 0,05 and 0,07 are not applicable to D.
4.3.2 Standard points
a) The taper of the points shall be uniform for a minimum of 16 mm from the tip (see Figure 1),
increasing at 2 % (02) along their length.
b) The size designation of standard polymer points or carrier-based obturating devices shall be in
accordance with the numbering system shown in Table 1.
Test according to 6.4.2, and calculate the taper as described in 6.4.3.
© ISO 2021 – All rights reserved 3
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SIST EN ISO 6877:2021
ISO 6877:2021(E)
Key
D diameter of the projection of the point at the tip
d diameter at 3 mm from tip
3
d diameter at 16 mm from tip
16
l total length of the instrument
tot
NOTE 1 The diameters D, d and d are expressed in millimetres
3 16
NOTE 2 Table 1 gives values of D, d and d for each size of standard points, not carrier-based obturation
3 16
devices.
NOTE 3 The exact shape of the tip is left to the option of the manufacturer.
Figure 1 — Diagrammatic representation of a point
Table 1 — Size designation for standard points
Dimensions in millimetres
Size designation
D d d
3 16
008 0,08 0,14 0,40
010 0,10 0,16 0,42
015 0,15 0,21 0,47
020 0,20 0,26 0,52
025 0,25 0,31 0,57
030 0,30 0,36 0,62
035 0,35 0,41 0,67
040 0,40 0,46 0,72
045 0,45 0,51 0,77
050 0,50 0,56 0,82
055 0,55 0,61 0,87
060 0,60 0,66 0,92
070 0,70 0,76 1,02
080 0,80 0,86 1,12
090 0,90 0,96 1,22
100 1,00 1,06 1,32
NOTE The tolerances of 0,05 and 0,07 from 4.3.1 are not
applicable to D.
4 © ISO 2021 – All rights reserved
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SIST EN ISO 6877:2021
ISO 6877:2021(E)
Table 1 (continued)
Size designation
D d d
3 16
110 1,10 1,16 1,42
120 1,20 1,26 1,52
130 1,30 1,36 1,62
140 1,40 1,46 1,72
NOTE The tolerances of 0,05 and 0,07 from 4.3.1 are not
applicable to D.
4.3.3 Greater taper points
a) The size designation of greater taper polymer points or carrier-based obturating devices shall be in
accordance with the numbering system shown in Table 1.
b) The taper of the points shall be uniform for a minimum of 16 mm from the tip (Figure 1), increasing
along their length at the taper given by the manufacturer.
Test according to 6.4.2, and calculate the taper as described in 6.4.3.
4.3.4 Variable taper points
The tip diameter and the taper type of the variable taper points shall be designated as variable by the
manufacturer (Table 2).
The tolerances of ±0,05 and ±0,07 are not applicable to D.
The colour of variable taper points should be that colour corresponding to the tip size in Table 2.
Test according to 6.4.2.
4.3.5 Auxiliary points
The taper of the auxiliary points is from 02 to 09 (2 % to 9 %).
The tip size of the auxiliary points is left to the discretion of the manufacturer.
The colour of auxiliary points should be that colour corresponding to the tip size in Table 2.
4.3.6 Carrier-based obturating material
Figure 2 shows the features of a carrier-based obturating device. If standard, these points shall conform
to the dimensional requirements of Table 1.
If variable, the taper of the points is variable over the first 16 mm. The tip diameter and the taper type
of the points shall be designated as variable by the manufacturer (see Table 3).
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SIST EN ISO 6877:2021
ISO 6877:2021(E)
Key
D diameter of the projection of the core at the tip
d diameter of the core at 3 mm from the tip
3
d diameter of the core at 16 mm from tip
16
l length of the operative part, measured from the tip of the core
op
1 coating of thermoplastic material (polymeric material)
2 rigid or semi-rigid core
3 calibration marks
4 flexible stop, if provided
5 handle
NOTE 1 The diameters D, d and d are expressed in hundredths of a millimetre.
3 16
NOTE 2 The core is shown at the top and the coated carrier is shown at the bottom.
Figure 2 — Diagrammatic representation of carrier-based obturating devices
4.4 Physical integrity
Samples tested shall not show any sign of fracture (separation), fissures or cracks when tested according
to 6.5.
4.5 Radiopacity
The material from which polymeric points are made shall have a radiopacity equivalent to at least 3 mm
aluminium.
Test according 6.6 and ISO 13116 using 1 mm thick samples.
4.6 Colour-coding
The use of colour-coding on the packaging or the individual p
...
SLOVENSKI STANDARD
oSIST prEN ISO 6877:2020
01-junij-2020
Zobozdravstvo - Endodontski materiali za polnitev koreninskih kanalov
(obturacijo) (ISO/DIS 6877:2020)
Dentistry - Endodontic obturating materials (ISO/DIS 6877:2020)
Zahnheilkunde - Endodontische Obturationsmaterialien (ISO/DIS 6877:2020)
Art dentaire - Cônes d'obturation dentaires pour canaux radiculaires
Ta slovenski standard je istoveten z: prEN ISO 6877
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 6877:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 6877:2020
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oSIST prEN ISO 6877:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 6877
ISO/TC 106/SC 1 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2020-04-16 2020-07-09
Dentistry — Endodontic obturating materials
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 6877:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 6877:2020
ISO/DIS 6877:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 6877:2020
ISO/DIS 6877:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normatives references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 Appearance . 3
4.2 Length . 3
4.3 Size designation and taper . 4
4.3.1 General. 4
4.3.2 Standard points . 4
4.3.3 Greater taper points . 4
4.3.4 Variable taper points . 5
4.3.5 Auxiliary obturating material . 5
4.4 Physical integrity . 6
4.5 Radiopacity . 6
4.6 Color-coding . 6
5 Procurement of samples. 7
6 Test methods . 7
6.1 Test conditions . 7
6.2 Visual examination . 7
6.2.1 Labels . 7
6.2.2 Instructions for Use . 8
6.3 Length . 8
6.3.1 Equipment . 8
6.3.2 Method . 8
6.4 Size designation . 8
6.4.1 Equipment . 8
6.4.2 Method . 8
6.4.3 Taper. 9
6.5 Physical integrity . 9
6.5.1 Equipment . 9
6.5.2 Method . 9
6.5.3 Interpretation of the results . 9
6.6 Radiopacity for polymeric points and carrier-based obturating devices .10
6.6.1 Equipment .10
6.6.2 Method .11
6.6.3 Interpretation of the results .11
7 Packaging, marking and instructions and information to be supplied by the
manufacturer .11
7.1 Packaging .11
7.2 Labeling .11
7.3 Declaration of components .12
Annex A (informative) .14
Melt mass-flow rate test
Bibliography .17
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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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document 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 6877:2006), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Use of “endodontic” rather than “root canal” for the terminology;
— Inclusion of points have non-uniform taper;
— Inclusion of thermoplastic materials not in the form of a point;
— Standardization to the use of d , d and d for measurements of endodontic points at the projection
0 3 16
of the tip, 3 mm or 16 mm from the tip of a point;
— Addition of ISO 13116 for digital radiopacity as a normative reference;
— Change in the radiopacity sample thickness to 1 mm from 2 mm with concomitant reduction of the
radiopacity requirement from 6 mm to 3 mm of equivalent Al;
— Augmenting the packaging requirements for providing information;
— Addition of an annex for measuring the melt-flow rate of thermoplastic materials that are not
supplied in point form. No performance limits are provided in this document but they may beadded
in the future.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
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Introduction
The following should be taken into account when using this International Standard:
— 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 7405 and ISO 10993-1.
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oSIST prEN ISO 6877:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 6877:2020(E)
Dentistry — Endodontic obturating materials
1 Scope
In this document are the specifications for the dimensional and compositional requirements for various
endodontic obturating materials including preformed metal, preformed polymeric-coated metal,
polymeric points, thermoplastic obturating material or combinations of the above suitable for use in
the obturation of the root canal system. This document also specifies numerical systems and a color-
coding system for designating the sizes.
This document does not include materials for support of a coronal restoration. Dental endodontic
obturating points are marketed sterilized or non-sterilized. This
International Standard covers the physical attributes expected of such products as supplied.
Requirements for sterility are not included, and any claim that the product is sterile is the
— responsibility of the manufacturer (see Table 3). Article 7 specifies the requirements for
— packaging and labelling, including the instructions for use.
This International Standard does not apply to instruments or equipment used in conjunction with
thermoplastic obturating materials (obturating material that deform with heat).
2 Normatives references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ASTM D1238, Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ISO 1942, Dentistry —Vocabulary
ISO 1133-1, Plastics — Determination of the melt mass-flow rate (MFR) and melt volume-flow rate (MVR)
of thermoplastics — Part 1: Standard method
ISO 1133-2, Plastics — Determination of the melt mass-flow rate (MFR) and melt volume-flow rate (MVR)
of thermoplastics — Part 2: Method for materials sensitive to time-temperature history and/or moisture
ISO 3630-1, Dentistry — Endodontic instruments — Part 1: General requirements
ISO 3665, Photography — Intra-oral dental radiographic film and film packets — Manufacturer
specifications
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137, Sterilization of health care products — Radiation
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ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11737-2, Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
ISO 11138-1, Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 11138-2, Sterilization of health care products — Biological indicators — Part 2: Biological indicators
for ethylene oxide sterilization processes
ISO 11138-3, Sterilization of health care products — Biological indicators — Part 3: Biological indicators
for moist heat sterilization processes
ISO 11139, Sterilization of health care products — Vocabulary of terms used in sterilization and related
equipment and process standards
ISO 13116, Dentistry — Test method for determining radio-opacity of materials
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical
devices utilizing animal tissues and their derivatives — Requirements for characterization, development,
validation and routine control of a sterilization process for medical devices
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information
to be supplied — Part 2: Symbol development, selection and validation
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 3630-1 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http: //www .electropedia .org
3.1
endodontic obturating material
substance intended to permanently obturate the cavities previously occupied by the pulp, and may be
augmented by a sealing material
3.2
point
preformed metal, preformed polymeric-coated metal, and polymeric cones for use in the obturation of
a root canal
Note 1 to entry: For the purposes of this International Standard the term “endodontic obturating point (cone)” is
abbreviated as “point”.
3.3
size designation
numerical indication, “000”, of the projected tip diameter, measured in hundredths of a millimetre
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3.4
taper
percentage increase in diameter along the length of the point
EXAMPLE 02 taper represents a 2 % increase in diameter along the length of the point.
3.5
standard point
point having a uniform 02 taper
3.6
greater taper point
point having a taper greater than 02, which may be uniform or variable over the length
3.7
carrier-based obturating device
point designed to obturate a root canal with thermoplastic polymeric material coated on a core material
Note 1 to entry: The core material remains in the canal or removed after carrying the thermoplastic material.
3.8
injection material
substance supplied in non-conical form, such as pellets, for injection after being warmed to a
thermoplastic state
3.9
injection system
instrument designed to obturate a root canal with thermoplasticized injection material using an
injection apparatus or device
3.10
auxiliary obturating material
substance supplied in non-conical form, such as pellets, for injection after being heated to a
thermoplastic stateClause
3.11
melt mass-flow rate (MFR)
a measure of flow through a capillary of a thermoplastic polymer at a particular temperature, measured
in grams per unit time at a given force
3.12
unit pack
smallest pack of points distributed, containing one or more sizes of points
3.13
radiopacity
the property of obstructing the passage of radiant energy, such as x-rays, the representative areas
appearing light or white on the exposed x-ray sensor
4 Requirements
4.1 Appearance
Throughout the tapered length, the point shall be smooth and uniform in appearance. Test according to
6.2.
4.2 Length
Unless otherwise stated by the manufacturer, the overall length shall be not less than (28 ± 1) mm. Test
according to 6.3.
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4.3 Size designation and taper
4.3.1 General
The designation shall be in the form of a five-digit numerical set, having two parts: 000 XX, where 000
corresponds to the size designation and XX corresponds to the two significant figures of the taper.
The diameter tolerance of points at d16 (Fig 1) shall be:
— 0.02 mm for metallic points (cones),
— 0.05 mm for polymeric points or carrier-based obturating devices of sizes 8 to 25,
— 0.07 mm for polymeric points of carrier-based obturating devices of sizes 30 to 140.
4.3.2 Standard points
a) The size designation of polymer points or carrier-based obturating devices shall be in accordance
with the numbering system shown in Table 1.
b) The taper of the points shall be uniform for a minimum of 16 mm from the tip (Figure 1), increasing
at 2 % (02) along their length. The calculated taper shall be within ± 10 % of the stated taper.
Test according to 6.4.2, and calculate the taper as described in 6.4.3.
4.3.3 Greater taper points
The taper of the points shall be larger than 02. The tip diameter and the taper of the points shall be
designated by the manufacturer (Table 3). If uniform, the calculated taper shall be within ± 10% of the
stated taper.
Test according to 6.4.2 and calculate the taper as shown in 6.4.3.
Table 1 — Size designation for standard points
Dimensions in millimetres
Size designation Diameter Diameter Diameter
d d d
0 3 16
010 0.10 0.16 0.42
015 0.15 0.21 0.47
020 0.20 0.26 0.52
025 0.25 0.31 0.57
030 0.30 0.36 0.62
035 0.35 0.41 0.67
040 0.40 0.46 0.72
045 0.45 0.51 0.77
050 0.50 0.56 0.82
055 0.55 0.61 0.87
060 0.60 0.66 0.92
070 0.70 0.76 0.102
080 0.80 0.86 0.112
090 0.90 0.96 0.122
100 1.00 1.06 1.32
110 1.10 1.16 1.42
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Table 1 (continued)
Size designation Diameter Diameter Diameter
d d d
0 3 16
120 1.20 1.26 1.52
130 1.30 1.36 1.62
140 1.40 1.46 1.72
4.3.4 Variable taper points
The taper of the points is variable over the first 16 mm. The tip diameter and the taper type of the
points shall be designated as variable by the manufacturer (Table 3).
Test according to 6.4.2.
4.3.5 Auxiliary obturating material
The taper of the auxiliary points is from 2 % to 9%.
The tip size of the auxiliary points is let to the discretion of the manufacturer.
Key
d diameter of tip (projected diameter)
0
d diameter at 3 mm from tip d = diameter at 16 mm from tip
3 16
l overall length
1 optional flattened end a tip
a
tip
NOTE 1 The diameters d , d and d are expressed in hundredths of a millimetre
0 3 16
NOTE 2 Table 1 gives values of d , d and d for each size.
0 3 16
Figure 1 — Diagrammatic representation of a point
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oSIST prEN ISO 6877:2020
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Key
d diameter at the tip
o
d diameter at 3 mm from the tip
3
d diameter at 16 mm from tip
16
l operative length
1 coating of thermoplastic material (polymeric material)
2 rigid or semi-rigid core
3 length marks
4 flexible stop
5 handle
NOTE 1 The diameters d , d and d are expressed in hundredths of a millimetre.
0 3 16
NOTE 2 Table 1 gives values of d , d and d for each size.
0 3 16
Figure 2 — Diagrammatic representation of carrier-based obturating devices. The core is
shown at the top and the coated carrier is shown at the bottom.
4.4 Physical integrity
Samples tested shall not show any sign of fracture (separation), fissures, cracks when tested
according to 6.5.
4.5 Radiopacity
The material from which polymeric points are made shall have a radio-opacity equivalent to at least
3 mm aluminium.
Test according 6.6 and ISO 13116 using 1 mm thick samples.
4.6 Color-coding
The use of color-coding on the packaging or the individual points to indicate the nominal size
designation is optional; if used, the colours shall conform to Table 2.
No color-code system has been designated for taper.
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Table 2 — Color-code for size designation
Size designation Colour Abbreviation
010 purple pur
015 white wht
020 yellow yel
025 red red
030 blue blu
035 green grn
040 black blk
045 white wht
050 yellow yel
055 red red
060 blue blu
070 green grn
080 black blk
090 white wht
100 yellow yel
110 red red
120 blue blu
130 green grn
140 black blk
5 Procurement of samples
Procure all samples for testing for compliance with this International Standard on the open market.
Procure at least 30 g of auxiliary obturating material for testing.
6 Test methods
6.1 Test conditions
Conduct all tests at (23 ± 2) °C and a relative humidity of (50 ± 20) %. Condition the points at this
temperature and humidity for 24 h prior to testing.
6.2 Visual examination
Choose ten points at random. Visually examine, without magnification, the characteristics of the points
as specified in clause 4.1.
NOTE The observer is to be of normal visual acuity.
6.2.1 Labels
References, name of the manufacturer, graphical symbols, lot number and product designation shall be
displayed.
When the package is sterile, marked with the symbol for "Sterile" in accordance with ISO 15223-1.
Graphical symbols shall comply with ISO 15223-1.
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6.2.2 Instructions for Use
The following information shall be provided:
— general information (name of the manufacturer, product designation),
— indications for use,
— contraindications,
— warnings,
— precautions,
— adverse reactions,
— step-by-step instructions.
6.3 Length
6.3.1 Equipment
A visual measurement equipment shall be used for measuring the length with a minimum accuracy
of 0,1 mm.
6.3.2 Method
Choose ten points at random of any size and taper. Place each point on a visual measurement equipment
and measure the overall length.
If all ten points pass the requirement, the product passes. If eight or fewer points pass, the product fails. If
nine points pass, test five additional points. All five additional points shall comply for the product to pass.
6.4 Size designation
6.4.1 Equipment
An optical
...
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